The Latest Research on Muscle Invasive Bladder Cancer

Neoadjuvant cisplatin-based chemotherapy combinations have demonstrated five-year overall survival benefits of around 5%⁵ and pathologic complete responses rates of 36 to 42% with contemporary chemotherapy regimens.⁶ Read More

The Current Landscape of Neoadjuvant Chemotherapy in Cisplatin Eligible Patients with Clinically Localized, Muscle Invasive Bladder Cancer

Written by Rashid K. Sayyid, MD, MSc, and Zachary Klaassen, MD, MSc

March 21, 2023

Early treatment intensification with neoadjuvant cisplatin-based chemotherapy has long been advocated as means to improve survival outcomes in patients with clinically localized, muscle invasive disease undergoing definitive local therapy. Read More

The Current Landscape of Neoadjuvant Immunotherapy Agent Combinations in Patients with Clinically Localized, Muscle Invasive Bladder Cancer

Written by Rashid K. Sayyid, MD, MSc, and Zachary Klaassen, MD, MSc

March 20, 2023

While neoadjuvant cisplatin-based chemotherapy combinations have demonstrated five-year overall survival benefits of at least 5%,⁵ a significant proportion of patients remain “cisplatin ineligible”, defined by at least one of the following criteria. Read More

The Current Landscape of Neoadjuvant Single Agent Therapy in Patients with Cisplatin Ineligible Clinically Localized, Muscle Invasive Bladder Cancer

Written by Rashid K. Sayyid, MD, MSc, and Zachary Klaassen, MD, MSc

March 20, 2023

While the majority of patients are diagnosed with non-muscle invasive disease (i.e. carcinoma in situ, Ta, and T1), approximately 25 to 33% of patients are initially diagnosed with muscle invasive bladder cancer and a meaningful proportion of patients initially diagnosed with non-muscle invasive disease will subsequently progress to MIBC.¹ Read More

The Value of Multiparametric Magnetic Resonance Imaging Sequences to Assist in the Decision Making of Muscle-Invasive Bladder Cancer - Beyond the Abstract

Written by Marco Bandini, and Andrea Necchi

August 13, 2020

Over the last few years, the landscape of bladder cancer (BC) management has profoundly changed, thanks to increased knowledge of disease biology and the identification of novel therapeutic approaches and biomarkers.¹ No more than 5 years ago, the treatment-decision process for non muscle-invasive BC (NMIBC) or muscle-invasive BC (MIBC) was represented by radical surgery in most cases, with an opportunity for perioperative systemic therapy in a few cases. To date, the diagnostic and therapeutic armamentarium has been exceedingly enlarged for these patients. Read More

Physician-Scientist Commentaries

Peer-reviewed Abstract Supplemental Commentaries

Trends in the Diagnoses of Subtype Histologies in Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

The accurate diagnosis of histological subtypes in bladder cancer remains challenging with significant interobserver variability, yet proper identification is critical for optimal clinical management. A recent study analyzed the temporal trends in the diagnosis of bladder cancer histological subtypes in the United States

Evaluating Surrogate Endpoints for Adjuvant Chemotherapy of Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Surrogates for overall survival can expedite the development of adjuvant treatments for bladder cancer, yet careful data-driven validation of these endpoints is needed. A recent study evaluated whether disease-free survival (DFS) or distant metastasis-free survival (DMFS) are valid surrogates for overall survival (OS) in patients with muscle-invasive bladder cancer

Cost-effectiveness of Perioperative Durvalumab Plus Platinum-based Chemotherapy in Muscle Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Muscle-invasive bladder cancer (MIBC) requires multimodal treatment consisting of neoadjuvant chemotherapy followed by radical cystectomy. The NIAGARA trial recently established the benefit of adding perioperative immunotherapy with durvalumab to standard gemcitabine/cisplatin chemotherapy in MIBC.

Clinical Outcomes of Patients with MIBC Treated with Adjuvant Nivolumab - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Muscle-invasive urothelial carcinoma is associated with high recurrence rates despite standard radical surgery, with over 50% of patients experiencing disease recurrence within 2-3 years. A recent retrospective cohort study examined real-world effectiveness of adjuvant nivolumab, which received FDA approval based on the CheckMate 274 trial.

Cost-Effectiveness of Trimodal Therapy and Radical Cystectomy for MIBC in the United States - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Trimodal therapy (TMT) as an alternative to radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC), with recent retrospective analyses showing similar oncologic outcomes. However, comparative cost-effectiveness data are lacking. A recent study compares the cost-effectiveness of TMT versus RC from a Medicare perspective.

Hydronephrosis in Patients with Bladder Cancer Undergoing Chemoradiotherapy - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Muscle-invasive bladder cancer (MIBC) with hydronephrosis typically warrants radical cystectomy, though the impact of chemoradiotherapy (CRT) on hydronephrosis remains unclear. A recent study evaluated the incidence, etiology, and management of hydronephrosis before and following CRT in patients with MIBC.

Single-Cell RNA Sequencing Reveals Interaction Between Fibroblast Gene Signature and T-Cell Infiltration in Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Muscle-invasive bladder cancer (MIBC) is characterized by a complex tumor microenvironment that drives aggressive progression and treatment resistance; however, the key players in the microenvironment and their interactions are not well understood.

Neoadjuvant Sintilimab with Gemcitabine and Cisplatin for Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Radical cystectomy (RC) is the standard treatment for patients with Muscle-invasive bladder cancer (MIBC). However, it carries significant morbidity, perioperative mortality of about 5%, and negative impacts on quality of life. A recent phase 2 trial evaluated the efficacy and safety of neoadjuvant sintilimab (a PD-1 inhibitor) combined with gemcitabine

Neoadjuvant Durvalumab and Olaparib in Resectable Urothelial Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

More effective neoadjuvant treatments are needed for patients with muscle-invasive bladder cancer (MIBC). A recent phase II clinical trial evaluated the combination of anti-PDL1 inhibitor durvalumab and PARP inhibitor olaparib as neoadjuvant therapy, focusing on molecular dynamics in pre-treatment and post-treatment settings.

Trimodality Therapy Compared to Radical Cystectomy for Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Localized Muscle-invasive bladder cancer (MIBC) requires definitive treatment with curative intent. A recent systematic review and meta-analysis by Fong et al. compared survival outcomes between radical cystectomy (RC) and trimodality therapy (TMT) in patients with MIBC. The investigators conducted a literature search across PubMed, Embase, Scopus, and CENTRAL databases

Outcomes of Neoadjuvant Chemotherapy in Invasive Urothelial Carcinoma - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Neoadjuvant chemotherapy prior to radical cystectomy is a standard of care in patients with muscle-invasive bladder cancer. A retrospective multicenter study examined the contributions of preoperative clinical disease stage and chemotherapy to clinical outcomes. The investigators analyzed 513 patients who underwent RC for cT2-4N0-3M0 bladder cancer between 2010 and 2017.

A Clinical Trial of Adjuvant Nivolumab Following Chemoradiation in Localized Muscle-Invasive Urothelial Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Muscle-invasive urothelial cancer (MIUC) has a high recurrence risk following definitive treatment. A recent phase II single-arm trial evaluated nivolumab as adjuvant therapy following chemoradiation in patients with localized or locoregional urothelial carcinoma who were ineligible for or declined radical surgery.

Long-Term Outcomes of Robot-Assisted Radical Cystectomy in Patients with Non-Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Radical cystectomy is an effective treatment option for high-risk, non-muscle-invasive bladder cancer (NMIBC) to prevent progression. A recent 12-year multicenter study evaluated survival outcomes of patients with NMIBC who underwent robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD).

