The share price of Endocyte, Inc. (ECYT) gained 11.6% after the company along with its partner Merck & Co. Inc. (MRK) published favorable data on vintafolide from a phase II study, PRECEDENT, in the Journal of Clinical Oncology (:JCO).
The results formed the basis of regulatory application of vintafolide in the EU for treating folate-receptor positive platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin (PLD).
The international, multi-center, randomized, phase II study enrolled 149 women with platinum-resistant ovarian cancer. The study evaluated vintafolide in combination with PLD versus PLD alone. The study revealed a median progression-free survival (PFS) of 5.0 months in the vintafolide plus PLD arm compared to 2.7 months for those treated with PLD alone. While PFS was the primary endpoint of the study, response rate and overall survival were the secondary endpoints.
Data also revealed that the combination of vintafolide and PLD was well tolerated. As per information provided by Endocyte, roughly 22,240 new cases of ovarian cancer in the U.S. and over 40,000 new cases in the EU are anticipated in 2013.
Vintafolide is currently being evaluated in a phase IIb TARGET trial in non-small cell lung cancer patients and a phase III PROCEED trial in women with platinum resistant ovarian cancer along with diagnostic imaging agent, etarfolatide. Endocyte also anticipates starting a randomized phase II study of vintafolide soon, in folate receptor-positive triple negative breast cancer.
Endocyte and Merck entered into a partnership in Apr 2012 regarding vintafolide. 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.