Noyabr 2022: The combination of cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) and platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 abnormalities has been approved by the Food and Drug Administration.
16113 (NCT03409614) tadqiqoti, randomizatsiyalangan, ko'p markazli, xalqaro, ikki tomonlama ko'r, faol nazorat ostida bo'lgan, ilgari tizimli davolanishdan o'tmagan 466 nafar NSCLC bilan og'rigan bemorlarda bu boradagi samaradorlik baholandi. Cemiplimab-rwlc plus platinaga asoslangan kimyoterapiya har 3 haftada 4 sikl uchun, keyin semiplimab-rwlc va parvarishlash kimyoterapiyasi yoki platsebo va platina asosidagi kimyoterapiya har 3 haftada 4 sikl davomida, so'ngra platsebo va parvarishlash kimyoterapiyasi ikkita davolash usuli edi. tasodifiy tayinlangan bemorlarga taklif qilingan (2: 1).
Overall survival was the primary efficacy outcome measurement (OS). Progression-free survival (PFS) and overall response rate (ORR), as determined by a blinded independent central review, were additional efficacy outcome measures (BICR).
Platsebo plyus kimyoterapiya bilan solishtirganda, cemiplimab-rwlc plus platina asosidagi kimyoterapiya umumiy omon qolish (OS)da statistik jihatdan muhim va klinik jihatdan sezilarli yaxshilanishni ko'rsatdi (xavf darajasi [HR] 0.71 [95% CI: 0.53, 0.93], ikki tomonlama p-qiymati = 0.0140). Cemiplimab-rwlc plus kimyoterapiya guruhida o'rtacha OS platsebo va kimyoterapiya guruhidagi 21.9 oy (95% CI: 15.5, 13.0) bilan solishtirganda 95 oyni (11.9% CI: 16.1, baholanmaydi) tashkil etdi. Cemiplimab-rwlc plyus kimyoterapiya guruhida BICR uchun o'rtacha PFS 8.2 oyni (95% CI: 6.4, 9.3), platsebo va kimyoterapiya qo'lida (HR 5.0) 95 oyni (4.3% CI: 6.2, 0.56) tashkil etdi. 95% CI: 0.44, 0.70, p0.0001). Ikki muolaja uchun BICR uchun tasdiqlangan ORR 43% (95% CI: 38, 49) va 23% (95% CI: 16, 30) ni tashkil etdi.
Alopesiya, mushak-skelet tizimining og'rig'i, ko'ngil aynishi, charchoq, periferik neyropatiya va ishtahaning pasayishi eng ko'p uchraydigan nojo'ya ta'sirlar (15%) edi.
350 mg IV har uch haftada tavsiya etilgan semiplimab-rwlc dozasi. Tavsiya etilgan dozalar haqida ma'lumot olish uchun, kerak bo'lganda, cemiplimab-rwlc bilan birgalikda ishlatiladigan dorilar uchun retsept bo'yicha ma'lumotga qarang.
