JTO Clinical and Research Reports (Feb 2023)

Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC

  • Zoran Andric, MD,
  • Gabriella Gálffy, MD,
  • Manuel Cobo Dols, MD,
  • Barna Szima, MD,
  • Goran Stojanovic, MD,
  • Marina Petrovic, MD,
  • Enriqueta Felip, MD,
  • David Vicente Baz, MD,
  • Santiago Ponce Aix, MD,
  • Oscar Juan-Vidal, MD,
  • Zsuzsanna Szalai, MD,
  • Gyorgy Losonczy, MD,
  • Antonio Calles Blanco, MD,
  • Reyes Bernabe, MD,
  • Gema García Ledo, MD,
  • Andrés Aguilar Hernández, MD,
  • Klaus Duecker, PhD,
  • Dongli Zhou, PhD,
  • Andreas Schroeder, MD,
  • Guelseren Guezel, MD,
  • Fortunato Ciardiello, MD, PhD

Journal volume & issue
Vol. 4, no. 2
p. 100461

Abstract

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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).

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