Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National Medical Products Administration (NMPA) for sugemalimab, a treatment for first-line irresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluorouracil and platinum. This approval marks sugemalimab as the first programmed death-ligand 1 (PD-L1) inhibitor to receive global recognition for this specific indication.
The approval is supported by data from the GEMSTONE-304 trial, which achieved its pre-defined dual endpoints. Results indicated that the combination therapy significantly enhanced progression-free survival (mPFS: 6.2 months vs. 5.4 months) and overall survival (mOS: 15.3 months vs. 11.5 months) among patients with first-line irresectable locally advanced, recurrent, or metastatic ESCC. Benefit trends were consistent across all pre-set subgroups and the overall population. The objective response rate (ORR) assessed by blinded independent central review (BICR) was 60.1% compared to 45.2%, with a duration of response (DoR) of 6.0 months versus 4.5 months.
Sugemalimab was initially approved in China in December 2021 and has since received additional approvals for use in first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in combination with pemetrexed and carboplatin, as well as for unresectable stage III NSCLC post-chemotherapy/radiotherapy. The drug is also awaiting regulatory decisions in the UK and European Union for first-line NSCLC in conjunction with chemotherapy. Pfizer and CStone’s collaboration on this product began in 2020, focusing on its development and commercialization in mainland China.- Flcube.com
