CG Oncology Publishes CORE-001 Study Results on Cretostimogene Grenadenorepvec with Pembrolizumab in Nature Medicine

CG Oncology, Inc. (NASDAQ: CGON), a biopharmaceutical company specializing in advanced bladder cancer treatments, has announced the publication of the final results from its CORE-001 Phase 2 trial in Nature Medicine. The study investigates the efficacy of combining cretostimogene with pembrolizumab for patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC). These findings were also featured at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024.

Impressive Results in Phase 2 Trial:

The CORE-001 trial showed a 54% complete response (CR) rate in the intention-to-treat (ITT) population at the 24-month benchmark, reaching the primary endpoint. As of the data cutoff on February 5, 2024, the trial had previously reported a 57% CR rate at 12 months and an 83% CR rate at any time. The data further revealed that 95% of patients who achieved CR at 12 months maintained it for an additional year. The median duration of response (DoR) has not yet been reached but exceeds 21 months. Kaplan-Meier estimates indicated a 77.3% CR rate at 12 months and 69.6% at 24 months.

Safety and Efficacy:

CG Oncology’s Chief Medical Officer, Dr. Vijay Kasturi, highlighted that the published results underscore the potential of cretostimogene as a bladder-sparing therapy. The trial demonstrated compelling safety and efficacy, exhibiting a class-leading CR and DoR when compared to existing FDA-approved therapies and other investigational candidates.

Expert Endorsement:

Dr. Roger Li, a principal investigator on both the BOND-003 Phase 3 and CORE-001 Phase 2 trials, expressed satisfaction with the outcomes. He emphasized the innovative mechanism of action of cretostimogene, which not only kills tumor cells directly but also stimulates an anti-tumor immune response. Dr. Li believes that cretostimogene could become a foundational element in various bladder cancer treatment strategies.

Progression-Free and Cystectomy-Free Survival:

The trial reported a 100% progression-free survival (PFS) rate at 24 months, with no patients progressing to muscle-invasive cancer or metastatic disease. Additionally, the cystectomy-free survival (CFS) rate was 80%, and for patients in CR, it was 100%.

Adverse Events:

The treatment-related adverse events (TRAEs) observed were consistent with those expected from the individual agents used and did not show any synergistic toxicity.

Collaboration and Designations:

The Phase 2 CORE-001 trial was conducted in collaboration with Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. The combination therapy has received FDA Breakthrough Therapy Designation, while the monotherapy also received Fast Track and Breakthrough Therapy Designations for BCG-Unresponsive, high-risk NMIBC with carcinoma in situ (CIS). 

Future Prospects:

CG Oncology recently presented data from the Phase 3 BOND-003 trial at the American Urological Association Annual Meeting 2024, showing a 75.2% CR rate and durable responses over 12 months. The company anticipates topline data from BOND-003 by the end of 2024 and is on track for a regulatory approval submission.

About Cretostimogene Grenadenorepvec

Cretostimogene is an investigational oncolytic immunotherapy delivered intravesically and is currently being evaluated in the Phase 3 BOND-003 trial for high-risk NMIBC patients unresponsive to BCG therapy. It is also under investigation in the PIVOT-006 trial for intermediate-risk NMIBC patients, and in a trial combining it with nivolumab for muscle-invasive bladder cancer.

About CG Oncology

CG Oncology is at the forefront of developing groundbreaking bladder cancer therapies. The company aims to improve the quality of life for urologic cancer patients through innovative immunotherapies.

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