Avgust 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).
Cemiplimab-rwlc olgan bemorlarda platina asosli kimyoterapiya olganlarga qaraganda OS va PFS ko'rsatkichlari statistik jihatdan sezilarli darajada oshgan. Cemiplimab-rwlc guruhidagi bemorlar 22.1 oylik o'rtacha operatsion tizimga ega edi (95 % CI: 17.7, SH), kimyoterapiya qo'lida 14.3 oy (95 % CI: 11.7, 19.2) bilan solishtirganda (HR 0.68; 95 % CI: 0.53) , 0.87, p = 0.0022). Cemiplimab-rwlc bilagida o'rtacha PFS 6.2 oy (4.5, 8.3) va kimyoterapiya qo'lida o'rtacha PFS 5.6 oy (4.5, 6.1) bo'lgan (HR 0.59; 95 foiz CI: 0.49, 0.72, p0.0001). Cemiplimab-rwlc va kemoterapi guruhlarida BICR bo'yicha tasdiqlangan umumiy javob darajasi (ORR) mos ravishda 37 foiz (95 foiz CI: 32, 42) va 21 foiz (95 foiz CI: 17, 25) edi.
Muskul-skelet sistemasidagi noqulaylik, toshma, anemiya, charchash, ishtahaning pasayishi, pnevmoniya va yo'tal 10-tadqiqotda bitta dori sifatida cemiplimab-rlwc bilan eng ko'p uchraydigan nojo'ya hodisalar (> 1624%) bo'lgan.
NSCLC davolash uchun cemiplimab-rwlcning tavsiya etilgan dozasi har uch haftada 350 mg ni tashkil qiladi, tomir ichiga 30 daqiqa davomida yuboriladi.
Malumot: https://www.fda.gov/
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