LBA47_PR Phase 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

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 < 0.001). Statically significant results were also observed in key secondary endpoints of acute phase CR rate (83.7% vs 73.7%, p = 0.005), and overall CR rate (70.1% vs 56.5%, p =0.001). Slightly more pts reported no impact on daily QoL with rolapitant (72.8% vs 67.8%, p = 0.231). Addition of rolapitant conferred a CR improvement across geographic regions in both the delayed and acute phases (table). Treatment emergent AEs were consistent across both arms, and generally related to underlying medical condition or chemotherapy. Unlabelled Table 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.