360O_PR Efficacy and safety of nivolumab for recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) in Asia: CheckMate 141 subgroup analysis

Abstract

Background: The median overall survival (OS) for patients (pts) with platinumrefractory R/M SCCHN is ≤6 months (mo). Nivolumab (nivo), an anti‐PD‐1, fully human IgG4 monoclonal antibody, demonstrated OS benefit compared to investigator's choice (IC) therapy in CheckMate 141 (pts with platinum‐refractory R/M SCCHN). Here we present a subgroup analysis of CheckMate 141 in Asian countries. Methods: The phase 3, open‐label CheckMate 141 trial enrolled pts aged ≥18 years with R/M SCCHN and ECOG performance status ≤1. Pts were randomized 2:1 to receive nivo or IC (methotrexate, docetaxel, or cetuximab) until disease progression or toxicity. Primary endpoint was OS; secondary endpoints included progression‐free survival (PFS), objective response rate per RECIST 1.1, and quality of life. Results: Globally, 361 pts were randomized, 34 (9.4%) of whom were in Asia (27 in Japan, 5 in Taiwan, 1 in Korea, 1 in Hong Kong). At the time of analysis, globally there were 133 (55.4%) and 85 (70.2%) deaths in the nivo and IC arms, respectively, and in Asia 7 (30.4%) and 6 (54.5%) deaths, respectively. OS and PFS are reported in the table. In the nivo arm, the incidence of treatment‐related adverse events (TRAEs) of any grade was 58.9% globally and 69.6% in Asia; grade 3‐4 TRAEs occurred in 13.1% and 8.7% of pts, respectively. No treatment‐related deaths were reported in Asia. Conclusions: The efficacy and safety profiles of nivo in platinum‐refractory R/M SCCHN in Asian countries were similar to those in the global population. Nivo is the first immunotherapy to demonstrate a significant improvement in survival for pts with R/M SCCHN who progress after platinum‐based therapy and is likely to become a standard of care option for R/M SCCHN in Asia.