361O Patient-reported Outcomes (pros) in Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treated with Nivolumab (nivo) or Investigator’s Choice (IC): CheckMate 141

Background Patients (pts) with platinum-refractory R/M SCCHN have median survival :::6 mo and suffer from their disease and its treatment. Accordingly, maintaining quality of life (QoL) is a key treatment goal. PRO data were collected as exploratory endpoints in CheckMate 141 (NCT02105636), a randomized, open-label, phase 3 trial comparing nivo to IC (methotrexate, docetaxel, or cetuximab) in 361 pts with platinum-refractory R/M SCCHN. We report the first comparative results for PRO for nivo and IC in R/M SCCHN. Methods The European Organisation for Research and Treatment of Cancer QoL Questionnaire (EORTC QLQ-C30), EORTC Head and Neck Cancer module (QLQ- H&N35), and EQ-5D were administered at baseline (BL), wk 9, and then at 6-wk intervals during treatment. A clinically relevant score change or difference was regarded as 10 points for the EORTC subscales. Analysis of covariance (ANCOVA) was applied to compare mean score changes between arms. Proportional hazards regression was used to evaluate time to clinically relevant score deterioration (TTD). Results BL questionnaire completion rates for nivo and IC were rv80% and rv75%, respectively. Low IC completion rates precluded analysis of mean differences after wk 15. Overall, 129 pts completed a PRO measure at BL and during follow up. Nivo significantly delayed TTD (P < 0.05, 2-tailed) vs IC for global health; physical, role, cognitive, and social functioning; fatigue; dyspnea; and insomnia (EORTC QLQ-C30) as well as pain; sensory problems; and mouth opening problems (QLQ-H&N35). ANCOVA revealed statistically significant, clinically relevant differences favoring nivo at wks 9 and 15 for role and social functioning, fatigue, dyspnea, and appetite loss (EORTC QLQ-C30) as well as pain and sensory problems (QLQ-H&N35). Differences in mean values were observed for other PROs at wk 15 only. Conclusions Pts treated with nivo had delayed worsening of functioning and symptoms with PRO differences between arms favoring nivo up to rv4 mo of follow up. These results, as assessed through wk 15, suggest that pts receiving nivo maintained functioning for longer and had less pain, fatigue, and dyspnea on treatment as compared with IC. Clinical trial indentification NCT02105636; Study start date, May 2014 Legal entity responsible for the study Bristol-Myers Squibb Funding Bristol-Myers Squibb Disclosure N. Kiyota: Grants from research funding, Ono Pharmaceutical Co. Ltd, Eisai Co. Ltd, and Nippon Boehringer Ingelheim Co. Ltd; personal fees (honorarium and research funding), Ono Pharmaceutical Co. Ltd; payment for seminar presentation, BMS, Merck Serono, and Bayer. K. Harrington: Fees paid to research institution by BMS; personal fees from and fees paid to research institution by Merck and Amgen; personal fees from AstraZeneca and Pfizer. R.L. Ferris: Personal fees and advisory board member, Merck and Celgene; grants, personal fees and advisory board member, AZ/Medimmune and BMS; and grants, VentiRx. J.W. Shaw: Employee and shareholder, Bristol-Myers Squibb. F. Taylor: Employee of Adelphi Values, a consulting company that is being paid by BMS to analyze clinical trial PRO data. D. Turner- Bowker: Employee of Adelphi Values, which received funding to conduct this research. L. Morrissey: Employee of Adelphi Values, which was paid for the statistical analyses. K. Cocks: Employee of Adelphi Values, which consults with BMS. M. Gillison: Consulting for BMS, Lilly and Merck Inc. J. Guigay: Grants and advisory board member, Merck; grants, GlaxoSmithKline; advisory board member, Bristol-Myers Squibb and Innate Pharma. All other authors have declared no conflicts of interest.