Agasti 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).
Iziguli ezithole i-cemiplimab-rwlc zibe nokunyuka okuphawulekayo kwezibalo ku-OS ne-PFS uma ziqhathaniswa nalezo ezithole ukwelashwa ngamakhemikhali okusekelwe ku-platinum. Iziguli eziseqenjini le-cemiplimab-rwlc zine-median OS yezinyanga ezingu-22.1 (95 amaphesenti CI: 17.7, NE), uma kuqhathaniswa nezinyanga ezingu-14.3 (amaphesenti angu-95 CI: 11.7, 19.2) engalweni ye-chemotherapy (HR 0.68; 95 amaphesenti CI: 0.53 , 0.87, p=0.0022). Ingalo ye-cemiplimab-rwlc yayine-PFS emaphakathi yezinyanga ezingu-6.2 (4.5, 8.3) futhi ingalo ye-chemotherapy yayine-PFS emaphakathi yezinyanga ezingu-5.6 (4.5, 6.1) (HR 0.59; 95 amaphesenti CI: 0.49, 0.72, p0.0001). Emaqenjini e-cemiplimab-rwlc nawe-chemotherapy, izinga lokuphendula eliqinisekisiwe (ORR) nge-BICR ngalinye lalingamaphesenti angama-37 (amaphesenti angama-95 CI: 32, 42) namaphesenti angama-21 (amaphesenti angama-95 CI: 17, 25), ngokulandelana.
Ukungakhululeki kwemisipha namathambo, ukuqubuka, ukuphelelwa igazi, ukukhathala, ukuncipha kwesifiso sokudla, inyumoniya, nokukhwehlela kwakuyizehlakalo ezingezinhle ezazivame kakhulu (> 10%) nge-cemiplimab-rlwc njengesidakamizwa esisodwa kuSifundo 1624.
Umthamo ophakanyisiwe we-cemiplimab-rwlc wokwelashwa kwe-NSCLC ngu-350 mg njalo emavikini amathathu, ulawulwa ngomthambo imizuzu engama-30.
Inkomba: https://www.fda.gov/
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