LBA47_PRPHASE 3 (P04832) TRIAL RESULTS FOR ROLAPITANT, A NOVEL NK-1 RECEPTOR ANTAGONIST, IN THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) IN PATIENTS RECEIVING CISPLATIN-BASED CHEMOTHERAPY

ABSTRACT Aim: Rolapitant is a highly selective competitive long acting NK-1 receptor antagonist that demonstrated safety and prevention of CINV in both phase 2 and 3 trials. Methods: A multi-center, randomized double-blind phase 3 trial was conducted in patients (pts) receiving cisplatin-based chemotherapy. 532 pts were randomized 1:1 to receive oral rolapitant + granisetron/dexamethasone (G/D) or placebo + G/D prior to chemotherapy. The primary endpoint was complete response (CR; no emesis/no rescue meds) in the delayed phase (>24-120 hrs) post-chemotherapy. Key secondary endpoints included CR during acute (0-24 hrs) and overall (0-120 hrs) phases. Treatment comparisons were performed using a Mantel-Haenszel chi-square test; to control for type 1 error, testing was conducted in a stepwise fashion for key secondary endpoints. A regional CR analysis was prospectively conducted on North America (NA), Asia/South Africa (ASA), Europe (E), and Central/South America (CSA). Daily quality of life (QoL) was assessed via Functional Living Index-Emesis Questionnaire. Results: Demographics were well balanced with a mdn age of 57.3y (range 20-90). The primary objective of this study was achieved with a higher CR rate in the delayed phase compared to placebo (72.7% vs 58.4%, p Delayed Phase Acute Phase Region Rolapitant CR% Placebo CR% Rolapitant CR% Placebo CR% NA 59.5 46.7 78.6 71.1 ASA 62.3 45.5 73.8 70.9 E 83.5 72.4 93.2 83.6 CSA 64.3 35.7 67.9 35.7 Conclusions: Rolapitant + G/D was well tolerated and superior to G/D alone in preventing CINV in pts receiving cisplatin-based therapies, and this effect was observed across geographic regions. Disclosure: A. Poma, M.L. Hedley and R. Martell: is an employee of TESARO, the sponsor of this abstract. All other authors have declared no conflicts of interest.