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

Background The median overall survival (OS) for patients (pts) with platinum- refractory 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)therapyinCheckMate141 (ptswithplatinum-refractoryR/MSCCHN). Here we present a subgroup analysis of CheckMate 141 in Asian countries. 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.Tabled 1Table: 360O_PR Overall survival and progression-free survival in CheckMate 141:GloballyandinAsiancountriesNivolumabInvestigator's ChoiceHazard Ratio (95% CI)Overall Survival, median (95% CI), monthsGlobal7.5 (5.5-9.1)5.1 (4.0-6.1)0.70 (0.51-0.96)aAsian countries9.5 (9.1-NR)6.2 (2.6-NR)P = 0.01010.50 (0.17-1.48)Progression-Free Survival, median (95% CI), monthsGlobal2.0 (1.9-2.1)2.3 (1.9-3.1)0.89 (0.70-1.1)P = 0.3236Asian countries1.9 (1.6-7.5)1.8 (0.4-6.1)0.57 (0.25-1.33) Open table in a new tab Clinical trial indentification NCT02105636;Study start date, May 2014 Legal entity responsible for the study Ono Pharmaceutical Funding Funded by BMS and Ono Pharmaceutical Disclosure N. Kiyota: Personal fees from ONO (honorarium and research funding) during the conduct of the study payment for seminar presentation from Bristol-Meyers Squibb, Merck Serono and Bayer. Y. Namba, S. Hagihara: Employee of Ono Pharmaceutical. R.L. Ferris: Grants and other from AstraZeneca, grants and other from Merck, other from Pfizer, grants and other from BMS, outside the submitted work. M. Monga: Employee of BMS. M. Tahara: Personal fees from Bristol-Myers Squibb, Merck Sharp & Dohme, Bayer, Otsuka, grants from, Boehringer Ingelheim, Novartis, NanoCarrier, grants and personal fees from Ono Pharmaceutical, Astra Zeneca, Pfizer, Eisai. All other authors have declared no conflicts of interest.