Facing off rivals, Merck looks to expand CINV label on positive PhIII Emend study

Merck ($MRK) posted another batch of promising Phase III data for Emend (aprepitant), its antivomiting drug for chemo patients. The pharma giant noted that in the study its NK1 receptor agonist scored a statistically significant complete response rate among patients getting a moderately emetogenic (or vomit-inducing) chemotherapy. Merck will now look to broaden its label for the drug for chemotherapy-induced nausea and vomiting (CINV) as it squares off against prospective competitors.

During the acute phase for CINV in the two to 5 days following chemo Emend achieved a complete response rate--meaning no vomiting--for the patients taking Emend in combination with ondansetron and dexamethasone, among 78.9% of the patients in the drug arm. For the control group, which received a placebo plus the two standards, the CR rate was 68.5%.

The secondary endpoints were set for the first 24 hours and the overall 0-120 hour study period. In the first 24 hours the Emend combo barely edged out the standards, 93.2% to 91%. The score was much wider for the overall phase: 77.1% compared to 66.9%.

Emend is already approved for highly emetogenic chemotherapy, or HEC.

Merck has been positioning its drug against Tesaro's rolapitant, which is under review at the FDA. In one of its three Phase III studies for moderately vomit-inducing chemo, rolapitant plus dexamethasone achieved a positive CR rate in the acute (83.5% vs 80.3%) and overall (68.6% vs. 57.8%) phases.

Heron Therapeutics ($HRTX), meanwhile, posted its own positive Phase III for its NK1 receptor antagonist fosaprepitant for HEC patients in March, claiming a 64.7% vs. 56.6% CR rate comparing its therapy against a three-drug combo--ondansetron, fosaprepitant and dexamethasone.

"Nausea and vomiting remain a significant burden for patients receiving chemotherapy and we look forward to submitting these data for EMEND for Injection to the U.S. Food and Drug Administration," said Stuart Green, vice president of clinical research at Merck Research Laboratories. "This study builds on our decade of research for EMEND and Merck's overall commitment to help people with cancer."

- here's the release