<a href="https://www.fiercebiotech.com/biotech/next-gen-io-race-nsclc-biontechbms-and-pfizer-split-overall-survival-scheme" hreflang="en">In next-gen IO race in NSCLC, BioNTech/BMS and Pfizer are divided on overall survival approach</a>
In the competitive landscape of next-generation immuno-oncology for non-small cell lung cancer (NSCLC), BioNTech and Bristol Myers Squibb (BMS) have opted to prioritize progression-free survival (PFS) as the primary endpoint in their clinical trials, while Pfizer maintains overall survival (OS) as a key focus, reflecting differing strategies in their race to establish effective therapies. This divergence highlights the ongoing debate about the importance of OS versus PFS in regulatory approval and clinical acceptance, particularly in light of established treatments like Merck's Keytruda.
For a professional tracking healthtech and biotech, the key insight is the strategic divergence between BioNTech/BMS and Pfizer in their approach to clinical trial endpoints for PD-(L)1xVEGF bispecific antibodies in NSCLC. BioNTech/BMS's focus on progression-free survival (PFS) as the primary endpoint allows for faster regulatory engagement, which could accelerate market entry, while Pfizer maintains overall survival (OS) as a co-primary endpoint to strengthen regulatory and clinical confidence. This highlights a potential investment and collaboration opportunity in companies that can balance innovative trial designs with regulatory expectations to expedite approval processes.