479OPatient-focused outcomes in RELAY, a phase III trial of ramucirumab plus erlotinib (RamErl) versus placebo plus ERL (PboErl) in untreated EGFR-mutated metastatic NSCLC (EGFR+ mNSCLC)

Abstract Background RELAY showed significantly improved progression free survival (PFS) for RamErl over PboErl in patients with EGFR+ mNSCLC, (mPFS 19.4 vs 12.4 mo; HR 0.59, 95%CI 0.46-0.76; p  Methods Eligible patients were randomized (1:1) to receive 150 mg daily oral Erl plus 10 mg/kg intravenous Ram or Pbo Q2W until progressive disease or unacceptable toxicity. Patients completed the Lung Cancer Symptom Scale (LCSS) and the EQ-5D at baseline, every other cycle, and the 30-day follow-up visit. Two pre-specified analyses, time to deterioration (TtD) for LCSS (secondary endpoint) and TtD in Eastern Cooperative Oncology Group performance status (ECOG PS) (exploratory endpoint) were analyzed using the Kaplan Meier method and Cox models. Changes from baseline were analyzed using a mixed-model repeated measures regression analysis. Results Patients (93.7%) maintained ECOG PS 0/1 in both arms until progression; thus, a TtD analysis was not feasible. Overall patient compliance for LCSS and EQ-5D was high (>95%). TtD for LCSS total score (HR = 0.96 [95% CI: 0.69-1.34] and average symptom burden index TtD (HR = 1.01 [95% CI: 0.73-1.40]) did not differ between treatment arms. TtD of individual LCSS items (appetite loss, fatigue, cough, shortness of breath, blood in sputum [hemoptysis], and pain; symptom distress, difficulties with daily activities, and quality of life) indicated no difference between arms, except in patient-reported hemoptysis (HR = 1.99 [95% CI: 1.21, 3.28]), which favored the PboErl arm. LCSS mean changes from baseline were consistent with TtD. Mean changes from baseline in EQ-5D index score (p = 0.94) and VAS (p = 0.95) revealed no overall differences in health status between treatment arms. Conclusions The addition of Ram to Erl does not impair patient-focused outcomes in RELAY. These quality of life data support the clinical benefit of RamErl in untreated EGFR+ mNSCLC. Clinical trial identification NCT02411448. Editorial acknowledgement Susan P. Whitman, a full-time employee of Eli Lilly and Company, provided medical writing and editing support. Legal entity responsible for the study Eli Lilly and Company. Funding Eli Lilly and Company. Disclosure K. Yoh: Honoraria (self), Research grant / Funding (institution): Eli Lilly and Company, Taiho, Novartis, Ono, AstraZeneca, Chugai; Research grant / Funding (institution): Bayer, Pfizer; Honoraria (self): BMS. S. Atagi: Honoraria (self), Honoraria (institution), financial interests euro500-20000p.a.: AZ, Chugai, MSD, Ono, Taiho, BI, Pfizer, BMS, Eli Lilly; Honoraria (institution), interests euro >250000p.a.: Hoffmann-LaRoche. M. Reck: Honoraria (self), Advisory / Consultancy: AbbVie, Amgen, AZ, BMS, BI, Celgene, Lilly, Merck, MSD, Novartis, Pfizer, Roche. E.B. Garon: Research grant / Funding (institution): AZ, BMS, Lilly, Genentech, Merck, Novartis, Iovance, Neon, Dynavax, Mirati; Advisory / Consultancy, advisory board and steering committee : Dracen, EMD Serono. S. Ponce Aix: Speaker Bureau / Expert testimony: Lilly. D. Moro-Sibilot: Advisory / Consultancy: Roche, BMS, MSD, Takeda, Pfizer, Novartis, AZ, Lilly, BI. K.B. Winfree: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. B. Frimodt-Moller: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. A.H. Zimmermann: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. C.M. Visseren-Grul: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. K. Nakagawa: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSDKK, Eli Lilly Japan KK, BMS, Taiho, Ono, Chugai, AZ KK, Astellas Pharma, Novartis Pharma KK, Nippon BI, Pfizer Japan; Travel / Accommodation / Expenses: Eli Lilly and Company.