Augusta 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).
Pacienti, ktorí dostávali cemiplimab-rwlc, mali štatisticky významné zvýšenia OS a PFS v porovnaní s tými, ktorí dostávali chemoterapiu na báze platiny. Pacienti v skupine s cemiplimab-rwlc mali medián OS 22.1 mesiaca (95 percent CI: 17.7, NE) v porovnaní so 14.3 mesiacmi (95 percent CI: 11.7, 19.2) v ramene s chemoterapiou (HR 0.68; 95 percent CI: 0.53 0.87, p = 0.0022). Rameno cemiplimab-rwlc malo medián PFS 6.2 mesiaca (4.5, 8.3) a rameno chemoterapie malo medián PFS 5.6 mesiaca (4.5, 6.1) (HR 0.59; 95 percent IS: 0.49, 0.72, p0.0001). V skupinách s cemiplimab-rwlc a chemoterapiou bola potvrdená celková miera odpovede (ORR) na BICR 37 percent (95 percent IS: 32, 42) a 21 percent (95 percent CI: 17, 25).
Muskuloskeletálny diskomfort, vyrážka, anémia, vyčerpanie, znížená chuť do jedla, zápal pľúc a kašeľ boli najčastejšími nežiaducimi účinkami (> 10%) pri cemiplimab-rlwc ako jednom lieku v štúdii 1624.
Odporúčaná dávka cemiplimab-rwlc na liečbu NSCLC je 350 mg každé tri týždne, podávaná intravenózne počas 30 minút.
Referencia: https://www.fda.gov/
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