501O - Phase 3 efficacy results of a single dose of NEPA, a fixed combination of netupitant and palonosetron, versus a 3-day regimen of aprepitant/granise...

Date 19 November 2017
Event ESMO Asia 2017 Congress
Session Supportive and palliative care
Topics Supportive Care
Palliative and Supportive Care
Presenter Yunpeng Yang
Citation Annals of Oncology (2017) 28 (suppl_10): x155-x165. 10.1093/annonc/mdx676
Authors J. Vanden Burgt1, L. Zhang2, S. Lu3, A. Dechaphunkul4, S. Chessari5, C. Lanzarotti6, K. Jordan7, M. Aapro8
  • 1Medical Affairs, Helsinn Healthcare, Edina/US
  • 2State Key Laboratory Of Oncology In South China, Collaborative Innovation Center For Cancer Medicine, Cancer Centre Sun Yat-Sen University, 510060 - Guangzhou/CN
  • 3Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai/CN
  • 4Division Of Medical Oncology, Prince of Songkla University, Songkhla/TH
  • 5Corporate Clinical Development, Helsinn Healthcare, Lugano/CH
  • 6Statistics & Data Management, Helsinn Healthcare, Lugano/CH
  • 7Department Of Medicine V, University of Heidelberg, Heidelberg/DE
  • 8Multidisciplinary Oncology Institute, Cancer Center, Clinique de Genolier, Genolier/CH

Abstract

Background

Antiemetic guidelines universally recommend the combination of an NK1 receptor antagonist (NK1RA), a 5-HT3RA, and dexamethasone (DEX) for patients receiving highly emetogenic chemotherapy (HEC). NEPA is the first oral fixed combination of an NK1RA (netupitant) and a 5-HT3RA (palonosetron, PALO). The approval of oral NEPA in the United States/Europe was based on studies demonstrating superiority of NEPA compared to oral PALO. In a recent head-to-head trial in Asia NEPA showed comparable efficacy/safety to a 3-day regimen of APR/GRAN. This is a pre-specified analysis of the efficacy of NEPA vs APR/GRAN in the Chinese patients in that study.

Methods

Chemotherapy-naïve solid tumor cancer patients in this randomized double-blind, parallel group study received either a single oral dose of NEPA prior to cisplatin-based HEC or a 3-day regimen of APR/GRAN, both with oral DEX on days 1-4. The efficacy endpoint evaluated was complete response (no emesis/no rescue medication) during the acute (0-24h), delayed (25-120h) and overall (0-120h) phases post-chemotherapy for the full analysis set (FAS). The risk difference for NEPA – APR/GRAN and associated 95% confidence intervals (CI) were analyzed using the Cochran-Mantel-Haenszel test.

Results

667 (81%) of the total FAS population (n = 828) were Chinese. Groups were comparable in this subset (NEPA/APR): most were male (69.0/69.5%), mean age 54.4/54.9 years, ECOG 0-1 (98.2/97.6%), lung cancer (70.9/67.4%). Response rates were similar for the treatment groups.Table: 501O

% PatientsNEPA (N = 339)APR/GRAN (N = 328)Risk Difference % 95% CI
Complete Response
Acute (0-24 h)84.4%87.8%-3.4% (-8.6%, 1.8%)
Delayed (25-120 h)78.8%75.3%3.5% (-2.8%, 9.9%)
Overall (0-120 h)74.0%73.8%0.3% (-6.3%, 7.0%)

Conclusions

Oral NEPA administered only on day 1 showed comparable efficacy to a 3-day APR/GRAN regimen in Chinese patients receiving HEC. As a fixed oral combination of an NK1RA and 5HT3RA in a single capsule given once/cycle, NEPA offers patients a convenient effective prophylactic antiemetic.

Clinical trial identification

Legal entity responsible for the study

Helsinn Healthcare, SA, Lugano, Switzerland

Funding

Helsinn Healthcare, SA

Disclosure

L. Zhang: Consultant for MSD; research funding from Helsinn, Lilly, and MSD, S. Lu: Consultant for Boehringer and Roche; speaker’s bureau for Lilly; travel reimbursed by Hutchison and Medipharm Limited, S. Chessari, C. Lanzarotti: Employee of Helsinn Healthcare, K. Jordan: Consultant for Helsinn Healthcare, Merck, MSD and Tesaro; travel reimbursed by MSD, M. Aapro: Consultant/investigator for Helsinn Healthcare, Merck and Tesaro

All other authors have declared no conflicts of interest.