Biopharmaceutical company Pfizer Inc (NYSE:PFE) on Friday announced positive topline results from its Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 inhibitor, in combination with Bacillus Calmette-Guérin (BCG) for high-risk non-muscle invasive bladder cancer (NMIBC).

The study met its primary endpoint of event-free survival, demonstrating a statistically significant improvement with the combination therapy compared to BCG alone. This represents a potential breakthrough in the treatment of high-risk NMIBC, where treatment options have remained largely unchanged for decades.

The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known safety profiles of both agents.

Pfizer plans to submit these results to health authorities to support potential regulatory filings.

Sasanlimab is also being investigated in combination with other Pfizer therapies.