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The Adverse Event Profile for Rolapitant was Consistent with Earlier Clinical Trials. Preparations Continue in Support of Submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration in Mid-2014.
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TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced top-line results for two Phase 3 trials of rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV).
The primary endpoint was successfully achieved in each trial and preparations are ongoing in support of a New Drug Application (NDA) submission for oral rolapitant to the U.S. FDA.
Three years ago, in December 2010, Tesaro signed a marketing rights agreement with Opko Health Inc. (NYSE: OPK; TASE: OPK) which developed the drug. Opko CEO and chairman is Phillip Frost who serves also chairman of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE:TEVA).
Accotding to “Globes” on the surface this should be good news for Opko which has already received a $121 million milestone payment and stands to gain royalties from any future sales of the drug. “But market sources have reservations about these latest results and are skeptical that Tesaro will gain marketing approval or indeed whether the drug has any advantages over existing treatments”.
“Despite the availability of preventative therapies and established treatment guidelines for CINV, a significant number of cancer patients still suffer from the debilitating side effects of delayed nausea and vomiting, ” said Mary Lynne Hedley, Ph.D., President of TESARO. “We are enthusiastic about the potential for this product candidate, with a profile that may include an extended half life, convenient, single-dose oral and intravenous formulations and a lack of CYP3A4-mediated drug interactions.”
The Study
The first Phase 3 study of rolapitant was an international, multicenter, randomized, double-blind, active-controlled study that enrolled 1, 369 cancer patients receiving moderately emetogenic chemotherapy (MEC), approximately half of whom were receiving anthracycline-based treatment for breast cancer. 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 successfully achieved statistical significance over the control arm for the primary endpoint of complete response (CR), defined as no vomiting and no use of rescue medication, in the delayed phase (the 24 to 120 hour period following initiation of chemotherapy). A greater proportion of patients treated with rolapitant in this trial 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 second Phase 3 study of rolapitant was an international, multicenter, randomized, double-blind, active-controlled study that enrolled 555 patients receiving highly emetogenic chemotherapy (HEC), defined as regimens which contain cisplatin at a dose equal to or greater than 60 mg/m2. Patients were randomized to receive either control, which consisted of 5-HT3 receptor antagonist plus dexamethasone, or 200 milligrams of oral rolapitant 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 in this trial 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.
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, alopecia and loss of appetite.
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