Tesaro Reports Positive Results From Final Phase 3 Trial Of Rolapitant

(RTTNews) - Opko Health Inc(OPK) said Monday its licensee, Tesaro Inc (TSRO), announced positive top-line results from the third and final Phase 3 trial of rolapitant - an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV).

The rolapitant arm in this trial, which enrolled patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC), successfully achieved statistical significance over the standard therapy arm for the primary and all secondary endpoints.

The adverse event profile for rolapitant remains consistent with that seen in previous clinical studies.

The third Phase 3 study of rolapitant was a randomized, double-blind, active-controlled study that enrolled 532 cancer patients receiving cisplatin-based 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 (CR) in the delayed phase of CINV.

Safety and tolerability data for patients who received rolapitant were similar to the results for those who received control, and were consistent with earlier clinical studies. The most frequently observed adverse events were balanced across treatment arms and included fatigue, constipation and loss of appetite.

Tesaro continues preparations in support of a submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration in mid-2014.