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. (September 2019)

• Record Type: Journal Article
• Authors: Saba, Nabil F.; Blumenschein, George; Guigay, Joel; Licitra, Lisa; Fayette, Jerome; Harrington, Kevin J.; Kiyota, Naomi; Gillison, Maura L.; Ferris, Robert L.; Jayaprakash, Vijayvel; Li, Li; Brossart, Peter
• Is Part Of: Oral oncology. Volume 96(2019)
• Page Start: 7
• Page End: 14
• Publication Date: 2019-09
• Subjects: Biomarkers -- Nivolumab -- Squamous cell carcinoma of the head and neck -- Age -- Phase 3 clinical trial; CI confidence interval -- ECOG Eastern Cooperative Oncology Group -- HPV human papillomavirus -- HR hazard ratio -- IC investigator's choice -- NR not reached -- ORR objective response rate -- OS overall survival -- PD-1 programmed death-1 -- PD-L1 programmed death ligand 1 -- PFS progression-free survival -- SCCHN squamous cell carcinoma of the head and neck -- TRAE treatment-related adverse event; Mouth -- Cancer -- Periodicals; Mouth -- Tumors -- Periodicals; Mouth Diseases -- Periodicals; Mouth Neoplasms -- Periodicals; Bouche -- Cancer -- Périodiques; Bouche -- Tumeurs -- Périodiques; Tumeurs -- Périodiques; Electronic journals; 616.9943105
• DOI: 10.1016/j.oraloncology.2019.06.017
• Languages: English
• ISSNs: 1368-8375

Abstract

Highlights: CheckMate 141 evaluated nivolumab in patients with R/M SCCHN post-platinum therapy. We present a post hoc analysis of CheckMate 141 evaluating patient subgroups by age. OS was higher with nivolumab vs chemotherapy irrespective of age (<65 and ≥65 years) Nivolumab had a consistent safety profile across age groups. These data are consistent with results seen in the overall patient population. 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 .