Three studies of NEPA for Nausea published in Annals of Oncology-Eisai

The complete results of the three Phase II/III pivotal trials for NEPA (netupitant and palonosetron ) oral fixed-dose combination capsule, from Eisai, for patients with Nausea, have been published, together with an accompanying editorial, in the July issue of Annals of Oncology. Hesketh et al. was a pivotal, Phase II study in 694 patients undergoing cisplatin-based, highly emetogenic chemotherapy. All NEPA doses showed significantly higher overall (0-120 hour) complete response rates (no emesis, no rescue medication), the primary endpoint, compared with oral palonosetron, with the highest NEPA (300 mg) dose studied showing an incremental benefit over lower NEPA doses for all efficacy endpoints.

Aapro et al. was a Phase III study in 1455 chemotherapy-na�ve patients receiving anthracycline-cyclophosphamide moderately emetogenic chemotherapy. The percentage of patients who met the primary endpoint of complete response in the delayed (25-120 hours) phase was significantly higher in the NEPA group compared with the oral palonosetron group, which was also seen in the acute (0-24 hours) and overall (0-120 hours) phases post chemotherapy. The Gralla et al Phase III study in 413 patients was designed primarily to demonstrate the safety of NEPA over multiple cycles of either highly (24% of patients) or moderately emetogenic chemotherapy (76% of patients). Patients completed 1961 total chemotherapy cycles with 75% of patients completing ?4 cycles. The adverse event profile was consistent with that expected for patients undergoing cytotoxic chemotherapy, with the most frequently reported treatment-related events being headache and constipation.

Netupitant and palonosetron (NEPA): a winning team in the race for the optimal treatment of chemotherapy-induced nausea and vomiting?"- P. L. R. Andrews- Ann Oncol (2014) 25 (7): 1258-1259 first published online June 18, 2014.