BioCentury
ARTICLE | Company News

Endocyte leaps on CHMP nod for vintafolide

March 22, 2014 12:54 AM UTC

Endocyte Inc. (NASDAQ:ECYT) jumped $13.53 (92%) to $28.17 on Friday after EMA's CHMP recommended conditional approval of the company's Vynfinit vintafolide to treat folate receptor-positive platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin. CHMP also backed conditional approval of companion imaging diagnostics Folcepri etarfolatide, a folate-targeted radiopharmaceutical imaging agent, and Neocepri IV folic acid. Merck & Co. Inc. (NYSE:MRK) has exclusive, worldwide rights from Endocyte to develop and commercialize Vynfinit, a folate linked to alkaloid chemotherapy agent desacetylvinblastine monohydrazide.

Separately, Endocyte said Vynfinit plus docetaxel met the primary endpoint of improving progression-free survival (PFS) vs. docetaxel alone in the Phase IIb TARGET trial as second-line treatment of non-small cell lung cancer (NSCLC) (HR=0.75; p=0.0696). The company said the predefined threshold for meeting the endpoint was a p-value of <0.1. Endocyte also said data for secondary endpoints, including overall response rate (ORR) and overall survival (OS), showed trends in favor of the combination arm. Median OS has been reached for the Vynfinit and docetaxel monotherapy arms, but has not yet been reached in the combination arm. The company expects OS data from TARGET to mature later this year. ...