LBA47_PR - Phase 3 (P04832) trial results for rolapitant, a novel NK-1 receptor antagonist, in the prevention of chemotherapy-induced nausea and vomiting (CIN...
| Date | 27 September 2014 |
| Event | ESMO 2014 |
| Session | Supportive and palliative care |
| Topics | Supportive Care |
| Presenter | Bernardo Rapoport |
| Citation | Annals of Oncology (2014) 25 (5): 1-41. 10.1093/annonc/mdu438 |
| Authors |
M.R. Chasen1, A. Poma2, M.L. Hedley3, R.E. Martell2, C. Gridelli4
|
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 < 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.
| 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.