Oncolytic Adenoviral Therapy in Combination with Nivolumab in Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Neoadjuvant chemo-immuno therapy followed by radical cystectomy is the standard of care for patients with muscle-invasive bladder cancer (MIBC). However, up to 40% of patients are ineligible to receive Cisplatin-based chemotherapy. In a single-arm phase 1b trial, Li et al. investigated the safety and efficacy of combining

Outcomes after Radical Cystectomy in Patients with Primary Versus Secondary Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Patients with prostate cancer are at increased risk of developing radiation-induced secondary bladder cancer (RT-BC) due to external radiation therapy (EBRT) or brachytherapy (BT) for prostate cancer. However, there is a lack of data regarding survival differences after radical cystectomy (RC) between radiotherapy-exposed versus radiotherapy-unexposed patients with BC.

Transformative or Transitional? Deciphering the Role of NIAGARA in Shaping Future Practice - Beyond the Abstract

Written by Daniele Raggi, MD, & Prof. Robert A. Huddart, PhD

The phase 3 NIAGARA trial has introduced promising advancements in the treatment landscape for muscle-invasive bladder cancer (MIBC). By integrating perioperative durvalumab with neoadjuvant cisplatin-based chemotherapy, the study demonstrated statistically significant improvements in event-free survival (EFS) and overall survival (OS) compared to neoadjuvant chemotherapy alone. This pivotal finding positions the combination as a potential new standard of care for cisplatin-eligible MIBC patients.

Outcomes of Bladder-Preserving Radiation Therapy in Locally Advanced MIBC - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Up to 40% of patients with Muscle-invasive bladder cancer (MIBC) are ineligible for cisplatin-based neoadjuvant therapy or radical surgery due to comorbidities. Carriere et al. investigated the effects of bladder-preserving radiotherapy in LA-MIBC patients who are ineligible for or refuse radical cystectomy (RC).

Benefits of Comprehensive Geriatric Assessment in Older Patients with Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

The standard treatment for localized bladder cancer (BC) is neoadjuvant chemotherapy with cisplatin followed by radical cystectomy (RC), but this poses challenges for older patients due to high post-operative complications. An alternative approach, trimodal therapy (TMT), aims to preserve bladder function in selected patients.

Does the Extent of Transurethral Resection after Radiation Therapy Impact Survival Outcomes in Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

A current standard of care treatment for muscle-invasive bladder cancer (MIBC) is platinum-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC). Bladder-sparing protocols are available for patients who cannot or prefer not to receive surgery and include maximal transurethral resection of the bladder (TURBT)

The Feasibility and Efficacy of Multiparametric MRI for Staging Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Transurethral resection of bladder tumor (TURBT) is a diagnostic and staging tool for muscle-invasive bladder cancer (MIBC). However, staging may not be precise due to technical limitations. Distinguishing non-muscle invasive bladder cancer (NMIBC) from MIBC at an earlier time can expedite treatment selection and potentially enhance survival outcomes. James et al.

Prognostic Value of Longitudinal ctDNA in Patients with Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Neoadjuvant chemotherapy followed by radical cystectomy (RC) is a standard of care for patients with muscle-invasive bladder cancer (MIBC). Adjuvant treatment is recommended for patients with a high-risk of relapse. Biomarkers like circulating tumor DNA (ctDNA) could potentially predict relapse and guide adjuvant therapy.

A Novel Target for Enhancing Sensitivity to Platinum-Based Chemotherapy in MIBC - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Resistance to platinum-based chemotherapy is a significant concern in patients undergoing treatment for bladder cancer. A recent study, Jones et al. investigated the mechanisms driving chemoresistance, with the goal of discovering potential targets to improve treatment response.

Long-Term Outcomes in Patients with Localized Plasmacytoid Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

The plasmacytoid variant of bladder cancer (PV-BCa) is an aggressive subtype with a low 5-year survival rate. Mutations that lead to truncation of CDH1 are central to the pathology of PV-BCa and lead to loss of E-cadherin expression, which in turn allows the invasive spread of tumor cells.

The Clinical Impact of Delaying Radical Cystectomy in Muscle Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

The standard treatment for muscle-invasive bladder cancer (MIBC) is radical cystectomy (RC) with neoadjuvant chemotherapy (NAC). Although NAC is associated with a 5-10% increase in overall survival (OS) compared to RC alone, it is underutilized. The European Association of Urology recommends RC

Urine Tumor DNA-Informed Analysis of ctDNA in Patients with Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

The presence of circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) is indicative of relapse and worsening prognosis. Due to the practical barriers to sequencing tumor samples for ctDNA measurement, medical researchers have focused efforts on developing alternative assays.

Clinical Outcomes after Robot-Assisted Radical Cystectomy versus Open Radical - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Robot-assisted RC (RARC) procedures are popular due to faster recovery times. A recent study by Khetrapal et al. performed a systematic review and meta-analysis of randomized controlled trials (RCTs) – of outcomes in patients with bladder cancer who underwent RARC versus open RC (ORC). A total of seventeen studies were included in the analysis, which encompassed eight RCTs and 1,024 patients. 509 patents underwent ORC

Clinical Outcomes in Response to Perioperative Chemotherapy in Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

In patients with bladder cancer (BC), neoadjuvant chemotherapy after radical cystectomy (RC) has been found to enhance survival and is therefore considered a gold standard for treatment. Li et al. investigated long-term outcomes among BC patients who underwent RC with or without perioperative chemotherapy. A total of 1,700 patients were included in the study, among whom 805 underwent RC without any perioperative chemotherapy (NC)

Neoadjuvant Chemotherapy for Neuroendocrine Carcinoma of the Urinary Tract - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Neuroendocrine carcinoma of the urinary tract (NEC-URO) is a rare and aggressive variant of urothelial carcinoma (UC). There has been limited data on the optimal management for NEC-URO. Accordingly, Alhalabi et al. previously conducted a phase 2 study in which patients with NEC-URO received an alternating doublet treatment of chemotherapy with ifosfamide plus doxorubicin (IA) and etoposide plus cisplatin (EP).

Long-Term Results from the S1314 Study of Neoadjuvant Chemotherapy for Muscle Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

The standard of care for muscle-invasive bladder cancer (MIBC) is cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy. Studies have documented the clinical benefit of dose-dense methotrexate-vinblastine-adriamycin-cisplatin (ddMVAC) or gemcitabine plus cisplatin (GC). The COXEN approach was developed to use gene expression

Neutrophil-to-Lymphocyte Ratio as a Potential Biomarker in Patients with Localized Urothelial Carcinoma Treated with Chemotherapy - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

A standard of care treatment for patients with muscle-invasive bladder cancer (MIBC) is cisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy. Since this treatment modality is associated with significant toxicity, predicting patient response to treatment can prevent unnecessary adverse events and delays to effective treatment.

Neoadjuvant Gemcitabine-Carboplatin Versus Gemcitabine-Cisplatin in Patients with Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Patients with muscle-invasive bladder cancer (MIBC) typically receive cisplatin-based chemotherapy prior to radical cystectomy. However, around half of MIBC patients may be ineligible for cisplatin, therefore necessitating alternative treatment modalities.

Modeling PTEN and P53 Inactivation in Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

The molecular subtyping of muscle-invasive bladder cancer (MIBC) cases in recent years provided a framework for understanding the biology of the disease. There is a knowledge gap regarding whether specific molecular subtypes are driven by genetic alterations that can impact the underlying pathology.

Lymph Node Status as a Predictor of Clinical Outcomes in Patients with Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

Node-positive bladder cancer is a transitional step in the metastatic cascade between localized and metastatic disease. Wagner et al. examined the radiographical and pathological lymph node status as an independent predictor for survival following neoadjuvant gemcitabine and cisplatin in patients

Efficacy and Safety of Neoadjuvant Immunotherapy in Combination with Neoadjuvant Gemcitabine and Cisplatin - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine

For patients with muscle-invasive bladder cancer (MIBC), the gold standard for treatment is cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy. However, the response to neoadjuvant chemotherapy varies significantly, and additional regimens that enhance

A Phase II Open-label Randomized Controlled Trial of Adjuvant Chemohyperthermia in Patients with Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC) frequently require adjuvant therapy. The HIVEC-II study is a multi-center randomized controlled trial (RCT) that compared clinical outcomes of intermediate-risk NMIBC patients receiving hyperthermia and mitomycin C versus mitomycin C alone.

