CG Oncology Completes Enrollment in PIVOT-006

Core Insights - CG Oncology has completed enrollment in its Phase 3 PIVOT-006 study, which compares adjuvant intravesical cretostimogene grenadenorepvec to surveillance in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) [1][2] - The study has enrolled over 360 patients across more than 90 sites, indicating a strong interest and urgent need for new treatment options in this patient population [2][3] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies for bladder cancer, aiming to improve the quality of life for patients [5] - The company is dedicated to addressing high unmet needs in bladder cancer treatment, particularly in intermediate-risk and high-risk NMIBC [2][4] Study Details - PIVOT-006 is a randomized, open-label trial where participants receive either cretostimogene instillations or surveillance after standard tumor removal [3] - The treatment regimen includes weekly instillations for 6 weeks, followed by weekly treatments for 3 weeks every 3 months for one year [3] Treatment Potential - Cretostimogene is an investigational oncolytic immunotherapy that selectively lyses tumor cells while activating an anti-cancer immune response, representing a novel treatment paradigm for NMIBC [2][4] - The investigational therapy has been studied in over 400 patients and is part of a broader clinical development program that includes trials for both high-risk and intermediate-risk NMIBC [4]