Tesaro gains on final Phase III data for oral rolapitant

Tesaro Inc. (NASDAQ:TSRO) jumped $5.04 (21%) to $29.05 on Monday after reporting data from its third and final Phase III trial of oral rolapitant to prevent chemotherapy-induced nausea and vomiting (CINV) and reiterated its plans to submit an NDA to FDA by mid-year for the product. In the trial, oral rolapitant plus granisetron and dexamethasone met the primary endpoint of improving complete response rate -- defined as no emetic episodes and no rescue medication -- in the delayed phase of CINV starting 24 hours to 120 hours following initiation of chemotherapy vs. granisetron and dexamethasone alone. The rolapitant arm also met the secondary endpoints of improving complete response rates in the acute (0 to 24 hours) and overall (0 to 120 hours) phases of CINV compared to the control arm. The double-blind, international trial enrolled 532 cancer patients receiving highly emetogenic chemotherapy (HEC). ...