Nuwamba 2022: Haɗuwa da cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) da kuma tushen ilimin chemotherapy na platinum ga manya marasa lafiya tare da ci-gaba marasa ciwon huhu na huhu (NSCLC) ba tare da EGFR, ALK, ko ROS1 rashin daidaituwa ba an yarda da su ta Abinci da Drug Gudanarwa.
Nazarin 16113 (NCT03409614), bazuwar, cibiyar sadarwa mai yawa, kasa da kasa, makafi biyu, gwaji mai sarrafawa a cikin marasa lafiya 466 tare da ci gaba na NSCLC wanda ba a taɓa yin maganin tsarin ba, ya kimanta tasiri a wannan batun. Cemiplimab-rwlc da ƙwayar cuta ta platinum a kowane mako 3 don hawan keke na 4, sannan cemiplimab-rwlc da chemotherapy biye da su, ko placebo tare da chemotherapy na tushen platinum kowane mako 3 don hawan keke 4, sannan placebo da kula da chemotherapy, sune zaɓuɓɓukan magani guda biyu. miƙa wa marasa lafiya waɗanda aka ba da izini (2: 1).
Gabaɗaya rayuwa shine ma'aunin sakamako na farko (OS). Rayuwa marar ci gaba (PFS) da ƙimar amsa gabaɗaya (ORR), kamar yadda aka ƙaddara ta hanyar nazari na tsakiya mai zaman kansa mai zaman kansa, ƙarin matakan sakamako ne na inganci (BICR).
Idan aka kwatanta da placebo da chemotherapy, cemiplimab-rwlc da platinum-tushen chemotherapy sun nuna mahimmancin ƙididdiga da ingantaccen ingantaccen asibiti a cikin rayuwa gabaɗaya (OS) (haɗarin haɗari [HR] na 0.71 [95% CI: 0.53, 0.93], mai gefe biyu. p-darajar = 0.0140). A cikin cemiplimab-rwlc da chemotherapy hannu, matsakaicin OS shine watanni 21.9 (95% CI: 15.5, ba mai ƙima ba), idan aka kwatanta da watanni 13.0 (95% CI: 11.9, 16.1) a cikin placebo da ƙungiyar chemotherapy. A cikin cemiplimab-rwlc da chemotherapy hannu, matsakaicin PFS ta BICR shine watanni 8.2 (95% CI: 6.4, 9.3), yayin da yake watanni 5.0 (95% CI: 4.3, 6.2) a cikin placebo tare da hannun chemotherapy (HR 0.56). ; 95% CI: 0.44, 0.70, p0.0001). Tabbatar da ORR a kowane BICR don jiyya biyu shine 43% (95% CI: 38, 49) da 23% (95% CI: 16, 30).
Alopecia, ciwon musculoskeletal, tashin zuciya, gajiya, ciwon neuropathy na gefe, da rage cin abinci shine mafi yawan sakamako masu illa (15%).
350 MG IV kowane mako uku shine shawarar da aka ba da shawarar na cemiplimab-rwlc. Don bayanin adadin shawarar da aka ba da shawarar, kamar yadda ya cancanta, duba bayanin da aka tsara don magungunan da aka yi amfani da su tare da cemiplimab-rwlc.
