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

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

Affiliations

Zoran Andric, MD: Department of Medical Oncology, Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia
Gabriella Gálffy, MD: Pulmonology Hospital Törökbálint, Törökbálint, Hungary
Manuel Cobo Dols, MD: Department of Medical Oncology, Hospital Regional Universitario de Málaga, Institute of Biomedical Research of Málaga (IBIMA), Málaga, Spain
Barna Szima, MD: Department of Pulmonology, Markusovszky Hospital, Szombathely, Hungary
Goran Stojanovic, MD: Institute of Pulmonary Diseases of Vojvodina, Sremska Kamenica, Serbia
Marina Petrovic, MD: Clinic for Pulmonology, Clinical Center Kragujevac, Kragujevac, Serbia
Enriqueta Felip, MD: Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain
David Vicente Baz, MD: Department of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain
Santiago Ponce Aix, MD: Medical Oncology Department, H120-CNIO Lung Cancer Unit, Hospital Universitario 12 de Octubre, Madrid, Spain
Oscar Juan-Vidal, MD: Department of Medical Oncology, Hospital Universitari I Politècnic La Fe, Valencia, Spain
Zsuzsanna Szalai, MD: Department of Pulmonology, Aladar Petz University Teaching Hospital, Győr, Hungary
Gyorgy Losonczy, MD: Faculty of Medicine, Semmelweis University, Budapest, Hungary
Antonio Calles Blanco, MD: Medical Oncology Department, Hospital General Universitario Gregorio Marañon, Madrid, Spain
Reyes Bernabe, MD: Department of Medical Oncology, Hospital Universitario Virgen del Rocio, Seville, Spain
Gema García Ledo, MD: Centro Integral Oncológico Clara Campal HM CIOCC, Hospital Universitario HM Sanchinarro, Madrid, Spain
Andrés Aguilar Hernández, MD: Instituto Oncológico Dr Rosell, Hospital Universitari Quiron Dexeus, Barcelona, Spain
Klaus Duecker, PhD: The Healthcare Business of Merck KGaA, Darmstadt, Germany
Dongli Zhou, PhD: Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., Beijing, China, an affiliate of Merck KGaA, Darmstadt, Germany
Andreas Schroeder, MD: The Healthcare Business of Merck KGaA, Darmstadt, Germany
Guelseren Guezel, MD: The Healthcare Business of Merck KGaA, Darmstadt, Germany
Fortunato Ciardiello, MD, PhD: Division of Medical Oncology, Department of Precision Medicine, The University of Campania Luigi Vanvitelli, Naples, Italy; Corresponding author. Address for correspondence: Fortunato Ciardiello, MD, PhD, Division of Medical Oncology, Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.

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).

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

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