Endocyte, Inc.
ECYT, a biopharmaceutical company and leader in developing targeted
small molecule drug conjugates (SMDCs) and companion imaging agents for
personalized therapy in cancer and other serious diseases, today announced the
outcomes of the planned independent Data Safety Monitoring Board (DSMB) review
of the interim futility analysis for the Phase 2b TARGET trial with
investigational candidate vintafolide (MK-8109/EC145). The DSMB recommended
the continuation of the vintafolide combination therapy and docetaxel
monotherapy arms of the trial. The DSMB also recommended investigators and
patients be advised that vintafolide monotherapy is not likely to be declared
superior to docetaxel in progression-free survival (PFS) at the end of the
study, and patients currently on vintafolide monotherapy may continue
treatment based on guidance from their investigator. Top-line results from the
TARGET trial are expected in early 2014.
TARGET is being conducted in non-small cell lung cancer (NSCLC) patients with
all lesions expressing the folate receptor (FR100%), as determined by the
investigational companion imaging agent etarfolatide (EC20). This randomized
trial is fully enrolled and included two investigational arms, vintafolide
(MK-8109/EC145) monotherapy and vintafolide in combination with docetaxel,
each of which is compared to a standard of care control arm, docetaxel
monotherapy. The study's primary endpoint is PFS, powered to demonstrate a 50
percent improvement in PFS (hazard ratio of 0.67) compared to the control arm.
Secondary endpoints include the comparison of overall response rate, overall
survival and safety.
"We are very pleased that our combination therapy of vintafolide and docetaxel
successfully passed the pre-defined interim analysis, and we look forward to
announcing the top-line results of this trial early next year," said Binh
Nguyen, M.D., Ph.D., vice president of clinical development at Endocyte. "The
DSMB's recommendation to allow for continued treatment in the vintafolide
single-agent arm enhances our opportunity to gain important information about
single agent efficacy and safety to inform future trials."
Endocyte and partner Merck have accepted the DSMB recommendations and are
informing investigators. This includes guidance that, per study protocol,
investigators are required to follow all patients whether they continue
therapy or not for documentation including overall survival. The companies
remain blinded to the study results.
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