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Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin (CORE-001)

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos

A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

  • Condition: Non Muscle Invasive Bladder Cancer
  • Study ID: NCT04387461
ACTIVE, NOT RECRUITING
Physician-Scientist Review Articles
State of the Evidence Review Articles
Written by Zachary Klaassen, MD, MSc, Wellstar MCG Health Georgia Cancer Center Augusta, Georgia, USA
December 12, 2023

Bladder cancer remains the sixth most commonly diagnosed cancer in the United States, with an estimated 82,290 incident cases in 2023.1 Because of the persistent recurrence risk of NMIBC in a highly comorbid population, there has been an FDA-led drive towards developing novel treatment options for these patients. The following article will highlight recent advances in this disease space with a specific focus on the oncolytic adenovirus agent cretostimogene grenadenorepvec, and the registration trial in intermediate risk non-muscle invasive bladder cancer (NMIBC), PIVOT-006. 

 

Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Sharada Mokkapati
 The 2025 EAU annual meeting featured a non muscle invasive bladder cancer session and a presentation by Dr. Sharada Mokkapati discussing translational correlates using urinary genomic disease burden to assess cretostimogene grenadenorepvec in the BOND-003 and CORE-001 trials. Urinary genomic disease burden profiling uses next-generation sequencing to identify mutations and DNA alterations associated with bladder cancer. It has shown in prior series to be associated with bladder cancer recurrences and responses to therapy. Cretostimogene grenadenorepvec is an oncolytic immunotherapy with a dual mechanism of action.
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 that a late-breaking abstract on BOND-003 Cohort C, as well as three posters highlighting cretostimogene grenadenorepvec, will be presented at the 40th Annual European Association of Urology (EAU) Congress
Presented by Roger Li, MD
The 2024 ASCO annual meeting featured a presentation by Dr. Roger Li discussing the final results of CORE-001, a phase-2, single arm study of cretostimogene grenadenorepvec in combination with pembrolizumab in patients with BCG-unresponsive, non-muscle invasive bladder cancer with CIS. 
Reno, Nevada (UroToday.com) -- CG Oncology, Inc. a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced final results from the Phase 2 CORE-001 clinical trial of its oncolytic immunotherapy candidate, cretostimogene, in combination with pembrolizumab for the treatment of BCG-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) with Carcinoma in Situ (CIS). The data will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting from May 31-June 4, in Chicago, IL.L.
Presented by Roger Li, MD
(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to a non-invasive bladder cancer podium session. Dr. Roger Li presented the results of CORE1, a phase 2 single arm study of CG0070 combined with pembrolizumab in patients with non-muscle invasive bladder cancer unresponsive to Bacillus Calmette-Guerin (BCG).
Publications
Peer-Reviewed Journal Abstracts
– Final positive CORE-001 safety and efficacy findings were published simultaneously online by Nature Medicine and featured at ASCO 2024 –
– 54% complete response (CR) rate in the intention-to-treat population at 24-month landmark and meets primary endpoint of the phase 2 study
Press Releases
Official Announcements on Clinical Developments
Cretostimogene grenadenorepvec is a serotype-5 oncolytic adenovirus designed to selectively replicate in cancer cells with retinoblastoma pathway alterations, previously tested as monotherapy in bacillus Calmette–Guérin (BCG)-experienced non-muscle-invasive bladder cancer.