Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age

• Type of Material: Article
• Authors: Nabil Saba, Emory University; George Blumenschein, MD Anderson Cancer Center; Joel Guigay, Université Côte d’Azur; Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori; Jerome Fayette, Centre Leon Berard; Kevin J. Harrington, Royal Marsden NHS Foundation Trust; Naomi Kiyota, Kobe University Hospital Cancer Center; Maura L. Gillison, MD Anderson Cancer Center; Robert L. Ferris, University of Pittsburgh; Vijayvel Jayaprakash, Bristol-Myers Squibb; Li Li, Bristol-Myers Squibb; Peter Brossart, University Hospital of Bonn
• Language: English
• Date: 2019-09-01
• Publisher: ELSEVIER
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: 2019
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.oraloncology.2019.06.017
• Title of Journal or Parent Work: ORAL ONCOLOGY
• Volume: 96
• Start Page: 7
• End Page: 14
• Grant/Funding Information: Writing and editorial assistance was provided by Brooke Middlebrook, BS, of Evidence Scientific Solutions, funded by Bristol-Myers Squibb. K. J. Harrington acknowledges support from the Royal Marsden/the Institute of Cancer Research, National Institute of Health Research Biomedical Research Centre, and Oracle Cancer Trust. R. L. Ferris is supported by the P50 CA097190-14, P30 CA047904-28, and R01 CA206517 grants. The University of Texas MD Anderson Cancer Center is supported by the National Institutes of Health (grant P30 CA016672).; This study was sponsored by Bristol-Myers Squibb (Princeton, NJ, USA) and ONO Pharmaceutical Company, Ltd. (Osaka, Japan).
• Keywords: Oncology; Nivolumab; ELDERLY-PATIENTS; Age; Science & Technology; CHEMOTHERAPY; OLDER-ADULTS; IRRADIATION; MANAGEMENT; Phase 3 clinical trial; CANCER; Life Sciences & Biomedicine; Squamous cell carcinoma of the head and neck; Dentistry, Oral Surgery & Medicine; IMMUNOTHERAPY; GERIATRIC ONCOLOGY; INHIBITORS; Biomarkers
• Research Categories: Health Sciences, Immunology; Health Sciences, Oncology; Health Sciences, Medicine and Surgery

Abstract

Objectives: Many patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator's choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age. Patients and methods: Eligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and ≥65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months). Results: At baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were ≥65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (<65 years) and 13.0% (≥65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population. Conclusion: In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups. ClinicalTrials.gov: NCT02105636.