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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Physician-Scientist Review Articles
State of the Evidence Review Articles
January 27, 2024

(UroToday.com) The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between January 25th and 27th was host to a urothelial carcinoma trials in progress poster session. 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).

January 26, 2024

(UroToday.com) 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 started his presentation with a case report of a 71 year old female who presented with gross hematuria and a CT scan showing a 3 cm bladder mass. A TURBT demonstrated T1 high grade urothelial carcinoma with CIS and with muscle in the specimen. A re-TURBT demonstrated only CIS. Dr. Meeks notes that in this situation the hospital has limited BCG available: there is an option to start BCG, but at only 1/3 the dose and you do not know if you can provide BCG through year 1. What do you recommend? Several options, which are all rational for this patient, include:

January 25, 2024
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. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $380.0 million. CG Oncology’s common stock is expected to begin trading on the Nasdaq Global Select Market on January 25, 2024 under the ticker symbol “CGON.” The offering is expected to close on January 29, 2024, subject to the satisfaction of customary closing conditions. In addition, CG Oncology has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.
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. 


December 4, 2023
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. These data will be featured today in a Late-Breaking Oral Podium Presentation (Abstract #LBA3396) by Mark D. Tyson, M.D., urologic oncologist at Mayo Clinic, at the 24 Annual Meeting of the Society of Urological Oncology (SUO) taking place November 28 – December 1, 2023, in Washington, DC.