Pfizer bids for a seat at the subQ table

After last year's approvals of Roche's Tecentriq Hybreza and Bristol Myers Squibb's Opdivo Qvantig, Pfizer is trying to get in on the subcutaneous PD-1 act. The company last week toplined a phase 3 success for its SC contender sasanlimab in the Crest study in non-muscle invasive bladder cancer (NMIBC), and said it would move to discuss the data with regulators. Crest is the only Pfizer-sponsored pivotal study of sasanlimab, and is said to have met its primary endpoint, yielding a clinically meaningful and statistically significant event-free survival improvement for sasanlimab plus BCG versus BCG alone; no numbers were revealed. While Merck & Co's Keytruda, Ferring's Adstiladrin and ImmunityBio's Anktiva are all approved for BCG-unresponsive NMIBC, Crest enrolled only BCG-naive patients. Until now perhaps the most relevant data for sasanlimab have come from a phase 1 open-label study showing a 21% ORR in metastatic urothelial carcinoma. However impressive the Crest data turn out to be Pfizer has its work cut out; SC versions of Tecentriq and Opdivo are available across all their current IV indications, and Keytruda might soon be too, but because sasanlimab is a new molecule rather than a reformulation there is no short cut to an indication-wide approval.