Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)

Chia Jui Yen, Naomi Kiyota, Nobuhiro Hanai, Shunji Takahashi, Tomoya Yokota, Shigemichi Iwae, Yasushi Shimizu, Ruey Long Hong, Masahiro Goto, Jin Hyoung Kang, Wing Sum Kenneth Li, Robert L. Ferris, Maura Gillison, Toshimitsu Endo, Vijayvel Jayaprakash, Makoto Tahara

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial. Methods: The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed. Results: The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs. Conclusions: Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy. Clinical trial registration: NCT02105636.

Original languageEnglish
Pages (from-to)2852-2862
Number of pages11
JournalHead and Neck
Volume42
Issue number10
DOIs
Publication statusPublished - 2020 Oct 1

All Science Journal Classification (ASJC) codes

  • Otorhinolaryngology

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