US-based Pfizer Inc. (NYSE: PFE) has reported positive topline results from its pivotal Phase III CREST study. The study evaluated 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). The results showed that sasanlimab in combination with BCG (induction and maintenance) achieved a clinically meaningful and statistically significant improvement in event-free survival (EFS) compared to BCG alone (induction and maintenance), meeting the primary endpoint of the study.
Study Details and Efficacy
Sasanlimab, administered via a once every four weeks subcutaneous injection using a prefilled syringe (2mL), demonstrated significant clinical efficacy in earlier studies involving advanced solid tumors and advanced urothelial carcinoma. The positive results from the Phase III CREST study further validate the potential of sasanlimab as a valuable addition to the treatment paradigm for high-risk NMIBC, particularly in patients who are BCG-naïve.
Future Prospects
The successful outcome of the Phase III CREST study is a significant milestone for Pfizer’s oncology pipeline. Sasanlimab’s ability to improve event-free survival when used in combination with BCG highlights its potential to become a new standard of care for patients with high-risk NMIBC. Pfizer is expected to continue advancing the clinical development of sasanlimab, with the goal of bringing this innovative therapy to market and improving patient outcomes in bladder cancer.-Fineline Info & Tech
