Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC
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),...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-02-01
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| Series: | JTO Clinical and Research Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666364322001862 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Zoran Andric, MD |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-04-10T07:12:38Z |
| format | Article |
| id | doaj.art-283d0b24db6b460b8d6628f029ba7cc0 |
| institution | Directory Open Access Journal |
| issn | 2666-3643 |
| language | English |
| last_indexed | 2024-04-10T07:12:38Z |
| publishDate | 2023-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JTO Clinical and Research Reports |
| spelling | doaj.art-283d0b24db6b460b8d6628f029ba7cc02023-02-26T04:28:20ZengElsevierJTO Clinical and Research Reports2666-36432023-02-0142100461Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLCZoran Andric, MD0Gabriella Gálffy, MD1Manuel Cobo Dols, MD2Barna Szima, MD3Goran Stojanovic, MD4Marina Petrovic, MD5Enriqueta Felip, MD6David Vicente Baz, MD7Santiago Ponce Aix, MD8Oscar Juan-Vidal, MD9Zsuzsanna Szalai, MD10Gyorgy Losonczy, MD11Antonio Calles Blanco, MD12Reyes Bernabe, MD13Gema García Ledo, MD14Andrés Aguilar Hernández, MD15Klaus Duecker, PhD16Dongli Zhou, PhD17Andreas Schroeder, MD18Guelseren Guezel, MD19Fortunato Ciardiello, MD, PhD20Department of Medical Oncology, Clinical Hospital Center Bezanijska Kosa, Belgrade, SerbiaPulmonology Hospital Törökbálint, Törökbálint, HungaryDepartment of Medical Oncology, Hospital Regional Universitario de Málaga, Institute of Biomedical Research of Málaga (IBIMA), Málaga, SpainDepartment of Pulmonology, Markusovszky Hospital, Szombathely, HungaryInstitute of Pulmonary Diseases of Vojvodina, Sremska Kamenica, SerbiaClinic for Pulmonology, Clinical Center Kragujevac, Kragujevac, SerbiaVall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, SpainDepartment of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, SpainMedical Oncology Department, H120-CNIO Lung Cancer Unit, Hospital Universitario 12 de Octubre, Madrid, SpainDepartment of Medical Oncology, Hospital Universitari I Politècnic La Fe, Valencia, SpainDepartment of Pulmonology, Aladar Petz University Teaching Hospital, Győr, HungaryFaculty of Medicine, Semmelweis University, Budapest, HungaryMedical Oncology Department, Hospital General Universitario Gregorio Marañon, Madrid, SpainDepartment of Medical Oncology, Hospital Universitario Virgen del Rocio, Seville, SpainCentro Integral Oncológico Clara Campal HM CIOCC, Hospital Universitario HM Sanchinarro, Madrid, SpainInstituto Oncológico Dr Rosell, Hospital Universitari Quiron Dexeus, Barcelona, SpainThe Healthcare Business of Merck KGaA, Darmstadt, GermanyMerck Serono (Beijing) Pharmaceutical R&D Co., Ltd., Beijing, China, an affiliate of Merck KGaA, Darmstadt, GermanyThe Healthcare Business of Merck KGaA, Darmstadt, GermanyThe Healthcare Business of Merck KGaA, Darmstadt, GermanyDivision 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.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).http://www.sciencedirect.com/science/article/pii/S2666364322001862AvelumabCetuximabPD-L1EGFRNon–small cell lung cancer |
| spellingShingle | 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 Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC JTO Clinical and Research Reports Avelumab Cetuximab PD-L1 EGFR Non–small cell lung cancer |
| title | Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC |
| title_full | Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC |
| title_fullStr | Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC |
| title_full_unstemmed | Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC |
| title_short | Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC |
| title_sort | avelumab in combination with cetuximab and chemotherapy as first line treatment for patients with advanced squamous nsclc |
| topic | Avelumab Cetuximab PD-L1 EGFR Non–small cell lung cancer |
| url | http://www.sciencedirect.com/science/article/pii/S2666364322001862 |
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