First Patient Treated in Phase 3 Cretostimogene Trial for Intermediate-risk NMIBC

CG Oncology, a biopharmaceutical firm, has initiated a Phase 3 clinical trial, PIVOT-006, for cretostimogene, an oncolytic immunotherapy treatment for intermediate-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients. The first participant has received the treatment following the transurethral resection of the bladder tumor (TURBT). The study aims to address the limited options and frequent recurrences faced by these patients, with a focus on advancing cretostimogene as a potential backbone therapy.

The trial is designed as an open-label, two-arm study, with up to 426 patients enrolled. One group will receive cretostimogene post-TURBT, while the other will only receive the standard care. The treatment involves an initial course of six weekly doses, followed by a maintenance course with additional doses at specific intervals. The primary goal is to evaluate overall recurrence-free survival (RFS), with secondary goals including RFS at 12 and 24 months and progression-free survival (PFS).

Cretostimogene is also being tested in other trials for different stages of bladder cancer, including a Phase 3 trial (BOND-003) for BCG-unresponsive NMIBC, a Phase 2 trial (CORE-001) in combination with pembrolizumab, and an investigator-sponsored trial with nivolumab for muscle invasive bladder cancer.

Bladder cancer is a prevalent disease, with over 83,000 new cases expected in 2024, of which NMIBC accounts for about 75%. CG Oncology is dedicated to developing bladder-sparing therapies to improve patients' quality of life.

The company's vision is to provide innovative immunotherapies to urologic cancer patients, enhancing their dignity and life quality.