Tesaro put the last piece of its Phase III puzzle into place for rolapitant, its experimental therapy for preventing some nasty side effects of chemo, avoiding a repeat of an earlier setback as investors frowned over some missed secondary endpoints. In its final roll of the late-stage dice, the biotech says its drug hit all the primary and secondary goals, helping boost its stock today. The last of three Phase III trials leaves Tesaro on track to deliver an NDA to the FDA in the next few months, but analysts are likely to continue to scratch their heads over its market potential in comparison with a rival therapy from Merck ($MRK) already on the market.
Investigators at Waltham, MA-based Tesaro ($TSRO) have been studying rolapitant for CINV: chemotherapy-induced nausea and vomiting. The drug hit the marks on delayed CINV for the primary as well as avoiding nausea for a key secondary endpoint. The drug's failure to hit secondary endpoints in an earlier Phase III study ended up damaging the biotech's stock as analysts wondered how well the drug might stack up against Merck's Emend, which earned $507 million last year.
Tesaro recruited 532 patients for this study, bringing the total number of patients in its development program to more than 2,500. The drug targets the NK-1 receptor, which plays a role in vomiting and nausea. It was up against a 5-HT3 antagonist in the study, a long-standing standard approach, though Merck's Emend is another NK-1 therapy.
As far as Tesaro is concerned, though, it's all good. And most investors seemed to agree. Its stock shot up 20% this morning.
"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 Mary Lynne Hedley, the president of Tesaro. "We are very pleased with these data, and we look forward to presenting the detailed results of this trial, together with the results of our prior to Phase III trials, at the upcoming American Society of Clinical Oncology annual meeting."
- here's the release