CG Oncology disclosed topline results from its BOND‑003 Cohort P phase 3 study of cretostimogene grenadenorepvec in patients with BCG‑unresponsive papillary‑only non‑muscle invasive bladder cancer. The data, presented at the Society of Urologic Oncology meeting on December 5 2025 and based on a September 1 2025 cut‑off, show a high‑grade event‑free survival of 95.7 % at 3 months, 84.6 % at 6 months, and 80.4 % at 9 months. No grade 3 or higher treatment‑related adverse events, no deaths, and no progression to muscle‑invasive disease or need for radical cystectomy were reported among the 56 patients enrolled across 35 U.S. and Japanese sites.
The company also released first results from CORE‑008 Cohort A, a phase 2 trial in high‑risk, BCG‑naïve carcinoma in situ patients. The overall complete‑response rate at any time was 83.7 % (41 of 49 patients). Within the first 24‑hour cohort, the CR rate was 79.2 %, rising to 88.0 % in the optimized two‑step cohort. No serious adverse events, treatment discontinuations, or progression to invasive disease were observed, underscoring the drug’s safety profile in both patient populations.
These data reinforce cretostimogene’s durability advantage and support its positioning as a backbone therapy across the NMIBC spectrum. The strong efficacy and safety signals bolster the company’s Fast Track and Breakthrough Therapy designations and provide compelling evidence for the FDA’s accelerated review pathway. CG Oncology’s rolling BLA submission, expected to be completed in 2026, could be accelerated by these results, potentially bringing the product closer to market approval and commercial launch. The findings also address the unmet need created by the ongoing BCG shortage and the limitations of current standard therapy.
Dr. Trinity J. Bivalacqua, a urologic oncologist at the University of Pennsylvania, said, “New data from BOND‑003 Cohort P and CORE‑008 Cohort A add to a growing body of evidence demonstrating cretostimogene’s potential to become a backbone treatment across the NMIBC spectrum, if approved.” CG Oncology’s leadership echoed this optimism, highlighting the dual mechanism of action—direct oncolytic cell killing combined with GM‑CSF‑mediated immune activation—as a key differentiator in a crowded therapeutic landscape.
The results also signal a strategic advantage in a market where BCG‑unresponsive and BCG‑naïve patients represent a sizable, underserved cohort. By demonstrating high response rates and a favorable safety profile, CG Oncology positions cretostimogene to capture a significant share of the bladder‑sparing treatment market, potentially reshaping standard care pathways and creating new revenue opportunities as the company advances toward regulatory approval.
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