Pfizer shows significant survival improvement with new cancer therapy

On April 26, 2025, in New York, Pfizer Inc. revealed the outcomes of the Phase 3 CREST trial for sasanlimab, an investigational anti-PD-1 monoclonal antibody. This trial focused on its efficacy combined with standard Bacillus Calmette-Guérin (BCG) therapy for patients experiencing BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The results showed that the combination met its primary endpoint of event-free survival (EFS), demonstrating a 32% reduction in the risk of disease-related events such as high-grade disease recurrence or progression compared to BCG treatment alone. The hazard ratio was reported as 0.68 with statistical significance indicated by a p-value of 0.019. Furthermore, while the combination improved EFS significantly, the combination regimen with sasanlimab and BCG induction only did not prolong EFS when compared to BCG alone; this outcome underscored the importance of BCG maintenance therapy. The trial also revealed a high complete response (CR) rate of 89.8% with the combination therapy versus 85.2% for BCG alone. However, it should be noted that interim analysis for overall survival showed no significant differences between the treatment arms. These findings highlight both the potential and need for new treatment approaches in bladder cancer, which is the ninth most common cancer worldwide and results in approximately 220,000 deaths annually. With this trial, Pfizer aims to revolutionize the treatment landscape for high-risk NMIBC patients and looks forward to discussions with regulatory authorities regarding potential approvals for sasanlimab.