{"id":10828,"date":"2023-12-08T23:54:00","date_gmt":"2023-12-08T15:54:00","guid":{"rendered":"https:\/\/flcube.com\/?p=10828"},"modified":"2024-11-01T23:57:01","modified_gmt":"2024-11-01T15:57:01","slug":"pfizer-and-cstone-secure-nmpa-approval-for-sugemalimab-first-pd-l1-inhibitor-for-escc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=10828","title":{"rendered":"Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC"},"content":{"rendered":"\n

Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616<\/a>) 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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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<\/a><\/p>\n\n\n\n

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Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,188,856,863,18,309,15],"class_list":["post-10828","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-cstone-pharmaceuticals","tag-hkg-2616","tag-nyse-pfe","tag-pd-1-l1","tag-pfizer","tag-product-approvals"],"yoast_head":"\nPfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"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. 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