2026-08-12T20:34:02Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/231052024-11-29T21:56:27Zcom_20.500.12105_2173com_20.500.12105_2051col_20.500.12105_19597

00925njm 22002777a 4500 dc Andric, Zoran author Gálffy, Gabriella author Cobo Dols, Manuel author Szima, Barna author Stojanovic, Goran author Petrovic, Marina author Felip, Enriqueta author Vicente Baz, David author Ponce Aix, Santiago author Juan-Vidal, Oscar author Szalai, Zsuzsanna author Losonczy, Gyorgy author Calles Blanco, Antonio author Bernabe, Reyes author García Ledo, Gema author Aguilar Hernández, Andrés author Duecker, Klaus author Zhou, Dongli author Schroeder, Andreas author Guezel, Guelseren author Ciardiello, Fortunato author 2023-02 INTRODUCTION: We present the results of a phase 2a trial of first-line avelumab (anti-programmed death-ligand 1 antibody) plus cetuximab (anti-EGFR antibody) in patients with advanced squamous NSCLC. METHODS: Patients with recurrent or metastatic squamous NSCLC received avelumab 800 mg (d 1 and 8), cetuximab 250 mg/m2 (d 1) and 500 mg/m2 (d 8), cisplatin 75 mg/m2 (d 1), and gemcitabine 1250 mg/m2 (d 1 and 8) for four 3-week cycles, followed by avelumab 800 mg and cetuximab 500 mg/m2 every 2 weeks. The primary end point was the best overall response; the secondary end points were progression-free survival, duration of response, overall survival, and safety. Efficacy analyses were reported from an updated data cutoff. RESULTS: A total of 43 patients were enrolled. The median follow-up was 6.6 months for the primary analyses and 9.2 months for the efficacy analyses. In the efficacy analyses, 15 patients had a confirmed partial response (objective response rate, 34.9% [95% confidence interval: 21.0%-50.9%]), and the median duration of response was 7.1 months (95% confidence interval: 4.2-12.5 mo). The median progression-free survival and overall survival were 6.1 months and 10.0 months, respectively. In the safety analyses (primary analysis), 38 patients (88.4%) had a treatment-related adverse event, of whom 24 (55.8%) had a grade 3 or higher treatment-related adverse event. CONCLUSIONS: The combination of avelumab + cetuximab and chemotherapy showed antitumor activity and tolerable safety; however, the ORR was not improved compared with those reported for current standards of care (NCT03717155). JTO Clin Res Rep . 2023;4(2):100461 10.1016/j.jtocrr.2022.100461 2666-3643 JTO clinical and research reports 36718142 https://hdl.handle.net/20.500.12105/23105 Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC.