EC145: Additional Phase II data

Additional data from the open-label, international Phase II PRECEDENT trial in 149 patients with platinum-resistant ovarian cancer showed that thrice-weekly 2.5 mg IV EC145 every 2 weeks plus 50 mg/m 2 IV Doxil liposomal doxorubicin every 28 days produced an ORR of 28%, including 28 complete or partial responses, plus 45 cases of stable disease. Doxil alone produced an ORR of 16.2%, including 8 complete or partial responses, plus 18 cases of stable disease. In a subset of patients with 100% folate receptor-positive tumors (n=38), EC145 plus chemotherapy led to a median PFS of 24 weeks vs. 6.6 weeks for chemotherapy alone (p=0.018). Data were presented at the American Society of Clinical Oncology meeting in Chicago.

In April, Endocyte said it plans to submit an MAA to EMA seeking conditional approval of EC145 to treat platinum-resistant ovarian cancer in patients that overexpress folate as identified by its companion diagnostic EC20. The submission will be based on data from the PRECEDENT trial, which previously showed that EC145 plus chemotherapy met the primary endpoint of significantly improving PFS vs. chemotherapy alone (21.7 vs. 11.7 weeks, p=0.031). Previously reported preliminary OS data showed that 81% of patients receiving EC145 plus Doxil were alive at 6 months vs. 72% for Doxil alone (see BioCentury, June 21, 2010; Jan 31; & May 2). ...