Tesaro: Rolapitant Meets Primary Endpoint In Each Of Two Phase 3 Trials

(RTTNews) - Tesaro Inc. (TSRO), Monday said that its two Phase 3 trials of rolapitant met the primary endpoints. Rolapitant is an investigational neurokinin-1 receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting.

The first Phase 3 study of rolapitant enrolled 1,369 cancer patients receiving moderately emetogenic chemotherapy or MEC, about half of whom were receiving anthracycline-based treatment for breast cancer. Rolapitant arm successfully achieved statistical significance over the control arm for the primary endpoint of complete response, defined as no vomiting and no use of rescue medication, in the delayed phase. The second Phase 3 study enrolled 555 patients receiving highly emetogenic chemotherapy or HEC, defined as regimens which contain cisplatin at a dose equal to or greater than 60 mg/m2. The rolapitant arm successfully met statistical significance over the control arm for the primary endpoint of CR in the delayed phase of CINV.

A greater proportion of patients treated with rolapitant in these trials achieved a CR in the acute and overall phases and experienced no significant nausea compared to the control arm, although statistical significance was not met for these secondary endpoints.

The company continues to enroll patients receiving HEC in a third and final Phase 3 trial of rolapitant, and preparations in support of a mid-2014 NDA submission for oral rolapitant are ongoing.