- Pfizer's (PFE, Financial) Phase 3 CREST trial of sasanlimab with BCG shows 32% reduction in disease-related events.
- Trial met primary endpoint, significantly improving event-free survival in high-risk NMIBC patients.
- Findings shared with global health authorities for potential regulatory filings.
Pfizer Inc. (PFE) has announced the successful completion of the pivotal Phase 3 CREST trial, investigating sasanlimab, an anti-PD-1 monoclonal antibody, in combination with Bacillus Calmette-Guérin (BCG) therapy in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The trial achieved its primary endpoint, with a statistically significant improvement in event-free survival (EFS) compared to BCG alone, marking a significant advancement in NMIBC treatment.
The results demonstrated a 32% reduction in the risk of disease-related events such as high-grade disease recurrence or progression when sasanlimab was combined with BCG. Patients receiving the combination therapy showed an EFS hazard ratio (HR) of 0.68, with a 95% confidence interval (CI) of 0.49 to 0.94, and a two-sided p-value of 0.019.
The Phase 3 findings, currently being presented at the 2025 American Urological Association Annual Meeting, highlight the combination's capability to redefine the treatment paradigm for high-risk NMIBC, potentially reducing the burden for patients who experience high recurrence rates with standard BCG treatment alone.
Sasanlimab was administered subcutaneously every four weeks in combination with BCG for induction and maintenance therapy. The trial's results have been shared with global health authorities to support future regulatory filings, further underscoring Pfizer's commitment to transforming cancer treatment.
The study also involved key secondary endpoints, showing consistent benefit for patients with higher-risk NMIBC, including an EFS HR of 0.63 for T1 disease and 0.53 for those with carcinoma in situ (CIS) disease. The probability of remaining event-free at 36 months was 82.1% with the sasanlimab combination versus 74.8% with BCG alone.
