EntreMed Inc., a clinical stage pharmaceutical company developing therapeutics for the treatment of cancer announced the final data for the primary endpoint of progression free survival rate at 6 months for its phase II study with ENMD-2076 in platinum-resistant ovarian cancer patients. Data from all 64 patients showed a six-month progression free survival rate of 22 per cent. Four patients achieved a partial response as measured by RECIST v1.1. Median overall survival has not yet been reached. The side effect profile was consistent with activity against ENMD- 2076’s targets, in particular, VEGFR2 and Aurora A.
The study was conducted at 6 major cancer centres across the United States and Canada and the subject of a presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting held June 3 - 7, 2011 in Chicago, Illinois.
The study was an open-label, single-arm, multi-centre-study of 64 patients receiving ENMD-2076 dosed orally as a single agent in patients with platinum-resistant recurrent ovarian, peritoneal or tubal cancer. The primary endpoint for the study was progression-free survival rate at six months. Secondary end-points include safety, response rate, duration of response, and overall survival.
EntreMed’s chief medical officer, Carolyn F Sidor, MD, MBA, added, “These results show an increase in the reported progression free survival rate over the presentation of interim data at ASCO and are very encouraging. We continue to collect data on overall survival and other endpoints. We believe that ENMD-2076 has made an impact on a number of patients with resistant ovarian cancer who have few therapeutic options.”
ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase. Aurora kinases are key regulators of mitosis (cell division), and are often over- expressed in human cancers. ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases which have been shown to play important roles in the pathology of several cancers. ENMD- 2076 has shown promising activity in phase I clinical trials in solid tumour cancers, leukaemia, and multiple myeloma. ENMD-2076 is currently in a phase II trial for ovarian cancer, and preclinical and clinical activities are ongoing in assessing the compound’s applicability for other forms of cancer.