Investors pummeled Tesaro in December when an anti-nausea drug it’s been developing for cancer patients missed some key secondary goals in the first two of three late-stage trials. But today the Waltham, MA-based company bounced back when it said a third trial came through unscathed.
Tesaro (NASDAQ: TSRO) said today that rolapitant, a drug it’s developing for chemotherapy-induced nausea and vomiting, hit all of its primary and secondary goals in a third and final Phase 3 study. Tesaro didn’t give any specific numbers, though; it’ll release those data at the American Society of Clinical Oncology’s annual meeting later this month. And Tesaro will incorporate the trial into the package it aims to submit to the FDA in mid-2014.
Shares of Tesaro jumped about 15 percent in early trading Monday.
Tesaro released the top-line data from the first two Phase 2 trials in December. The company said that rolapitant hit its primary goal—patients taking its drug in each of the two trials didn’t vomit or need rescue medication in the “delayed” phase, or between 24 and 120 hours after starting chemotherapy. Even so, Tesaro’s drug whiffed on two secondary measures. It didn’t produce a statistically significant improvement for patients in the acute phase of chemotherapy (beginning minutes to hours after starting, and lasting up to 24 hours) or overall. Shares plummeted by more than 20 percent on the news.
In the latest trial, though, rolapitant didn’t miss, according to Tesaro. The primary goal was to keep cancer patients from vomiting in the delayed phase after starting chemotherapy. Tesaro said rolapitant hit that goal, and also hit statistical significance in all the secondary measures that it missed on in its other two study arms, including reducing rates of “significant nausea.”
If the FDA ultimately approves rolapitant, the drug will compete with a number of other medications for chemo-induced nausea, including Merck’s aprepitant (Emend). Many of those treatments are generic, but Tesaro believes that rolapitant can differentiate itself from the competition.
“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 Tesaro president Mary Lynne Hedley, in a statement.
Tesaro was founded in 2010 by a group of drug developers that helped sell MGI Pharma to Japan-based Eisai for $3.9 billion in 2008. The concept behind the company was to snap up cancer drug candidates discovered by others and develop them. Tesaro, for instance, acquired rolapitant from Opko Health in 2010. The drug is its most advanced prospect.