- Results from a Phase 3 trial evaluating Merck's (NYSE:MRK -1%) EMEND (fosaprepitant dimeglumine) for injection, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic (vomit inducing) chemo (MEC) met its primary endpoint of a statistically significant improvement in the control of CINV versus placebo. The data were presented at the Multinational Association of Supportive Care/International Society of Oral Oncology Annual Meeting on Supportive Care in Cancer in Copenhagen, Denmark.
- The study assessed a single 150 mg injection of EMEND plus ondansetron (16 mg) and dexamethasone (20 mg) versus placebo plus ondansetron and dexamethasone administered on day one. The primary endpoint was complete response (CR) (no vomiting and no rescue medications) in the delayed phase (25 to 120 hours after the initiation of chemo). CR in the test group was 78.9% compared to 68.5% for control (p<0.001). In the acute phase (0 to 24 hours after the start of chemo), CR in the EMEND arm failed to reach statistical significance (p=0.184). In the overall phase (0 to 120 hours), CR in the AMEND group was statistically superior to placebo, 82.7% vs. 72.9% (p<0.001).
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EMEND, a substance P/Neurokinin -1 receptor antagonist, is currently cleared in the U.S., in combination with other antiemetic agents, for the prevention of CINV in patients receiving highly emetogenic chemo. Merck intends to submit a supplemental New Drug Application (sNDA) to the FDA for the expanded use of EMEND to prevent CINV in MEC later this year.