Pfizer announces Phase 3 CREST trial met primary endpoint of EFS

Pfizer (PFE) announced results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin as induction therapy with or without maintenance in patients with BCG-naive, high-risk non-muscle invasive bladder cancer, NMIBC. The trial 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 as compared to BCG alone: Hazard Ratio of 0.68; 95% Confidence Interval, 0.49-0.94; 2-sided p=0.019; median EFS not yet reached. These findings show a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression, with the sasanlimab combination regimen as compared with SOC treatment alone. Pre-specified subgroup analyses for patients harboring higher risk disease showed consistent benefit with EFS HR of 0.63 for T1 disease, and EFS HR 0.53 for those with CIS disease.