BioCentury
ARTICLE | Clinical News

Tesaro slides on CINV data for oral rolapitant

December 24, 2013 12:12 AM UTC

Tesaro Inc. (NASDAQ:TSRO) fell $9.33 (25%) to $28.37 on Monday after reporting data from a pair of double-blind Phase III trials evaluating oral rolapitant ( SCH 619734) to prevent chemotherapy-induced nausea and vomiting (CINV) showing the compound was effective in the delayed phase of CINV but not effective in the acute phase. In the trials, 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 from more than 24 hours to 120 hours following initiation of chemotherapy vs. granisetron and dexamethasone alone. However, the rolapitant arm missed 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. One trial enrolled 1,369 patients receiving moderately emetogenic chemotherapy (MEC), while the other enrolled 555 patients receiving highly emetogenic chemotherapy (HEC). ...