Real-World Data to Derive Biomarkers of Response to Therapy in Patients with Metastatic Urothelial Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Combining real-world data and electronic health records for biomarker discovery can inform future clinical trial designs. This is important given that most randomized controlled trials do not always investigate clinical biomarkers along with the tested drug. A recent study by Szabados et al.

Mutational Profiles of Urothelial Cancer Samples after Kidney Transplantation - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

There is a well-documented increase in the risk of cancer development after a kidney transplant. For example, Lim et al. recently published a whole-exome sequencing analysis of somatic mutations in patients who underwent kidney transplants and subsequently developed urothelial carcinoma.

Outcomes of Primary Versus Secondary Muscle-Invasive Bladder Cancer After Neoadjuvant Chemotherapy and Radical Cystectomy - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York

The use of cisplatin-based neoadjuvant chemotherapy has been shown to improve survival in muscle-invasive bladder cancer patients undergoing radical cystectomy. Benidir et al. aimed to investigate differences in pathologic and survival outcomes

Patient Outcomes After Concurrent Radical Cystectomy and Nephroureterectomy - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York

Primary bladder malignancy accounts for up to 95% of urothelial carcinomas (UC), and upper tract urothelial carcinoma (UTUC) accounts for the rest of UC cases. Radical cystectomy (RC) is the typical treatment for aggressive UC, while radical nephroureterectomy (RNU) is the treatment of choice for aggressive UTUC.

Adjuvant Nivolumab in Muscle-Invasive Urothelial Carcinoma – Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York

The role of adjuvant therapy in muscle-invasive urothelial carcinoma is unclear, despite the high risk of metastatic recurrence. Adjuvant cisplatin-based chemotherapy is challenging to administer, and some patients are ineligible for or decline neoadjuvant cisplatin-based chemotherapy.

Immune Cell Infiltration Predicts Response to Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York

Incorporating neoadjuvant chemotherapy (NAC) into the management of patients with localized muscle-invasive bladder cancer (MIBC) improves survival. However, due to multiple factors, NAC is still not effectively used in real-life settings.

Safety of Adjuvant Radiotherapy after Radical Cystectomy for High-Risk Muscle-Invasive Bladder Cancer – Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York

Muscle-invasive bladder cancer (MIBC) is associated with a high risk of developing pelvic recurrence. Although adjuvant external beam radiotherapy (EBRT) decreases the risk of local recurrence, it has been associated with severe toxicity.

Bladder EpiCheck Urine Methylation Test and Photodynamic Diagnostic Cystoscopy for the Surveillance of High-Risk Non-Muscle-Invasive Bladder Cancer – Expert Commentary

Written by Bishoy M. Faltas

Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York

Non-muscle invasive bladder cancer (NMIBC) has one of the highest local recurrence rates of any malignancy. The current standards of care for NMIBC surveillance are white light cystoscopy and urine cytology.

Antibiotic Therapy Impacts Outcomes in Neoadjuvant Immunotherapy of Patients with Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Immune checkpoint inhibitors (ICIs) have transformed the treatment paradigm in muscle-invasive bladder cancer (MIBC). However, not all patients have consistent responses to these agents, and predictive biomarkers are still needed.

The Efficacy of Neoadjuvant Cabazitaxel and Cisplatin in Patients with Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Cisplatin-based chemotherapy is the standard-of-care neoadjuvant treatment for patients with muscle-invasive bladder cancer (MIBC). Taxanes were evaluated previously combined with cisplatin in the neoadjuvant setting. However, it is unclear if cabazitaxel, a novel taxane, synergizes with cisplatin.

Comparing Preoperative Chemotherapy Regimens in Patients with Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Neoadjuvant cisplatin-based chemotherapy in patients with muscle-invasive bladder cancer (MIBC) before radical cystectomy improves overall survival. Commonly used neoadjuvant chemotherapy regimens include the combination of dose-dense methotrexate

A Risk Stratification Model for Intermediate-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Non-muscle-invasive bladder cancers (NMIBC) represent a heterogeneous group of tumors with variable clinical outcomes. Multiple risk features are incorporated in predicting the risk of recurrence and progression to muscle-invasive bladder cancer (MIBC).

Characteristics of Secondary Muscle-Invasive Bladder Cancer (MIBC) Following Pelvic Irradiation - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Radiation therapy is commonly used for the definitive and palliative treatment of pelvic malignancies. Secondary pelvic cancers have been reported after radiation therapy, including radiation-associated muscle-invasive bladder cancer (RA-MIBC).

Treatment Outcomes and Estimated Costs Associated with BCG Therapy for Patients with High-Risk Non-Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Non-muscle invasive bladder cancers (NMIBC) constitute the majority of bladder cancer diagnoses. NMIBCs are stratified based on the risk of progression to muscle-invasive disease into low, intermediate, and high-risk groups.

Tumor Microenvironment (TME) Predicts Response to Immunotherapy in Muscle-Invasive Bladder Cancer (MIBC) Tumors - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Gene expression profiling has successfully classified muscle-invasive bladder cancer (MIBC) tumors into distinct categories that differ in their genetic characteristics and tumor mutation burden (TMB). In addition to cancer-cell autonomous factors,

Nadofaragene Firadenovec, a Novel Gene Therapy-Based Treatment for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

A few bladder-sparing treatment options are available for BCG-unresponsive patients, including valrubicin and the recently FDA-approved pembrolizumab. However, additional treatment options that achieve a durable response are needed.

A Nomogram to Stratify Intermediate-Risk Non-Muscle-Invasive Bladder Cancer for Adjuvant Therapy - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

There is a need for accurate nomograms for predicting oncological outcomes in intermediate-risk non–muscle-invasive bladder cancer (NMIBC) patients. Such accurate tools can be used to guide decision

Nivolumab in Patients with Advanced Platinum-Resistant Urothelial Carcinoma: Efficacy, Safety, and Biomarker Analyses with Extended Follow-Up from CheckMate 275 - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Nivolumab is an FDA-approved immune checkpoint for treating platinum-resistant metastatic or surgically unresectable urothelial carcinoma (mUC). The development of predictive biomarkers

Outcomes of Open Versus Robotic Radical Cystectomy for Bladder Cancer Patients - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Radical cystectomy continues to be the mainstay curative modality for bladder cancer patients. Understanding the long-term clinical outcomes of robotic and open radical cystectomy is critical for decision making.

Intravesical Doxorubicin Following Resection of Primary Non-muscle-invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Effective intravesical postoperative chemotherapy can reduce the risk of bladder cancer recurrence. A recent study by Fukuokaya et al. published in Clinical Genitourinary Cancer examined

Intravesical BCG Versus Radical Cystectomy for High-Risk NMIBC with Histologic Variants - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

The optimal management of non-muscle invasive bladder cancer (NMIBC), some histologic variants, including squamous and glandular, is challenging. A recent article published by Suh et al. in Scientific Reports compared Bacillus Calmette-Guérin

Gender Disparities in Clinical Outcomes after Cystectomy - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Understanding the demographic factors which affect clinical outcomes following radical cystectomy (RC) is critical for improving oncologic outcomes for all patients. A recent study published in European Urology Oncology examined intraoperative

BCG Immunotherapy Versus Radical Cystectomy in Intermediate or High-Risk Non-Muscle Invasive Bladder Cancer Patients - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Treatment options available for intermediate or high-risk non-muscle invasive bladder cancer include intravesical Bacillus Calmette-Guerin (BCG) and radical cystectomy.

Immunohistochemical Markers for Risk Stratification of Patients with Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

The relationship between the expression of GATA3, cytokeratin (CK) 20, CK 5/6, and p53 and survival in patients with muscle-invasive bladder cancer (MIBC) is not well characterized.

