A phase III trial of rolapitant, an investigational neurokinin-1 receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting, was successful in achieving statistical significance for its primary and all secondary endpoints.
The trial enrolled patients receiving cisplatin-based, highly emetogenic chemotherapy. The international, multicenter, randomized, double-blind, active-controlled study enrolled 532 cancer patients receiving chemotherapy regimens at a dose equal to or greater than 60 mg/m2.
Patients were randomized to receive either control, which consisted of a 5-HT3 receptor antagonist plus dexamethasone, or 200 milligrams of oral rolapitant plus control. The rolapitant arm in this study successfully achieved statistical significance over the control arm for the primary endpoint of complete response in the delayed phase of CINV.
In addition, the rolapitant arm also successfully achieved statistical significance over the control arm for the key secondary endpoints of CR in the acute and overall phases of CINV, for the secondary endpoint of no significant nausea, and for all other secondary endpoints.
Tesaro Inc., the drug’s sponsor, plans to submit a new drug application to the FDA in mid-2014. Rolapitant is an investigational agent and has not been approved by the FDA or any regulatory agencies.
