Agusta 2021: The FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumours have high PD-L1 expression (Tumor Proportion Score [TPS] > 50 percent) whose tumours have high PD-L
Study 1624 (NCT03088540), a multicenter, randomised, open-label trial in 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation, or with metastatic NSCLC, was conducted to assess efficacy. Patients were given either cemiplimab-rwlc 350 mg intravenously every 3 weeks for up to 108 weeks or platinum-based chemotherapy. Per a blinded independent central review, the major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) (BICR).
Marasa lafiya da suka karɓi cemiplimab-rwlc sun sami ƙaruwa a cikin ƙididdiga a cikin OS da PFS idan aka kwatanta da waɗanda suka karɓi jiyya na tushen platinum. Marasa lafiya a cikin ƙungiyar cemiplimab-rwlc suna da OS na tsaka-tsaki na watanni 22.1 (95 bisa dari CI: 17.7, NE), idan aka kwatanta da watanni 14.3 (95 bisa dari CI: 11.7, 19.2) a cikin hannun chemotherapy (HR 0.68; 95 kashi CI: 0.53 , 0.87, p = 0.0022). Hannun cemiplimab-rwlc yana da matsakaicin PFS na watanni 6.2 (4.5, 8.3) kuma hannun chemotherapy yana da matsakaicin PFS na watanni 5.6 (4.5, 6.1) (HR 0.59; 95 kashi CI: 0.49, 0.72, p0.0001). A cikin rukunin cemiplimab-rwlc da chemotherapy, ƙimar amsawar gaba ɗaya (ORR) ta BICR shine kashi 37 (95 bisa dari CI: 32, 42) da kashi 21 (95 bisa dari CI: 17, 25), bi da bi.
Rashin jin daɗi na musculoskeletal, rash, anemia, gajiya, rage ci, ciwon huhu, da tari sune abubuwan da suka fi yawa (> 10%) tare da cemiplimab-rlwc azaman magani ɗaya a cikin Nazarin 1624.
Yawan shawarar cemiplimab-rwlc don NSCLC magani shine 350 MG kowane mako uku, ana gudanar da shi cikin mintuna 30.
Magana: https://www.fda.gov/
Duba cikakkun bayanai nan.
