Emend Eases Children’s Chemotherapy-Induced Nausea and Vomiting, Study Shows
Merck plans FDA submission in second half of 2014
The addition of Emend (aprepitant, Merck) to a standard treatment regimen significantly reduced chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients in a large phase III trial.
The randomized, double-blind, active-comparator study of 302 participants evaluated Emend for prevention of CINV in children ages 6 months to 17 years of age. Patients receiving emetogenic chemotherapy were randomly assigned to receive an Emend plus ondansetron regimen (n = 152) or a control regimen (placebo plus ondansetron, n = 150).
The Emend regimen included either capsules or an investigational powder for suspension formulation dosed based on weight. Ondansetron was administered at the approved pediatric dose.
The study’s primary endpoint was complete response (CR), defined as no vomiting, retching, or use of rescue medication for nausea and vomiting, in the delayed phase (25 to 120 hours following initiation of chemotherapy). CR was achieved by 51% of patients receiving the Emend regimen versus 26% in the control group (P < 0.0001).
In secondary endpoints, 66% of patients receiving the Emend regimen achieved a CR in the acute phase of CINV (0 to 24 hours) versus 52% receiving the control regimen (P = 0.0135). In addition, CR in the overall phase (0–120 hours) was higher in patients receiving the Emend regimen versus the control regimen (40% versus 20%, P = 0.0002). No vomiting in the overall phase was observed in 47% versus 21% of patients receiving the Emend regimen compared to the control regimen, respectively (P < 0.0001).
Overall, 79% of patients receiving the Emend regimen and 77% receiving the control regimen experienced one or more adverse events. The most common (across all grades) with the Emend regimen compared to the control regimen included anemia (17% versus 25%), febrile neutropenia (16% for both groups), vomiting (15% for both groups), neutropenia (14% versus 12%), thrombocytopenia (10% versus 11%), decreased neutrophil count (9% versus 13%), nausea (9% versus 11%), and a decreased platelet count (8% versus 10%).
The new data were presented at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology Annual International Symposium on Supportive Care in Cancer in Miami, Florida. Based on these data, Merck plans to submit a new drug application (NDA) to the FDA for a pediatric formulation (powder for suspension) and a supplemental NDA for use of the current formulation (capsules) in the second half of 2014.
Emend, a substance p/neurokinin-1 receptor antagonist approved for use in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Source: Merck; June 30, 2014.