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).
Pasienter som fikk cemiplimab-rwlc hadde statistisk signifikante økninger i OS og PFS sammenlignet med de som fikk platinabasert cellegift. Pasienter i cemiplimab-rwlc-gruppen hadde en median OS på 22.1 måneder (95 prosent KI: 17.7, NE), sammenlignet med 14.3 måneder (95 prosent KI: 11.7, 19.2) i cellegiftarmen (HR 0.68; 95 prosent KI: 0.53 0.87, p = 0.0022). Cemiplimab-rwlc-armen hadde en median PFS på 6.2 måneder (4.5, 8.3) og cellegiftarmen hadde en median PFS på 5.6 måneder (4.5, 6.1) (HR 0.59; 95 prosent KI: 0.49, 0.72, p0.0001). I gruppene cemiplimab-rwlc og kjemoterapi var henholdsvis den bekreftede generelle responsraten (ORR) per BICR 37 prosent (95 prosent KI: 32, 42) og 21 prosent (95 prosent KI: 17, 25).
Muskel- og skjelettplager, utslett, anemi, utmattelse, nedsatt appetitt, lungebetennelse og hoste var de vanligste bivirkningene (> 10%) med cemiplimab-rlwc som et enkelt legemiddel i studie 1624.
Den foreslåtte dosen cemiplimab-rwlc for NSCLC-behandling er 350 mg hver tredje uke, administrert intravenøst over 30 minutter.
Henvisning : https://www.fda.gov/
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