LAUSR

POSTER DISCUSSION SESSION 1 AUGUST 18, 2018 — 08:00 e 09:15 PD.1.01 Health-Related Quality of Life with Pembrolizumab or Placebo + Pemetrexed + Platinum in Non-Squamous NSCLC: KEYNOTE-189 M. Garassino, D. Rodríguez-Abreu, S. Gadgeel, E. Esteban, E. Felip, G. Speranza, M. Domine, M. Hochmair, S. Powell, S. Cheng, H. Bischoff, N. Peled, M. Reck, R. Hui, E. Garon, M. Boyer, J. Yang, T. Burke, M.C. Pietanza, L. Gandhi Fondazione IRCCS Istituto Nazionale dei Tumori, Milan/IT, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria/ES, University of Michigan, Ann Arbor/MI/US, Hospital Universitario Central de Asturias, Oviedo/ES, Vall d’Hebron University, Vall d’Hebron Institute of Oncology (VHIO), Barcelona/ES, Centre Integré de Cancérologie de la Montérégie, Hôpital Charles Le Moyne, Greenfield Park, QC/CA, Fundación Jiménez Díaz, Madrid/ES, Otto Wagner Hospital, Vienna/AT, Sanford Health, Sioux Falls, SD/US, Sunnybrook Health Sciences Centre, Toronto, ON/CA, Thoraxklinik, Heidelberg/DE, Clalit Health Services, Soroka Medical Center, Beer-Sheeva/IL, LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf/DE, Westmead Hospital and the University of Sydney, Sydney, NSW/AU, David Geffen School of Medicine at UCLA, Los Angeles, CA/US, Chris O’Brien Lifehouse, Camperdown, NSW/AU, Merck & Co., Inc., Kenilworth, NJ/US, NYU Perlmutter Cancer Center, New York, NY/US Background: In the double-blind, phase 3 KEYNOTE-189 study (NCT02578680), pembrolizumab+pemetrexed/platinum significantly improved OS and PFS over placebo+pemetrexed/platinum as first-line therapy for nonsquamous NSCLC. Overall, the incidence and severity of AEs with pembrolizumab+pemetrexed/platinum was similar to those with placebo+pemetrexed/platinum. We report the prespecified patient-reported outcome (PRO) analyses from KEYNOTE-189.Method: 616 patients were randomized to pembrolizumab 200 mg Q3W or placebo for 2 years; all patients received pemetrexed plus 4 cycles of carboplatin/cisplatin. EORTC QLQ-C30 and QLQ-LC13 were administered at cycles 1-5, then every 3 cycles during year 1, and every 4 cycles during years 2/3. Key PROs were change from baseline to weeks 12 and 21 in the QLQ-C30 global health status (GHS)/quality of life (QoL) score and time to deterioration in composite of cough/chest pain/ dyspnea. PROs were analyzed in all treated patients who completed 1 PRO instrument (n 1⁄4 602). P values are nominal and 2-sided. Results: QLQ-C30 compliance was w90% at baseline and week 12 in both arms and was w76% with pembrolizumab and w64% with placebo at week 21. Mean baseline scores were 61.98 and 60.56 in the pembrolizumab and placebo arms, respectively. At weeks 12 and 21, GHS/QoL scores were stable with pembrolizumab and decreased with placebo, with significantly greater decrement with placebo at week 21 (Table). The proportion of improved GHS/QoL was similar at week 12 (28.9% with pembrolizumab vs 26.5% with placebo) but was greater with pembrolizumab at week 21 (30.1% vs 22.5%). Median time to deterioration in composite of cough/chest pain/dyspnea was not reached (NR) with pembrolizumab (95% CI, 10.2 months-NR) vs 7.0 months (95% CI, 4.8-NR) with placebo (HR, 0.81; 95% CI, 0.60-1.09; P1⁄40.161). Conclusion: In KEYNOTE-189, pembrolizumab+pemetrexed/platinum maintained or improved health-related QoL over placebo+pemetrexed/ platinum. These data support use of pembrolizumab+pemetrexed/ platinum as first-line therapy for metastatic nonsquamous NSCLC.