Monthly Maintenance Intravesical Combination Gemcitabine/Docetaxel for Non Muscle-invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Bacillus Calmette-Guerin shortage is a critical access issue for patients with non-muscle-invasive bladder cancer (NMIBC). Defining the efficacy of alternative intravesical treatments is an active area of investigation.

Does Pathologic Response to Neoadjuvant Chemotherapy Predict Survival in Muscle-Invasive Bladder Cancer Patients? - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Patients who achieved a pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) have a better prognosis compared to patients with pathologic residual disease (pRD).

Efficacy and Safety of Neoadjuvant Pembrolizumab in Patients with Muscle-Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Neoadjuvant chemotherapy followed by radical cystectomy (RC) with lymph node dissection is the standard of care in patients with muscle-invasive urothelial bladder carcinoma (MIBC).

Comparing the Outcomes of ddMVAC vs. GC before Cystectomy in Patients with Muscle Invasive Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Patients with muscle-invasive bladder cancer (MIBC) who are treated with neoadjuvant chemotherapy (NAC) before cystectomy have a survival advantage.

Outcomes of Partial Cystectomy for Selected Bladder Cancer Patients - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Radical cystectomy (RC) is currently the gold standard operative treatment for localized (T2-T4a) muscle-invasive bladder cancer (MIBC) or recurrent high-risk non-MIBC.

The Significance of Persistent Muscle Invasive After Neoadjuvant Chemotherapy - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Downstaging of muscle-invasive bladder cancer (MIBC) following neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) has been correlated with higher survival rates.

Adjuvant Chemotherapy in Patients with Urothelial Carcinoma and Adverse Pathologic Features Receiving Prior Neoadjuvant Chemotherapy and Radical Cystectomy - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Neoadjuvant chemotherapy is a standard of care for patients with cisplatin-eligible muscle-invasive urothelial carcinoma.

Neoadjuvant Chemotherapy Prior to Radical Cystectomy for Muscle-Invasive Bladder Cancer with Variant Histology - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Neoadjuvant chemotherapy is a standard of care for patients with urothelial muscle-invasive bladder cancer.

Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients with Locally Advanced Bladder Cancer - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Methotrexate-vinblastine-doxorubicin-cisplatin (MVAC) neoadjuvant chemotherapy is a standard of care for muscle-invasive urothelial bladder cancer.

Do Molecular Subtypes of Muscle-invasive Bladder Cancer Predict Response to Neoadjuvant Chemotherapy? - Expert Commentary

Written by Bishoy M. Faltas, MD

Englander Institute for Precision Medicine, Weill Cornell Medicine

Neoadjuvant chemotherapy is a standard of care for muscle-invasive bladder cancer (MIBC).

Conference Coverage

Conference Highlights Written by Physician Scientists

ASCO 2026: Feasibility and Safety Results from RAD-IO: A Multi-Stage Trial of Durvalumab with Chemoradiotherapy with 5-FU and Mitomycin C in Pts with MIBC

Presented by Nicholas James, MBBS, PhD

The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting was host to a session on new approaches to curing bladder and kidney cancer. Dr. Nicholas James presented the feasibility and safety results from RAD-IO, a multi-stage trial of durvalumab plus chemoradiotherapy with 5-FU and mitomycin C in patients with muscle invasive bladder cancer (MIBC). Read More

ASCO 2026: Perioperative SHR-A2102, a Novel Nectin-4-Targeted ADC, in Combination with Adebrelimab for Patients with MIBC: Results from a Phase 2/3 Study

Presented by Yijun Shen, MD

The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting was host to a kidney and bladder cancers oral abstract session. Dr. Yijun Shen presented the results of a phase 2/3 trial evaluating perioperative SHR-A2102, a novel nectin-4-targeted antibody-drug conjugate (ADC), in combination with adebrelimab for patients with muscle invasive bladder cancer (MIBC). Read More

ASCO 2026: Intravesical Recombinant BCG Combined with Chemo-IO as Perioperative Therapy for Patients with MIBC: Primary Analysis of SAKK 06/19

Presented by Richard Cathomas, MD

The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting was host to a kidney and bladder cancers oral abstract session. Dr. Richard Cathomas presented the primary analysis of SAKK 06/19 evaluating intravesical recombinant BCG combined with chemotherapy + immunotherapy (chemi0IO) as perioperative therapy for patients with muscle invasive bladder cancer (MIBC). Read More

AUA 2026: How to Assess Response After Perioperative Enfortumab Vedotin and Pembrolizumab in MIBC

Presented by Elaine Lam, MD

In a presentation titled, “How to Assess Response After Perioperative Enfortumab Vedotin and Pembrolizumab in MIBC,” Dr. Elaine Lam reviewed the rapidly evolving evidence supporting perioperative enfortumab vedotin plus pembrolizumab (EV+P), discussed how to define and measure clinical complete response (cCR), and outlined the key unanswered questions that will shape next-generation bladder-sparing clinical trials. Read More

AUA 2026: Adding Upfront, Perioperative Durvalumab vs Adopting Risk-Adapted Adjuvant Nivolumab? Cost-Effectiveness Analysis of Competing Treatment Strategies for Cisplatin-Eligible MIBC in the Era of Immune Checkpoint Inhibitors

Presented by Zhuo Su, MD

The 2026 AUA annual meeting featured an invasive bladder cancer session and a presentation by Dr. Zhuo Su discussing a cost-effectiveness analysis of competing treatment strategies for cisplatin-eligible muscle invasive bladder cancer in the era of immune checkpoint inhibitors. Read More

EAU 2026: State-of-the-Art Lecture Who Really Needs Surgery after Neo-Adjuvant

Presented by Alexandre R. Zlotta, MD, PhD, FRCSC

The 2026 European Association of Urology (EAU) Annual Meeting held in London, U.K., was host to the Urothelial Cancer: Towards Integrated Therapeutic Strategies plenary session. Dr. Alexandre Zlotta delivered the state-of-the-art lecture Who Really Needs Surgery after Neo-adjuvant Chemotherapy? Read More

EAU 2026: Debate: Beyond the Muscle: Redefining MIBC Management: Pro: ctDNA Should Guide Adjuvant Decisions

Presented by Jørgen Bjerggaard Jensen, MD

The 2026 European Association of Urology (EAU) Annual Meeting held in London, U.K., was host to the Urothelial Cancer: Towards Integrated Therapeutic Strategies plenary session. Dr. Jørgen Bjerggaard Jensen, in the Beyond the Muscle debate session on Redefining MIBC management, discussed the pros of ctDNA and how it should guide adjuvant decisions. Read More

EAU 2026: State-of-the-Art Lecture Bladder-Sparing in MIBC: The Real-World Evidence

Presented by Jeremy Teoh, MBBS, FRCSEd (Urol), FCSHK, FHKAM (Surgery)

The 2026 European Association of Urology (EAU) Annual Meeting held in London, U.K., between March 13^t^h and 16^th 2026, was host to the Urothelial Cancer: Towards Integrated Therapeutic Strategies plenary session. Dr. Jeremy Teoh presented the state-of-the-art lecture, Bladder-sparing in MIBC: The Real-world Evidence. Read More

EAU 2026: MIBC Systemic Therapy: Maximise Early or Strategize Post-op?

