Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression.

Abstract

OBJECTIVES:

We report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M),platinum-refractory squamous cell carcinoma of the head and neck (SCCHN).

METHODS:

Patients with R/M SCCHN with tumor progression/recurrence within 6 months of platinum therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017.

RESULTS:

With 24.2 months' minimum follow-up, nivolumab (n = 240) continued to improve OS vs IC (n = 121), hazard ratio (HR) = 0.68 (95% CI 0.54-0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression ≥1% (HR [95% CI] = 0.55 [0.39-0.78]) and  < 1% (HR [95% CI] = 0.73 [0.49-1.09]), and regardless of tumor HPV status. Estimated OS rates at 18, 24, and 30 months with nivolumab were consistent irrespective of PD-L1 expression (<1%/≥1%). In the nivolumab arm, there were no observed differences in baseline characteristics or safety profile between long-term survivors and the overall population. Grade 3-4 treatment-related adverse event rates were 15.3% and 36.9% for nivolumab and IC, respectively.

CONCLUSION:

Nivolumab significantly improved OS at the primary analysis and demonstrated prolonged OS benefit vs IC and maintenance of a manageable and consistent safety profile with 2-year follow-up. OS benefit was observed with nivolumab irrespective of PD-L1 expression and HPV status. (Clinicaltrials.gov: NCT02105636).

• Authors: Robert L Ferris, George Blumenschein Jr, Jerome Fayette, Joel Guigay, A Dimitrios Colevas, Lisa Licitra, Kevin J Harrington, Stefan Kasper, Everett E Vokes, Caroline Even, Francis Worden, Nabil F Saba, Lara Carmen Iglesias Docampo, Robert Haddad, Tamara Rordorf, Naomi Kiyota, Makoto Tahara, Mark Lynch, Vijayvel Jayaprakash, Li Li, Maura L Gillison
• Journal: Oral oncology (Oral Oncol) Vol. 81 Pg. 45-51 (06 2018) ISSN: 1879-0593 [Electronic] England
• PMID: 29884413 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018. Published by Elsevier Ltd.

Chemical References

• Antineoplastic Agents, Immunological
• B7-H1 Antigen
• CD274 protein, human
• Nivolumab

Topics

• Antineoplastic Agents, Immunological (adverse effects, therapeutic use)
• B7-H1 Antigen (metabolism)
• Humans
• Neoplasm Metastasis
• Neoplasm Recurrence, Local
• Nivolumab (adverse effects, therapeutic use)
• Squamous Cell Carcinoma of Head and Neck (drug therapy, pathology)
• Survival Analysis