CG Oncology Phase 3 Study – 75.5% Complete Response in BCG-Unresponsive Bladder Cancer

By Bobby Samwell • Monday, March 24 15:14 • Permanent Link

CG Oncology, Inc. (NASDAQ: CGON) has released encouraging data from its phase 3 study of cretostimogene monotherapy for high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS). The latest bond-003 data show that 83 out of 110 patients (75.5%) achieved a complete response (CR) at any time, with 46% of patients in CR at 12 months and 30 confirmed responses at 24 months.

The median duration of response (DOR) exceeds 28 months and is ongoing, demonstrating the durability of cretostimogene's response. Notably, there have been no grade 3 or greater treatment-related adverse events (TRAEs) reported, and 97.3% of patients completed all expected treatments, indicating favorable patient adherence and compliance.

Translational data presented at the 40th Annual European Association of Urology (EAU) Congress revealed that post-cretostimogene treatment close contact precautions are unnecessary, as the level of cretostimogene peaked immediately after instillation and was sustained locally for 4-5 days, with no systemic exposure observed.

Ambaw Bellete, President & Chief Operating Officer of CG Oncology, expressed gratitude to the patients and providers who participated in the study, emphasizing cretostimogene's potential to significantly impact the future of bladder cancer care. The company envisions a world where urologic cancer patients may benefit from their innovative immunotherapies to live with dignity and have an enhanced quality of life.

Cretostimogene grenadenorepvec is an investigational, intravesically delivered oncolytic immunotherapy candidate being evaluated in phase 3 clinical trials for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to BCG therapy. It is also being assessed in a phase 3 monotherapy clinical trial (PIVOT-006) for patients with intermediate-risk NMIBC and in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle-invasive bladder cancer. Following these announcements, the company's shares moved 4.9%, and are now trading at a price of $28.38. For more information, read the company's full 8-K submission here.

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