Phase III study of Emend (fosaprepitant dimeglumine) shows benefits in chemotherapy-induced nausea and vomiting-Merck

Merck has announced results from a Phase III study investigating the safety and efficacy of single-dose Emend (fosaprepitant dimeglumine) for Injection, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic (vomit-inducing) chemotherapy (MEC). In the study, the single-dose Emend for Injection regimen provided greater protection from nausea and vomiting following administration of chemotherapy versus an active control of placebo with other anti-vomiting medicines.

For the primary study endpoint, Emend for Injection regimen provided higher incidence of complete response (CR) in days 2 through 5 � with CR observed in 78.9 percent of patients receiving the Emend for Injection regimen versus 68.5 percent in the active control group (p <0.001). for the secondary endpoints, in the acute phase, cr was observed in 93.2 percent of patients receiving the emend for injection regimen versus 91 percent in the active control group (p="0.184)." in the overall phase, the incidence of cr was observed in 77.1 percent of patients receiving the emend for injection regimen versus 66.9 percent in the active control group (p><0.001).>

Additionally, a significantly greater proportion of patients receiving the Emend for Injection regimen experienced no vomiting in the overall phase (82.7 percent with Emend vs 72.9 percent in the active control group) and delayed phase (83.9 percent with Emend vs 75.1 percent in the active control group) (both p <0.001) � with a favorable trend in the acute phase (94.8 percent with emend vs 92 percent in the active control group). the most common adverse events (across all grades) in the emend for injection regimen and active control group included fatigue and diarrhea. these data were presented at the multinational association of supportive care in cancer international society of oral oncology (mascc isoo) annual meeting.>