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Evaluation of nausea control with NEPA, a novel oral combination antiemetic.

169 Background: The introduction of NK1 receptor antagonists (RAs) improved the control of chemotherapy-induced nausea and vomiting. However, prevention of nausea, particularly in the delayed phase remains suboptimal, with no consistent superiority seen with the addition of aprepitant over 5-HT3 RAs + dexamethasone (DEX). NEPA, a fixed-dose oral combination of the new NK1RA, netupitant (NETU 300 mg) plus palonosetron (PALO 0.50 mg) targets two main antiemetic pathways with a convenient single dose. NEPA has shown superior complete response rates (no vomiting and no rescue use) compared with PALO in pivotal trials. This analysis summarizes the nausea control seen with NEPA in all 3 pivotal trials in the clinical development program.


METHODS
Patients in 3 randomized, double-blind trials received a single dose of NEPA + DEX prior to a variety of either highly emetogenic (HEC) (Studies 1 and 3) or moderately emetogenic (MEC) (Studies 2 and 3) chemotherapeutic agents. Patients receiving HEC also received additional DEX on Days 2-4. Nausea was measured daily with a 100 mm visual analog scale (VAS). The proportion of patients with no significant nausea (VAS <25 mm) were summarized (Table).


RESULTS
In Studies 1 and 2, NEPA was significantly more effective in controlling delayed and overall nausea compared with PALO (Table). The greatest nausea control with NEPA was seen in the non-AC MEC and HEC settings.


CONCLUSIONS
This summary suggests that NEPA + DEX improves control of nausea during the delayed and overall periods following chemotherapy. High levels of nausea control were seen and were most noteworthy in patients receiving HEC or non-AC MEC.


CLINICAL TRIAL INFORMATION
NCT01339260; NCT01376297. [Table: see text].