TESARO Announces Successful Achievement of Primary and All Secondary Endpoints in Third and Final Phase 3 Trial of Rolapitant

News | 05. 12. 2014

TESARO

  • Achieved Primary Endpoint of Complete Response (CR) in the Delayed Period (24 to 120 Hours) Following Initiation of Chemotherapy
  • Achieved Key Secondary Endpoints of CR in the Acute and Overall Periods
  • Achieved All Secondary Endpoints, Including No Significant Nausea
  • Adverse Event Profile Consistent with Earlier Clinical Trials
  • New Drug Application (NDA) Submission to U.S. FDA On Track for Mid-2014

WALTHAM, Mass., May 12, 2014 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today 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.