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Annals of Oncology 29: 452–458, 2018
doi:10.1093/annonc/mdx698
Published online 28 October 2017

ORIGINAL ARTICLE

A randomized phase III study evaluating the efficacy

of single-dose NEPA, a fixed antiemetic combination

of netupitant and palonosetron, versus an aprepitant

regimen for prevention of chemotherapy-induced

nausea and vomiting (CINV) in patients receiving

highly emetogenic chemotherapy (HEC)

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L. Zhang 1,2,3 * , S. Lu , J. Feng , A. Dechaphunkul , J. Chang , D. Wang , S. Chessari , C. Lanzarotti ,
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K. Jordan & M. Aapro 12
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1 State Key Laboratory of Oncology in South China, Guangzhou; Collaborative Innovation Center for Cancer Medicine, Guangzhou; Medical Oncology
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Department, Sun Yat-Sen University Cancer Center, Guangzhou; Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University,
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Shanghai; Medical Oncology, Jiangsu Cancer Hospital, Nanjing, China; Division of Medical Oncology, Internal Medicine, Prince of Songkla University, Songkhla,
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Thailand; Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai; Cancer Center, Daping Hospital, Third Military Medical
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University, Chongqing, China; Corporate Clinical Development, Helsinn Healthcare, Lugano; Statistics and Data Management, Helsinn Healthcare, Lugano,
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Switzerland; Department of Medicine V, University of Heidelberg, Heidelberg, Germany; Cancer Center, Clinique de Genolier, Genolier, Switzerland
*Correspondence to: Prof. Li Zhang, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine; Medical Oncology Department,
Sun Yat-Sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, China. Tel: þ86-20-87-34-22-88; E-mail: zhangli@sysucc.org.cn
Background: Co-administration of multiple antiemetics that inhibit several molecular pathways involved in emesis is required
to optimize chemotherapy-induced nausea and vomiting (CINV) control in patients receiving highly emetogenic chemotherapy
(HEC). NEPA, a fixed combination of a highly selective NK 1 receptor antagonist, netupitant (300 mg), and the pharmacologically
distinct 5-HT 3 RA, palonosetron (PALO 0.50 mg), has shown superior CINV prevention compared with PALO in cisplatin and
anthracycline/cyclophosphamide-based settings. This study is the first head-to-head comparison of NEPA versus an aprepitant
(APR)/granisetron (GRAN) regimen.
Patients and methods: This randomized, double-blind phase III study conducted in Asia was designed with the primary
objective to demonstrate non-inferiority of a single oral dose of NEPA compared with a 3-day oral APR/GRAN regimen in
chemotherapy-naı¨ve patients receiving cisplatin-based HEC. All patients also received oral dexamethasone (DEX) on days 1–4.
The primary efficacy endpoint was complete response (CR: no emesis/no rescue medication) during the overall (0–120 h) phase.
Non-inferiority was defined as a lower 95% CI greater than the non-inferiority margin set at � 10%. Secondary efficacy
endpoints included no emesis, no rescue medication, and no significant nausea (NSN).
Results: Treatment groups were comparable for the 828 patients analyzed: predominantly male (71%); mean age 54.5 years;
ECOG 0–1 (98%); lung cancer (58%). NEPA demonstrated non-inferiority to APR/GRAN for overall CR [NEPA 73.8% versus APR/
GRAN 72.4%, 95% CI (�4.5%, 7.5%)]. No emesis [NEPA 75.0% versus APR/GRAN 74.0%, 95% CI (�4.8%, 6.9%)] and NSN rates
[NEPA 75.7% versus APR/GRAN 70.4%, 95% CI (�0.6%, 11.4%)] were similar between groups, but significantly more NEPA
patients did not take rescue medication [NEPA 96.6% versus APR/GRAN 93.5%, 95% CI (0.2%, 6.1%)]. NEPA was well tolerated
with a similar safety profile to APR/GRAN.

V The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
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This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use,
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