2021 kolovoz: 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).
Pacijenti koji su primali cemiplimab-rwlc imali su statistički značajno povećanje OS i PFS u usporedbi s onima koji su primali kemoterapiju na bazi platine. Pacijenti u skupini koja je primala cemiplimab-rwlc imali su medijan OS 22.1 mjesec (95 posto CI: 17.7, NE), u usporedbi sa 14.3 mjeseca (95 posto CI: 11.7, 19.2) u ruci kemoterapije (HR 0.68; 95 posto CI: 0.53 , 0.87, p = 0.0022). Ruka cemiplimab-rwlc imala je medijan PFS-a 6.2 mjeseca (4.5, 8.3), a ruka kemoterapije imala je medijan PFS-a 5.6 mjeseci (4.5, 6.1) (HR 0.59; 95 posto CI: 0.49, 0.72, p0.0001). U skupinama cemiplimab-rwlc i kemoterapije potvrđena ukupna stopa odgovora (ORR) po BICR bila je 37 posto (95 posto CI: 32, 42), odnosno 21 posto (95 posto CI: 17, 25).
Mišićno-koštana nelagoda, osip, anemija, iscrpljenost, smanjeni apetit, upala pluća i kašalj bili su najčešći nuspojave (> 10%) s cemiplimabom-rlwc kao jedinstvenim lijekom u Studiji 1624.
Predložena doza cemiplimaba-rwlc za liječenje NSCLC-om je 350 mg svaka tri tjedna, primijenjena intravenozno tijekom 30 minuta.
Referenca: https://www.fda.gov/
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