) 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/
) 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
& Co. Inc.
) 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 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 (SMDC)
Investors looking for a better stock may consider a company
), which carries a Zacks Rank #1 (Strong Buy).
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