Endocyte, Inc.'s (ECYT) pipeline candidate, vintafolide is being evaluated in a phase IIb TARGET trial in non-small cell lung cancer (:NSCLC) patients and a phase III PROCEED trial in women with platinum resistant ovarian cancer along with diagnostic imaging agent, etarfolatide.
Endocyte announced review results of the interim futility analysis for the TARGET study on vintafolide by an independent Data Safety Monitoring Board (:DSMB). The DSMB suggested the continuation of the vintafolide combination therapy and Sanofi’s (SNY) Taxotere monotherapy arms of the study.
DSMB also recommended that the patients treated with vintafolide alone won't have greater progression free survival than patients treated with Taxotere. Patients currently on vintafolide monotherapy may however continue with their treatment based on guidance from the investigator.
Top-line data from the study is expected in early 2014.
In 2012, Endocyte submitted a marketing application seeking approval for vintafolide for platinum-resistant ovarian cancer in the EU. Endocyte is also seeking EU approval for etarfolatide along with vintafolide. Both candidates were granted orphan drug status in the EU in 2012.
Endocyte and Merck & Co. Inc. (MRK) entered into a partnership in Apr 2012, where Endocyte granted Merck an exclusive license to develop, manufacture and commercialize vintafolide outside the U.S. In the U.S. the two companies will co-promote vintafolide following its approval.
Endocyte currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on the regulatory status of vintafolide and etarfolatide Currently, Isis Pharmaceuticals, Inc. (ISIS) looks more attractive with a Zacks Rank #1 (Strong Buy).