CG Oncology, a clinical-stage biopharmaceutical company, has announced the final positive results from their Phase 2 CORE-001 study evaluating the combination therapy of cretostimogene grenadenorepvec and pembrolizumab in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC). The findings are set to be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting.
The Phase 2 CORE-001 study focused on assessing the safety and efficacy of cretostimogene grenadenorepvec, a novel oncolytic immunotherapy, in combination with pembrolizumab, an anti-PD-1 therapy. BCG-unresponsive high-risk NMIBC represents a particularly challenging subgroup of bladder cancer patients, often necessitating radical cystectomy due to the limited efficacy of existing therapeutic options.
Clinical Findings’
CG Oncology reported that the combination therapy demonstrated substantial antitumor activity and an acceptable safety profile. The study enrolled patients who had previously been treated with Bacillus Calmette-Guerin (BCG) therapy and had relapsed or shown persistence of high-risk NMIBC.
According to the study results:
- The overall response rate (ORR) was significantly higher compared to historical controls of pembrolizumab alone.
- A significant proportion of patients achieved a complete response (CR), indicating the absence of detectable cancer.
- The combination therapy was generally well-tolerated, with adverse events consistent with the known profiles of each individual component.
Significance’
These findings are significant for several reasons. Firstly, cretostimogene grenadenorepvec represents a new class of oncolytic viruses designed to selectively target and destroy cancer cells while stimulating an anti-tumor immune response. When combined with pembrolizumab, which blocks the PD-1 pathway thereby enhancing the body’s immune response against cancer, the resultant therapy addresses a critical need for more effective treatments for patients with BCG-unresponsive high-risk NMIBC.
Furthermore, the combination could potentially offer patients a non-surgical alternative to radical cystectomy, thereby preserving the bladder and maintaining a better quality of life.
Next Steps’
CG Oncology plans to further validate these results in additional trials and explore regulatory approval pathways. The positive data from the Phase 2 CORE-001 study provide a strong foundation for pivotal Phase 3 trials, which are necessary to confirm these findings in a larger patient population.
Overall, the promising results from this innovative combination therapy may pave the way for new treatment protocols and offer hope to patients facing limited options in managing their high-risk NMIBC.
Conclusion’
The presentation of these final Phase 2 results at the ASCO 2024 Annual Meeting will be a significant milestone for CG Oncology and the broader medical community. If successful in subsequent trials, this novel combination therapy could revolutionize the treatment landscape for BCG-unresponsive high-risk NMIBC, offering new hope and improved outcomes for patients suffering from this challenging condition.
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