A Phase 3 Study of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)

  • Condition: Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
  • Study ID: NCT04452591
Active, not recruiting
Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Taylor Goodstein, MD
The 2026 American Urological Association annual meeting featured a non-invasive bladder cancer session and a presentation by Dr. Taylor Goodstein discussing immune microenvironment signatures of response to cretostimogene grenadenorepvec in BCG-unresponsive non-muscle invasive bladder cancer.
Presented by Vikram Narayan, MD
The 2026 SESAUA annual meeting featured a bladder cancer session and presentation by Dr. Vikram Narayan discussing topline results from BOND-003 cohort P assessing intravesical cretostimogene grenadenorepvec for treatment of high-risk, papillary only, BCG-unresponsive non-muscle invasive bladder cancer.
Presented by Press Release
  • Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 Disease in BOND-003 Cohort P
  • CORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR and favorable safety with optimized administration
  • Robust clinical pipeline that spans multiple late-stage studies across intermediate- and high-risk NMIBC
Presented by Mark Tyson, MD, MPH
At the 2025 SUO Annual Meeting, Dr. Mark Tyson presented the topline data from BOND-003 Cohort P evaluating intravesical cretostimogene grenadenorepvec in a population of patients with high-risk, papillary-only, BCG-unresponsive NMIBC.
Presented by Mark Tyson II, MD, MPH
The 2025 Western Section AUA annual meeting featured a urothelial carcinoma session and a presentation by Dr. Mark Tyson discussing the first results from BOND-003 Cohort P, a multi-national, single-arm study of intravesical cretostimogene grenadenorepvec for treatment of high-risk, papillary-only, BCG-unresponsive non-muscle invasive bladder cancer. Patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer have limited treatment options.
Presented by Colin Dinney, MD
Colin Dinney, MD, discussed updates to the BOND-003 Cohort P trial. Patients presenting with high risk BCG-unresponsive non muscle invasive bladder cancer have limited treatment options.
Presented by Mark Tyson, MD, MPH
Mark Tyson, MD, MPH, presented BOND-003 Cohort P, a multinational, single arm study of intravesical Cretostimogene Grenadenorepvec for the treatment of BCG-unresponsive, high-risk, papillary-only non-muscle invasive bladder cancer (NMIBC).
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 cretostimogene grenadenorepvec monotherapy data was presented at the Practice-Changing, Paradigm-Shifting Clinical Trials in Urology Plenary Session at the 2025 American Urological Association (AUA) Annual Meeting, in Las Vegas, Nevada.
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.
Presented by Sia Daneshmand, MD
The 2025 European Association of Urology (EAU) Annual Meeting held in Madrid, Spain between March 21st and 24th 2025, was host to the Abstract Session 05: On the Horizon: Ongoing Trials in Urology. Dr. Sia Daneshmand presented A0083: Trial in Progress: BOND-003 Cohort P- A Multi-national, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive 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 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 Mark Tyson II, MD, MPH
The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Mark Tyson discussing BOND-003 Cohort P, a multi-national, single-arm study of intravesical cretostimogene grenadenorepvec for the treatment of high-risk, papillary only, BCG-unresponsive non muscle invasive bladder cancer (NMIBC).
Presented by Neema Navai, MD
The 2024 South Central AUA annual meeting included a session on bladder cancer, featuring a presentation by Dr. Neema Navai discussing emerging treatments for non muscle invasive bladder cancer (NMIBC). From a historical perspective, Dr. Navai notes that Dr. Raymond Pearl performed a case control autopsy study (controlling for sex, age, and race) in 1929 assessing the rate of tuberculosis, finding that in cancer patients it was 6.6% compared to 16.3% in non-cancer patients. 
Presented by Colin Dinney, MD
The 2024 IBCN annual meeting included a session on novel therapies and outcome measures in clinical trials, featuring a presentation by Dr. Colin Dinney discussing results from a comprehensive analysis from BOND-003 assessing translational correlates using urinary genomic disease burden to assess cretostimogene grenadenorepvec.
Presented by Mark Tyson II, MD, MPH
The 2024 American Urological Association (AUA) annual meeting featured a session on bladder cancer trials in progress, and a presentation by Dr. Mark Tyson discussing BOND-003- Cohort P, a multi-national, single-arm study of intravesical cretostimogene grenadenorepvec for the treatment of high risk, papillary only, BCG-unresponsive non-muscle invasive bladder cancer.
Presented by Mark Tyson II, MD, MPH
The 2024 American Urological Association (AUA) annual meeting featured a plenary session, and a presentation by Dr. Mark Tyson discussing results from BOND-003, a phase 3, single-arm study assessing intravesical cretostimogene grenadenorepvec for the treatment of high risk, BCG-unresponsive non-muscle invasive bladder cancer.
Press Releases
Official Announcements on Clinical Developments
  • Robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monotherapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) treatment
  • 90% of 12-month responders remained disease free at 24 Months
  • Safety profile remains consistent
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, today announced updated data on BOND-003 Cohort C showing 12 additional patients with high risk non-muscle invasive bladder cancer (HR NMIBC) were in complete response (CR) at 24 months.