CHICAGO ― NEPA, a targeted antiemetic combination therapy that contains netupitant and palonosetron, offers patients with cancer improved relief from chemotherapy-induced nausea and vomiting, compared to palonosetron alone, report authors of a randomized double-blind, parallel-group phase 3 study presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.
“NEPA, a novel single-day fixed-dose combination targeting dual antiemetic pathways, is superior to PALO (palonosetron alone),” Matt S. Aapro, MD, of the Clinique de Genolier in Genolier, Switzerland, and coauthors, reported.
Management of chemotherapy-induced nausea and vomiting has evolved over recent decades, and “can now be addressed with targeted prophylactic medications aimed at inhibiting the molecular pathways involved in emesis, including serotonin receptor antagonists (RAs) and neurokinin-1 (NK1) receptor antagonists,” Dr. Aapro and coauthors reported.
However, adherence to antiemetic guidelines remains poor, resulting in unnecessary nausea and vomiting, “particularly during the delayed phase after chemotherapy,” they noted. NEPA was developed “to provide guideline-based targeted antiemetic prophylaxis in a single oral dose,” Dr. Aapro explained. NEPA is a fixed-dose, synergistic combination of the new NK1 blocker netupitant (NETU 300 mg) and palonosetron (PALO 0.5 mg), a pharmacologically distinct 5-HT.
A total of 1,455 chemotherapy-naïve patients undergoing anthracycline-based chemotherapy were randomly assigned to receive dexamethasone plus either NEPA or PALO. NEPA or PALO were taken orally one hour before chemotherapy and dexamethasone was taken 30 minutes prior to chemotherapy.
NEPA exhibited superior rates of complete acute (0-24 hour post-chemotherapy) and delayed (25-120 hours post-chemotherapy) antiemetic response (no emesis and no rescue medication; P=0.047 and P=0.001, respectively), Dr. Aapro and coauthors reported.
“NEPA was also superior to PALO during the delayed/overall phases for complete protection, no emesis, and no significant nausea,” they noted. “The type and frequency of adverse events were comparable between NEPA and PALO.”
The most common NEPA-related adverse events were headache (3.3%) and constipation (2.1%).
NEPA “has the potential to improve chemotherapy-induced nausea and vomiting control for patients,” they concluded.