Positive Phase III results for Pfizer’s sasanlimab

10 January 2025

US pharma giant Pfizer (NYSE: PFE) today announced positive top-line results from its pivotal Phase III CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (MAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

Pfizer noted that the study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance).

In PD-(L)1 blockade Pfizer’s most advanced focus has been on the SC MAb sasanlimab. Pfizer said it is planning to discuss the results with global health authorities to support potential regulatory filings for sasanlimab in this indication, adding that it will continue to evaluate the drug in combination with its antibody drug conjugate portfolio in advanced solid tumors.

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