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PIVOT-006: A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

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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. 

 

A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

  • Condition:Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Non Muscle Invasive Bladder Cancer
  • Study ID: NCT06111235
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Articles and Abstracts
– First Patient Dosed in Expanded Access Program and Enrollment Ongoing –

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 it has initiated an Expanded Access Program (EAP) for cretostimogene grenadenorepvec in the U.S. for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guerin (BCG) and meet certain program eligibility criteria. The first patient has been dosed in the EAP and enrollment in the study is ongoing.
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.
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 afflicted with bladder cancer, announced the pricing of its upsized initial public offering of 20,000,000 shares of its common stock at an initial public offering price of $19.00 per share. All of the shares are being offered by CG Oncology.
Reno, Nevada (UroToday.com) -- CG Oncology, Inc. announced that Phase 3 monotherapy data from the BOND-003 clinical trial evaluating the efficacy and safety of cretostimogene grenadenorepvec in patients with high-risk NonMuscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG), showed that 75.7% of evaluable patients achieved a complete response (CR) at any time, as of the cutoff date of October 5, 2023.
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Robert S. Svatek, MD

Dr. Robert Svatek presented the PIVOT-006 trial, a phase 3, randomized study of cretostimogene grenadenorepvec (CG) versus observation for the treatment of intermediate risk non-muscle invasive bladder cancer (NMIBC) following transurethral resection of bladder tumor (TURBT).

Presented by Joshua J Meeks, MD, PhD
The 2024 GU ASCO annual meeting featured a session on the shortage of drugs for urothelial carcinoma and a presentation by Dr. Josh Meeks discussing what is on the horizon to replace BCG.  Dr. Meeks then discussed the BCG shortage timeline and production challenges. This started in 2012 with the FDA temporarily stopping the Sanofi Pasteur factory due to manufacturing and sterility issues.