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Nausea Drug Rolapitant Shows Promise in Phase III Trials

Complete response achieved in two studies (December 23)

Positive results have been reported from two phase III trials of rolapitant (Tesaro, Inc.), an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The primary endpoint was achieved in each trial, and preparations are being made to submit a new drug application to the FDA.

The first phase III trial of rolapitant was an international, randomized, double-blind, active-controlled study that enrolled 1,369 cancer patients being treated with moderately emetogenic chemotherapy (MEC), approximately half of whom were receiving anthracycline-based treatment for breast cancer. The patients were randomly assigned to receive either a control therapy (a 5-HT3 receptor antagonist plus dexamethasone) or oral rolapitant 200 mg plus control.

The rolapitant arm successfully achieved statistical significance over the control arm for the primary endpoint of a complete response (CR), defined as no vomiting and no use of rescue medication, in the trial’s delayed phase (the 24- to 120-hour period following initiation of chemotherapy). A greater proportion of patients treated with rolapitant achieved a CR in the acute and overall phases and experienced no significant nausea compared with the control arm, although statistical significance was not met for these secondary endpoints.

The second phase III trial of rolapitant was an international, randomized, double-blind, active-controlled study that enrolled 555 patients being treated with highly emetogenic chemotherapy (HEC), defined as regimens that contain cisplatin at a dose equal to or greater than 60 mg/m2. Patients were randomly assigned to receive either a control therapy (a 5-HT3 receptor antagonist plus dexamethasone) or oral rolapitant 200 mg plus control.

Similar to the MEC study, the rolapitant arm in the HEC study successfully achieved 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 achieved a CR in the acute and overall phases and experienced no significant nausea compared with the control arm, although statistical significance was not met for these secondary endpoints.

Source: Tesaro, Inc.; December 23, 2013.

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