Endocyte presents interim results from phase II trial of EC145 plus Doxil for platinum-resistant ovarian cancer

Jun 7 2010

Endocyte Inc., a company developing targeted small-molecule drug conjugates, will present results of an interim analysis from a randomized phase II clinical trial in women with platinum-resistant ovarian cancer on Sunday (June 6) during the 46th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“These results are important, because the disease rapidly progresses in women who are highly resistant to standard chemotherapy.”

The results of the interim analysis indicate that the investigational agent EC145 plus Doxil® doubled the median progression-free survival compared to Doxil alone, increasing from approximately 3 months to 6 months (hazard ratio of 0.497; p-value of 0.014). The preliminary overall survival analysis also indicates a trend toward benefit in the EC145 plus Doxil arm (hazard ratio of 0.425; p-value2 of 0.064). The interim analysis was based on data from 91 women.

"The combination of EC145 and Doxil is the first treatment in a randomized study to show such a magnitude of improvement in progression-free survival for these women," said Wendel Naumann, M.D., gynecologic oncologist at Carolinas Healthcare System. "These results are important, because the disease rapidly progresses in women who are highly resistant to standard chemotherapy."

Clinical Trial Design

The international, multi-center randomized trial has enrolled approximately 150 women who had received two or fewer prior systemic cytotoxic regimens and had disease that was resistant to platinum therapy. Patients were randomized to receive EC145 (2.5 mg 3 times a week intravenously weeks 1 and 3) plus Doxil (50 mg/m2 intravenously every 28 days) or Doxil alone at the same dose until disease progression or death. Interim analysis results also indicated that the

combination of EC145 plus Doxil was very well tolerated, with no statistical difference between treatment arms with regard to total adverse events or serious adverse events.

"We are particularly pleased with the results of the interim analysis," said Richard Messmann, M.D., vice president of medical affairs at Endocyte. "Enrollment in this phase II trial is now complete and we look forward to reporting the final results of the study in early 2011 and beginning the phase III study later this year."