August 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).
Bukaannada qaatay cemiplimab-rwlc waxay lahaayeen tirokoob aad u kordhay OS iyo PFS marka la barbar dhigo kuwa helay kiimoterabiga ku salaysan platinum. Bukaannada kooxda cemiplimab-rwlc waxay lahaayeen OS dhexdhexaad ah bilaha 22.1 (95 boqolkiiba CI: 17.7, NE), marka la barbar dhigo bilaha 14.3 (95 boqolkiiba CI: 11.7, 19.2) ee cududda kemotherabi (HR 0.68; 95 boqolkiiba CI: 0.53) , 0.87, p=0.0022). Cududda cemiplimab-rwlc waxay lahayd PFS dhexdhexaad ah oo ah 6.2 bilood (4.5, 8.3) iyo cududda kiimoterabiga waxay lahayd PFS dhexdhexaad ah 5.6 bilood (4.5, 6.1) (HR 0.59; 95 boqolkiiba CI: 0.49, 0.72, p0.0001). Kooxaha cemiplimab-rwlc iyo kiimoterabiga, heerka jawaabta guud ee la xaqiijiyay (ORR) halkii BICR waxay ahayd 37 boqolkiiba (95 boqolkiiba CI: 32, 42) iyo 21 boqolkiiba (95 boqolkiiba CI: 17, 25), siday u kala horreeyaan.
Raaxo la'aanta muruqyada, finan, dhiig-yaraan, daal, rabitaanka cuntada oo yaraada, oof-wareenka, iyo qufaca ayaa ahaa dhacdooyinka xun ee ugu badan (> 10%) oo leh cemiplimab-rlwc oo ah hal daawo oo ku jirta Daraasadda 1624.
Qiyaasta la soo jeediyay ee cemiplimab-rwlc ee daawaynta NSCLC waa 350 mg saddexdii toddobaadba mar, oo xididka laga siiyo 30 daqiiqo.
Tixraac: https://www.fda.gov/
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