Tesaro Sees Positive Results in Final Phase 3 Trial of Rolapitant

Tesaro announced positive results from the third and final Phase 3 trial of rolapitant, its drug designed to help prevent chemotherapy side effects.

Rolapitan targets the neurokinin-1 receptor, which plays a role in chemotherapy-induced nausea and vomiting (CINV). The Waltham, MA-based company said the drug hit all the primary and secondary endpoints in the trial, in which 532 patients received cisplatin-based, highly emetogenic chemotherapy along with rolpaitant or the control.

Tesaro said the rolapitant arm of the study achieved statistical significance over the control arm for the primary goal of complete response in the delayed phase of CINV.

The company also said the rolapitant arm was statistically better in preventing nausea in the acute (0 to 24 hours) and overall (0 to 120 hours) phases of CINV. Results for safety and tolerability were similar to the results for those who received the control, Tesaro said.

"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," said Mary Lynne Hedley, Ph.D., president of Tesaro.

The company said it plans to submit an NDA in mid-2014. — Kellen Owings

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