Endocyte, Inc.’s (ECYT) shares skyrocketed 92.4% with the phase IIb TARGET study evaluating Vynfinit (vintafolide) in non-small cell lung cancer (:NSCLC) patients met its primary endpoint of improved progression free survival (PFS).
Endocyte said that results were statistically significant with a 25% reduction in the risk of disease worsening or death being observed in patients treated with Vynfinit/Sanofi’s (SNY) Taxotere (docetaxel) regimen as compared to Taxotere alone. The secondary endpoints of the study include overall response rate and overall survival (:OS).
Endocyte expects mature OS data by the end of 2014.
In addition, Endocyte and partner Merck & Co. Inc. (MRK) gained a positive opinion in the EU from the Committee for Medicinal Products for Human Use (CHMP) for Vynfinit and companion imaging components (Folcepri and Neocepri) for the treatment of adult patients with FR-positive, platinum-resistant, ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD). Conditional approval should be granted by Jun 2014, which will trigger a milestone payment of $12.5 million to Endocyte.
Endocyte and Merck will initiate a phase II randomized trial on Vynfinit in FR-positive triple negative breast cancer in April or early summer this year.
We note that Endocyte and Merck had entered into a partnership in Apr 2012, wherein Endocyte granted Merck an exclusive license to develop, manufacture and commercialize Vynfinit worldwide. Endocyte has retained the right to co-promote Vynfinit with Merck in the U.S.
Endocyte carries a Zacks Rank #3 (Hold). The PFS data is indeed encouraging. The secondary endpoints also showed trends in favor of the combination arm. Moreover, the combination regimen showed better activity in patients with adenocarcinoma. We are looking forward to seeing OS data later this year. Both news validate the company’s small molecule drug conjugates (SMDCY) platform.
Investors looking for a better stock may consider a company like Alkermes (ALKS), which carries a Zacks Rank #1 (Strong Buy).