Presented by Matthew Galsky, MD

The European Association of Urology (EAU) 2026 Annual Congress was host to the “Common Problems and Controversies in Bladder Cancer: Rapid-Fire Debates” session, developed and led by Dr. Ashish Kamat. Dr. Matthew Galsky presented a case study, following which Drs. Thomas Powles and Patrizia Giannatempo debated whether all muscle-invasive bladder cancer (MIBC) patients planned for a radical cystectomy should receive peri-operative immune-oncology (IO)-based therapy or neoadjuvant chemotherapy (NAC) followed by risk-adapted adjuvant IO therapy. Read More

ASCO GU 2026: ctDNA to Guide Response-Adapted Bladder Preservation in MIBC: Integrated Analysis of the RETAIN Trials

Presented by Pooja Ghatalia, MD

The 2026 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Pooja Ghatalia discussing an integrated analysis of the RETAIN trials assessing ctDNA to guide response-adapted bladder preservation in muscle-invasive bladder cancer. Read More

ASCO GU 2026: Neoadjuvant and Adjuvant Enfortumab Vedotin + Pembrolizumab for Participants with MIBC Who Are Eligible for Cisplatin: Randomized, Open-Label, Phase 3 KEYNOTE-B15 Study

Presented by Matthew D. Galsky, MD

The 2026 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Matthew Galsky discussing results from the randomized, open-label, phase 3 KEYNOTE-B15 study assessing neoadjuvant and adjuvant enfortumab vedotin + pembrolizumab for participants with muscle invasive bladder cancer who are eligible for cisplatin. Read More

SUO 2025: Prognostic Performance of a CHAI Biomarker in Muscle Invasive Bladder Cancer

Presented by Yair Lotan, MD

The 2025 SUO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Yair Lotan discussing the prognostic performance of a computational histology artificial intelligence (CHAI) biomarker in muscle-invasive bladder cancer. Read More

ESMO 2025: Perioperative Enfortumab Vedotin (EV) plus Pembrolizumab (Pembro) in Participants with Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin-Ineligible: The Phase 3 KEYNOTE-905 Study

Presented by Christof Vulsteke, MD, PhD

The 2025 European Society of Medical Oncology (ESMO) Annual Congress held in Berlin, Germany between September 17^th and 21^st was host to the session Presidential Symposium 1. Dr. Christof Vulsteke presented the LBA2 - Perioperative (enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study. Read More

ESMO 2025: Enfortumab Vedotin + Pembrolizumab in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer: An Exploratory Analysis in Older Patients and Those With Comorbidities from EV-302

Presented by Nataliya Mar, MD

The 2025 European Society for Medical Oncology (ESMO) Annual Congress held in Berlin, Germany, was host to a urothelial carcinoma poster session. Dr. Nataliya Mar presented the results of an exploratory analysis of the EV-302 trial of enfortumab vedotin + pembrolizumab (EV+P) in older patients with previously untreated locally advanced or metastatic urothelial carcinoma. Read More

ESMO 2025: Neoadjuvant Gemcitabine Intravesical System (TAR-200) + Cetrelimab or Cetrelimab Alone in Patients with MIBC: SunRISe-4 Primary Analysis and Biomarker Results

Presented by Andrea Necchi, MD

The 2025 ESMO annual meeting featured a urothelial carcinoma mini oral session and a presentation by Dr. Andrea Necchi discussing the SunRISe-4 primary analysis and biomarker results assessing neoadjuvant TAR-200 + cetrelimab or cetrelimab alone in patients with muscle-invasive bladder cancer. The standard of care for muscle-invasive bladder cancer (T2-T4aN0M0) is radical cystectomy + neoadjuvant chemotherapy, or chemoradiation for select patients. Read More

ESMO 2025: Randomized Comparison of Upfront MRI versus Transurethral Resection for Staging New Bladder Cancers: Final Survival Analysis from the BladderPath Trial

Presented by Nicholas D. James, MBBS, PhD

The 2025 ESMO annual meeting featured a urothelial carcinoma mini oral session and a presentation by Dr. Nicholas D. James discussing final survival analysis results from the BladderPath trial assessing upfront MRI versus transurethral resection for staging new bladder cancers. TURBT has been the mainstay of bladder cancer staging for more than 60 years. Read More

ESMO 2025: A Blinded, Exploratory Phase 2 Trial of Nivolumab and the GDF-15 Neutralizing Antibody Visugromab or Placebo as Neoadjuvant Treatment of Patients with MIBC: Primary Results of the GDFather-NEO Trial

Presented by Andrea Necchi, MD

The 2025 ESMO annual meeting featured a urothelial carcinoma proffered paper session and a presentation by Dr. Andrea Necchi discussing primary results of the GDFather-NEO trial, a blinded, exploratory phase 2 trial of nivolumab and the GDF-15 neutralizing antibody visugromab or placebo as neoadjuvant treatment of patients with muscle-invasive bladder cancer. Approximately 50% of patients with muscle invasive bladder cancer Read More

ESMO 2025: Health Related Quality of Life Outcomes from the NIAGARA Trial of Perioperative Durvalumab + Neoadjuvant Chemotherapy in MIBC

Presented by Michiel S. Van der Heijden, MD, PhD

The 2025 ESMO annual meeting featured a urothelial carcinoma mini oral session and a presentation by Dr. Michiel Van der Heijden discussing health related quality of life outcomes from the NIAGARA trial of perioperative durvalumab + neoadjuvant chemotherapy in muscle invasive bladder cancer. In the phase 3 NIAGARA trial,¹ patients with muscle invasive bladder cancer treated with perioperative durvalumab Read More

ESMO 2025: Adjuvant Nivolumab versus Placebo for High-Risk Muscle Invasive Urothelial Carcinoma: 5-Year Efficacy and ctDNA Results from CheckMate 274

Presented by Matthew D. Galsky, MD

The 2025 ESMO annual meeting featured a urothelial carcinoma proffered paper session and a presentation by Dr. Matthew Galsky discussing 5-year efficacy and ctDNA results from CheckMate 274 assessing adjuvant nivolumab versus placebo for high-risk muscle invasive urothelial carcinoma. Despite standard of care, radical cystectomy with or without neoadjuvant cisplatin-based chemotherapy, a significant number of patients with muscle invasive urothelial carcinoma Read More

ASCO 2025: EV-302: Long-Term Subgroup Analysis from the Phase 3 Global Study of Enfortumab Vedotin in Combination with Pembrolizumab (EV+P) vs Chemotherapy (Chemo) in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

Presented by Jens Bedke, MD

Jens Bedke, MD, presented Poster 4571: EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). Read More

ASCO 2025: Exploratory Analysis of Responders from the Phase 3 EV-302 Trial of Enfortumab Vedotin + Pembrolizumab Versus Chemotherapy in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma

Presented by Shilpa Gupta, MD

The 2025 ASCO annual meeting featured a urothelial carcinoma oral abstract session and a presentation by Dr. Shilpa Gupta discussing an exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin + pembrolizumab versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma. Read More

ASCO 2025: Circulating Tumor DNA in Patients with MIBC Who Received Perioperative Durvalumab in NIAGARA

Presented by Thomas Powles, MD

The 2025 ASCO annual meeting featured a urothelial carcinoma oral abstract session and a presentation by Dr. Thomas Powles discussing circulating tumor DNA in patients with muscle invasive bladder cancer who received perioperative durvalumab in NIAGARA. Read More

EAU 2025: State-of-the-Art Lecture: Role of Perioperative Neoadjuvant/Adjuvant Therapy in the Management of Bladder and Kidney Cancer

Presented by Philippe Spiess, BS, MS, MD, FRCS, FACS

The 2025 European Association of Urology (EAU) Annual Meeting held in Madrid, Spain between March 21^st and 24^th 2025, was host to the Biomarkers to guide peri-operative management in Uro-oncology Plenary Session. Dr. Philippe Spiess delivered a presentation discussing the role of Perioperative Neoadjuvant/Adjuvant Therapy in the Management of Bladder and Kidney Cancer. Read More

EAU 2025: Rapid-Fire Debate: How Radical Should a TURBT Be in MIBC? Only Diagnostic TURBT Is Sufficient

Presented by Marco Moschini

The 2025 EAU annual meeting featured a rapid-fire debate session on common problems and controversies in bladder cancer and a presentation by Dr. Marco Moschini contending that for muscle invasive bladder cancer, only a diagnostic Read More

EAU 2025: Rapid-Fire Debate: How Radical Should a TURBT Be in MIBC? a Maximal TURBT Is Needed

