Tesaro Nausea Drug Meets Late Stage Trial Endpoints

Tesaro has announced that its drug treating chemotherapy-induced nausea and vomiting has met company goals in a late stage trial. The drug, rolapitant, achieved statistical significance over traditional therapies in the 532 patients enrolled in the final Phase III study. The drug was generally well tolerated by patients, with the most adverse side effects reported being fatigue, loss of appetite, and constipation. The company’s latest results build on a December study for the drug, which also found that the drug was effective at treating chemotherapy-induced nausea and vomiting.

Rolapitant is a NK-1 receptor antagonist, which works by blocking neurokinin substance P in the brain that stimulates the vomiting reflex. A significant portion —upwards of 70 percent — of chemotherapy patients suffer from nausea and vomiting. For some patients, the nausea can cause the delay of or discontinuation of chemotherapy treatments, along with other unwanted effects such as malnutrition, dehydration, and weight loss.

Tesaro has stated that it is readying a marketing application to the FDA for the treatment, which should be complete by the middle of this year.

Mary Lynee Hedley, PhD and president of Tesaro, says that the company is pleased with the results of the trial and believe that the drug will be a convenient and beneficial treatment option for patients. “In our view, these results describe a differentiated profile for rolapitant. 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 Hedley. She went on to say that the company planned to formally present the results of their research at the upcoming American Society of Clinical Oncology annual meeting.

In 2010, Tesaro acquired the rights to develop and market rolapitant from Opko Health for $121 million.