Presented by Fredrik Liedberg, MD

The 2025 EAU annual meeting featured a rapid-fire debate session on common problems and controversies in bladder cancer and a presentation by Dr. Fredrik Liedberg contending that for muscle invasive bladder cancer, a maximal TURBT is needed.
Read More

ASCO GU 2025: EV-302: Updated Analysis from the Phase 3 Global Study of Enfortumab Vedotin in Combination with Pembrolizumab (EV+P) vs Chemotherapy (Chemo) in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

Presented by Thomas Powles, MBBS, MRCP, MD

The 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Annual Symposium held in San Francisco, CA between February 13–15, 2025 was host to a urothelial carcinoma rapid oral abstract session. Dr. Thomas Powles presented an updated analysis from the phase III global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). Read More

ASCO GU 2025: Discussant: Advancements in Urothelial Cancer Perioperative Therapy

Presented by Scot A. Niglio, MD

The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a discussant presentation by Dr. Scot Niglio discussing two abstracts: “Safety and efficacy of neoadjuvant immunotherapy with durvalumab in combination with neoadjuvant chemotherapy (gemcitabine/cisplatin or carboplatin) in patients with operable high-risk upper tract urothelial carcinoma” by Dr. Nadine Houede, and “Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with muscle-invasive bladder cancer with HER2 expression: Updated efficacy and safety results from the phase II RC48-C017 trial” by Dr. Xinan Sheng. Read More

ASCO GU 2025: Discussant: Adjuvant Immunotherapy in High Risk Muscle Invasive Bladder Cancer

Presented by Elizabeth R. Plimack, MD

The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a discussant presentation by Dr. Elizabeth Plimack discussing two abstracts: “Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: Additional efficacy outcomes including overall survival in patients with muscle-invasive bladder cancer from CheckMate 274” by Dr. Matthew Milowsky, and “Additional efficacy and safety outcomes and an exploratory analysis of the impact of pathological complete response on long-term outcomes from NIAGARA” by Dr. Matthew Galsky. Read More

ASCO GU 2025: Adjuvant Nivolumab vs Placebo for High-Risk Muscle-Invasive Urothelial Carcinoma: Additional Efficacy Outcomes Including Overall Survival in Patients with MIBC from CheckMate 274

Presented by Matthew I. Milowsky, MD, FASCO

The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Matthew Milowsky discussing additional efficacy outcomes in patients with muscle-invasive bladder cancer from CheckMate 274 assessing adjuvant nivolumab versus placebo. Read More

ASCO GU 2025: Additional Efficacy and Safety Outcomes and an Exploratory Analysis of the Impact of Pathological Complete Response on Long-Term Outcomes from NIAGARA

Presented by Matthew D. Galsky, MD

The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Matthew Galsky discussing additional efficacy and safety outcomes and an exploratory analysis of the impact of pathological complete response on long-term outcomes from NIAGARA. Read More

ASTRO 2024: Bladder Preservation - A Modern Choice for Patients

Presented by Leslie Ballas, MD, FASTRO

The 2024 ASTRO annual meeting was host to the session Presidential Symposium: Innovations in Genitourinary Cancers: Session II - Bladder Preservation - A Modern Choice for Patients. Dr. Leslie Ballas opened this session with a talk titled: Bladder Preservation - A Modern Choice for Patients. Read More

IBCN 2024: Systematic Evaluation of Differentially Expressed Genes Associated with Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer

Presented by Aymeric Zadoroznyj, MD

The 2024 IBCN annual meeting included a session on treatment response correlates, featuring a presentation by Dr. Aymeric Zadoroznyj discussing the systematic evaluation of differentially expressed genes associated with response to neoadjuvant chemotherapy in muscle invasive bladder cancer. Neoadjuvant cisplatin-based combination chemotherapy is standard of care for patients with muscle-invasive bladder cancer. Read More

IBCN 2024: Quantifying Intra-tumoral Molecular Subtype Heterogeneity in MIBC from Histological Slides using a deep learning approach in the VESPER Trial

Presented by Jacqueline Fontugne, MD

The 2024 IBCN annual meeting included a session on treatment response correlates, featuring a presentation by Dr. Jacqueline Fontugne discussing quantification of intra-tumoral molecular subtype heterogeneity in muscle invasive bladder cancer from histological slides using a deep learning approach in the VESPER trial. Read More

IBCN 2024: TAR-200 Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Patients With Muscle-Invasive Bladder Cancer Who Are Ineligible for or Refuse Neoadjuvant Platinum-Based Chemotherapy: Interim Analysis of SunRISe-4

Presented by Andrea Necchi, MD

The 2024 IBCN annual meeting included a session on novel therapies and outcome measures in clinical trials, featuring a presentation by Dr. Andrea Necchi discussing the interim analysis of SunRISe-4, assessing TAR-200 + cetrelimab or cetrilumab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer. Read More

IBCN 2024: Circulating Immune-Modulators of Response to Neoadjuvant Nivolumab + Nab-Paclitaxel in Muscle Invasive Bladder Cancer: Biomarker Analyses from Nure-COMBO Trial

Presented by Brigida Maiorano, MD

The 2024 IBCN annual meeting included a session on advancements in circulating biomarkers, featuring a presentation by Dr. Brigida Maiorano discussing the biomarker analysis from the Nure-COMBO trial assessing neoadjuvant nivolumab + nab-paclitaxel in muscle invasive bladder cancer. Read More

IBCN 2024: Correlation of ctDNA Dynamics with Clinical Response in MIBC Patients Undergoing Trimodality Therapy

Presented by Kent Mouw, MD, PhD

The 2024 IBCN annual meeting included a session on advancements in circulating biomarkers, featuring a presentation by Dr. Kent Mouw discussing the correlation of ctDNA dynamics with clinical response in muscle-invasive bladder cancer patients undergoing trimodality therapy. Read More

IBCN 2024: Dynamic Monitoring of Circulating Tumor DNA to Predict Prognosis in Muscle-Invasive Bladder Cancer Patients After Radical Cystectomy

Presented by Lourdes Mengual, PhD

The 2024 IBCN annual meeting included a session on advancements in circulating biomarkers, featuring a presentation by Dr. Lourdes Mengual discussing dynamic monitoring of circulating tumor DNA (ctDNA) to predict prognosis in muscle-invasive bladder cancer patients after radical cystectomy. Read More

ESMO 2024: Identification of Bladder Cancer Patients That Could Benefit from Early Post-Cystectomy Immunotherapy Based on Serial Circulating Tumour DNA Testing: Preliminary Results from the TOMBOLA Trial

Presented by Jørgen Bjerggaard Jensen, MD

The 2024 ESMO Annual Congress was host to a proffered paper session for non-prostate genitourinary malignancies. Dr. Jørgen Bjerggaard Jensen presented the preliminary results from the TOMBOLA trial, which evaluated whether serial circulating tumour DNA (ctDNA) testing could be used to identify bladder cancer patients that could benefit from early post-cystectomy immunotherapy. Read More

ESMO 2024: Invited Discussant: A Randomized Phase 3 Trial of Neoadjuvant Durvalumab plus Chemotherapy Followed by Radical Cystectomy and Adjuvant Durvalumab in Muscle-Invasive Bladder Cancer (NIAGARA)

Presented by Petros Grivas MD, PhD

The 2024 ESMO was host to the session Presidential Symposium and Dr. Petros Grivas discussed the presentation by Dr. Thomas B. Powles who presented the results of the NIAGARA trial, a randomized phase 3 trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer. Read More

ESMO 2024: Randomized Phase 3 Trial of Neoadjuvant Durvalumab plus Chemotherapy Followed by Radical Cystectomy and Adjuvant Durvalumab in Muscle-Invasive Bladder Cancer (NIAGARA)

Presented by Thomas B. Powles, MBBS, MRCP, MD

The 2024 ESMO Annual Congress was host to the session Presidential Symposium II: Practice-changing trials. Dr. Thomas B. Powles presented the results of the NIAGARA trial, the first randomized phase 3 trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer. Read More

ESMO 2024: EV-302: Exploratory Analysis of Nectin-4 Expression and Response to 1L Enfortumab Vedotin (EV) + Pembrolizumab (P) in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

Presented by Thomas B. Powles, MBBS, MRCP, MD

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to the session Mini oral session: GU tumours, non-prostate. Dr. Thomas B. Powles presented an exploratory analysis of Nectin-4 Expression and Response to first line Enfortumab Vedotin (EV) + Pembrolizumab (P) in previously Untreated patients with locally advanced or metastatic urothelial cancer (UC). Read More

ESMO 2024: Invited Discussant: Improving Outcomes of Localized Urothelial Cancer

Presented by Maria De Santis, MD, PhD

At the 2024 ESMO annual meeting, Dr. Maria De Santis discussed three key urothelial carcinoma abstracts: updated SunRISe-1 results on TAR-200 +/- cetrelimab in BCG-unresponsive high-risk NMIBC, the AMBASSADOR study on adjuvant pembrolizumab in muscle-invasive urothelial carcinoma, and ctDNA clearance in cisplatin-ineligible MIBC from the VOLGA trial.

ESMO 2024: Alliance A031501: AMBASSADOR Study of Adjuvant Pembrolizumab in Muscle-Invasive Urothelial Carcinoma vs Observation: Extended Follow-up DFS Results and Metastatic Disease Recurrence Distribution

Presented by Andrea Apolo

(UroToday.com) The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Andrea Apolo, discussing extended follow-up for disease free survival and an assessment of metastatic disease recurrence pattern from the AMBASSADOR study of adjuvant pembrolizumab Read More

ASCO 2024: Enfortumab Vedotin with Pembrolizumab Versus Chemotherapy in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma: Analysis of Cisplatin-Eligible Population from EV-302/KEYNOTE-A39

Presented by Jens Bedke, MD

The 2024 ASCO annual meeting was host to a presentation by Dr. Jens Bedke who presented their poster titled: Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of cisplatin (cis)-eligible population from EV-302/KEYNOTE-A39. Read More

ASCO 2024: Enfortumab Vedotin with Pembrolizumab Versus Chemotherapy in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC): Analysis of the Cisplatin-Ineligible Population from EV-302/KEYNOTE-A39

Presented by Michiel Simon Van Der Heijden, MD, PhD

The 2024 ASCO annual meeting was host to a presentation by Dr. Michiel Simon Van Der Heijden presenting a secondary analysis of the cisplatin (cis)-ineligible population from EV-302/KEYNOTE-A39 comparing Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). Read More

ASCO 2024: Study EV-103: Neoadjuvant Treatment with Enfortumab Vedotin Monotherapy in Cisplatin-Ineligible Patients with Muscle Invasive Bladder Cancer (MIBC) 2-Year Event-Free Survival and Safety Data for Cohort H

Presented by Peter H. O'Donnell, MD

The 2024 ASCO annual meeting was host to a presentation by Dr. Peter H. O'Donnell, who presented the study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)—2-year event-free survival and safety data for Cohort H. Read More

EAU 2024: State-of-the-Art Lecture: New Standard Treatment for Metastatic Bladder Cancer Based on EV-302/KEYNOTE-A39

Presented by Andrea Necchi, MD

(UroToday.com) The 2024 European Association of Urology (EAU) annual meeting featured a plenary session on living with advanced kidney cancer and urothelial cancer, and a state of the art lecture by Dr. Andrea Necchi discussing whether there is a new standard treatment of metastatic bladder cancer based on EV-302/KEYNOTE-A39. Read More

EAU 2024: Rapid Fire Debate 4: Patient with MIBC After Radical Cystectomy – Can We Use ctDNA to Guide Decisions on Adjuvant Chemo/IO? What About utDNA for Bladder Sparing After NAC?

Presented by Andrea Necchi, MD, Peter Black, MD, Jørgen Bjerggaard Jensen, MD, DMSc

The 2024 European Association of Urology (EAU) annual congress held in Paris, France between April 5^th and 8^th was host to a plenary session addressing imaging-related controversies for the staging of genitourinary cancers. Professors Andrea Necchi, Peter Black, and Jørgen Bjerggaard participated in a rapid-fire debate discussing whether we can use circulating tumor DNA (ctDNA) and/or urine tumor DNA (utDNA) in patients with muscle-invasive bladder cancer (MIBC) following radical cystectomy to guide treatment decision on adjuvant therapy. Read More

EAU 2024: No Need for TURBT, VI-RADS Makes the Diagnosis

Presented by Valeria Panebianco, MD

The 2024 European Association of Urology (EAU) annual congress held in Paris, France between April 5^th and 8^th was host to a plenary session addressing imaging-related controversies for the staging of genitourinary cancers. Professor Valeria Panebianco discussed the Vesical Imaging-Reporting and Data System (VI-RADS) and its potential to replace/complement transurethral resection of bladder tumor (TURBT) for diagnosing bladder cancer. Read More

ESMO 2023: The Role of Systemic Therapy in Bladder Preservation for Muscle-Invasive Bladder Cancer

Presented by Elizabeth R. Plimack, MD, MS

The 2023 ESMO Annual Congress held in Madrid, Spain between October 20th and 24th, 2023 was host to a bladder preservation strategies oral session. Dr. Elizabeth Plimack discussed the role of systemic therapy in bladder preservation for patients with muscle-invasive bladder cancer (MIBC). Read More

AUA 2023: Neoadjuvant Immunotherapy for Muscle-Invasive Bladder Cancer

Presented by Srikala Sridhar, MD, MSc, FRCSC

In this presentation, Dr. Srikala Sridhar gave a talk on the role of neoadjuvant immunotherapy (IO) for muscle-invasive bladder cancer (MIBC). As she notes off the bat, MIBC is a highly aggressive systemic disease with poor long-term outcomes. Neoadjuvant cisplatin-based chemotherapy (NAC) remains the standard of care Read More

ASCO 2022: Perioperative Chemoimmunotherapy With Durvalumab for Operable Muscle-Invasive Urothelial Carcinoma: Primary Analysis of the Single Arm Phase II Trial SAKK 06/17

At the 2022 ASCO annual meeting, the poster discussion session that focused on Kidney and Bladder cancers included a presentation from Dr. Richard Cathomas discussing the role of peri-operative chemoimmunotherapy for patients undergoing radical cystectomy for muscle invasive urothelial carcinoma based on the SAKK 06/17 trial. Read More

ASTRO 2021: Controversies in the Management of Muscle-Invasive Bladder Cancer

Presented by Alejandro Berlin, MD MSc

In the Latin America ASTRO session of the American Society for Radiation Oncology (ASTRO) Annual Congress, Dr. Berlin presented on controversies in the management of patients with Muscle-invasive bladder cancer (MIBC). Read More

EAU 2021: Circulating Tumor Cell-Driven Use of Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer: Final Results of the CirGuidance Study

Presented by Nick Beije, MD, Ph.D and Morgan Roupret, MD, Ph.D

Dr. Nick Beije of Rotterdam, presented the final results of the CirGuidance Study, which focused on the use of the circulating tumor cells (CTCs) to drive neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC). This was followed by a discussion and summary from Dr. Morgan Roupret. Read More

SES AUA 2021: Modern Bladder Cancer Warfare: Does "Leave No Bladder Behind" Ethos Still Apply?

Presented by Alex Kutikov, MD, FACS

The State of the Art lecture at the 2021 virtual annual meeting of the Southeastern Section of the AUA was provided by Dr. Alex Kutikov who discussed the current applications for radical cystectomy and perhaps to spare certain bladders while minimizing risk of disease progression. Read More

SUO 2019: Immunotherapy in Bladder Cancer: Targets and Surgical Timing

Presented by Karen M. Wheeler, MD

Washington, DC (UroToday.com) As part of the Research Scholars Update at the 20th Annual Meeting of the Society of Urologic Oncology, Dr. Karen Wheeler presented her work on Read More

SUO 2019: Organ Preservation in Urologic Cancers - Muscle-Invasive Bladder Cancer

Presented by Robert Huddart, MA, MBBS, MRCP, FRCR

Washington, DC (UroToday.com) Organ preservation in bladder cancer has been a widely debated topic with polarizing views from different centers and researchers worldwide. Read More

SIU 2019: Debate - Chemotherapy is Better than Immunotherapy as Neoadjuvant Therapy for Muscle Invasive Bladder Cancer

Presented by Roland Seiler, PhD

Athens, Greece (UroToday.com) Dr. Roland Seiler presented after Dr. Andrea Necchi, supporting the role of chemotherapy in the neoadjuvant setting of treating muscle invasive bladder cancer Read More

SIU 2019: pT0 after Neoadjuvant Chemotherapy for Muscle Invasive Urothelial Carcinoma of the Bladder: Implications for Bladder Preservation

Presented by Kelly Stratton, MD

Athens, Greece (Urotoday.com) Neoadjuvant chemotherapy (NAC) in bladder cancer has been proven to improve overall survival in patients with muscle-invasive bladder cancer Read More

IBCN 2019: Genomic Classifier to Predict Luminal Bladder Tumors

Presented by Joep J. de Jong

Aarhus, Denmark (UroToday.com) Joep J. de Jong from the Erasmus MC Cancer Institute in Rotterdam discussed efforts at developing a genomic classifier to predict clinically Read More

ASCO GU 2019: Genomic Insights and Biomarkers for Treatment Selection in Muscle-Invasive and Non-Muscle-Invasive Bladder Cancer

Presented by Yair Lotan, MD

San Francisco, CA (UroToday.com) Dr. Yair Lotan presented on Genomic Insights and Biomarkers for Treatment Selection in Muscle-Invasive and Non-Muscle-Invasive Bladder Cancer. He discussed the role of markers in bladder cancer and how they add independent information that can impact patient care. Read More

ASCO GU 2018: Lessons Learned From New Guidelines and How They Have Changed Management of Muscle-Invasive Bladder Cancer

Presented by Jeff Holzbeierlein, MD, FACS

San Francisco, CA (UroToday.com) Dr. Holzbeierlein began his discussion on the new muscle-invasive bladder cancer (MIBC) guidelines,¹a collaborative multi-disciplinary effort led by Dr. Sam Chang that involved input from all the major organizations, including AUA, ASCO, ASTRO, and patient advocates. Read More

IBCG Newsletter Clinical Review Articles

State of the Evidence Review Articles

Promoting BCAN’s 2025 Walks to End Bladder Cancer: Join the Fight Against Bladder Cancer

December 12, 2024

Bladder cancer is one of the most common cancers in the United States, impacting approximately 83,000 Americans each year. It is a disease that shocks not only the individuals diagnosed but also their families, caregivers, and communities. For healthcare providers, medical researchers, and doctors, bladder cancer deserves significant attention due to its prevalence and the urgent need for better treatments and outcomes. Read More

IBCN 2024: Highlights

Written by Amanda Myers, MD, Urologic Oncology Fellow, University of Texas, MD Anderson Cancer Center, Houston, TX

December 12, 2024

The IBCN 2024 occurred in Bern, Switzerland, from September 19th to September 21st, 2024. The event featured a keynote lecture on Friday morning by Niko Beerenwinkel, Professor of Computational Biology ETH Zurich, on “Inferring Tumor Evolution from Single-Cell Data.” Dr. Beerenwinkel discussed the evolutionary process of cancer, which can be visualized through tumor phylogeny and cell lineage trees. Read More

IBCG Retreat 2024

Written by Kelly Bree, MD, and Niyati Lobo, MD

December 11, 2024

The annual International Bladder Cancer Group (IBCG) Retreat was held in Houston, Texas, from August 23-24, 2024. Co-chaired by Drs. Shilpa Gupta, Roger Li, and Patrick Hensley, the event brought together over 90 international bladder cancer clinicians, scientists, and patient advocates, with IBCG representation spanning five continents. Read More

Gem/Doce in 2024: What is Next?

Written by Vignesh Packiam, MD, Associate Professor, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ

August 22, 2024

Sequential intravesical gemcitabine and docetaxel (Gem/Doce) has been a notable advancement in the treatment of non-muscle invasive bladder cancer (NMIBC) since Michael O’Donnell developed this regimen in 2009.¹ Following its initial publication in 2015, Gem/Doce has continued to gain traction in the urologic oncology community for various challenging situations. Read More

Publications

Peer-Reviewed Journal Abstracts

Adjuvant Pembrolizumab versus Observation in Muscle-Invasive Urothelial Carcinoma

BACKGROUND: Muscle-invasive urothelial carcinoma is an aggressive disease with high rates of relapse. Whether pembrolizumab as adjuvant therapy would be effective in patients with high-risk muscle-invasive urothelial carcinoma after radical surgery is unknown. Read More

Intravesical rAd-IFNα/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin-Refractory or Relapsed Non-Muscle-Invasive Bladder Cancer: A Phase II Randomized Study.

Purpose Many patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are either refractory to bacillus Calmette-Guerin (BCG) treatment or may experience disease relapse. We assessed the efficacy and safety of recombinant adenovirus interferon alfa with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, for patients with high-grade (HG) BCG-refractory or relapsed NMIBC.

Clinical Outcomes in Patients with Panurothelial Carcinoma Treated with Radical Nephroureterectomy Following Cystectomy for Metachronous Recurrence

We report pathologic, functional, and oncologic outcomes in patients treated with radical nephroureterectomy following radical cystectomy.

We identified patients who underwent radical cystectomy then radical nephroureterectomy for metachronous urothelial recurrence at our institution between January 1995 and December 2014.

Clinical impact of postoperative loss in psoas major muscle and nutrition index after radical cystectomy for patients with urothelial carcinoma of the bladder

Although the significance of preoperative nutritional status has been investigated, there is no report regarding the relationship of their postoperative changes on outcomes in patients who underwent radical cystectomy for bladder cancer.

Press Releases

Official Announcements on Clinical Developments

PADCEV™ Plus Keytruda® Significantly Improves Survival for Patients with Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility

PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients with muscle-invasive bladder cancer
Positive EV-304 data, combined with the recent unprecedented results from the EV-303 trial, highlight the potential of this combination to become a new platinum-free standard of care in an earlier stage of bladder cancer
Results from the Phase 3 EV-304 trial will be presented at an upcoming medical meeting and discussed with global health authorities for potential regulatory filings

Reno, Nevada (UroToday.com) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced positive topline results from an interim analysis of the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) for PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor. This pivotal study is evaluating the combination as neoadjuvant and adjuvant treatment (before and after surgery) versus standard of care neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS), and overall survival (OS), a key secondary endpoint. Read More

CG Oncology Announces Nature Medicine Publication of Phase 1b Study Results Evaluating Cretostimogene Grenadenorepvec in Combination with Nivolumab in Muscle-Invasive Bladder Cancer

Phase 1b study results were published simultaneously in Nature Medicine and presented at the Society for Immunotherapy of Cancer 2024
Encouraging data adds to the body of evidence supporting potential use of cretostimogene as a backbone bladder-sparing therapeutic for bladder cancer

Reno, Nevada (UroToday.com) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, announced the publication in Nature Medicine of Phase 1b investigator-sponsored study results evaluating intravesical cretostimogene grenadenorepvec in combination with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab, in muscle-invasive bladder cancer (MIBC). The publication is now available online and will be in a future print edition of Nature Medicine. The results were also presented at the Society for Immunotherapy of Cancer (SITC) 2024 by Dr. Roger Li, M.D., urologic oncologist at Moffitt Cancer Center. Read More

Centers of Excellence

The Latest Research on Muscle Invasive Bladder Cancer

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