Sunesis Pharmaceuticals, Inc. has announced a presentation of updated interim results from an ongoing Phase 2 clinical trial demonstrating that the Company's lead product candidate, voreloxin, shows promising efficacy and safety as a single agent in patients with platinum-resistant ovarian cancer.
Ovarian cancer remains an unmet medical need with high recurrence rates, and the majority of patients ultimately become resistant to platinum-based therapies. These data show encouraging durable anti-tumor activity in the 48 mg/m2 cohort, as measured by partial and complete responses, and preliminary progression-free survival (PFS). Voreloxin has been generally well tolerated at dose levels of 48 mg/m2 and 60 mg/m2.
"Voreloxin continues to demonstrate promising clinical activity in a vastly underserved patient population," said William McGuire, M.D., Medical Director of the Harry and Jeanette Weinberg Cancer Institute at Franklin Square and principal investigator for the Phase 2 clinical trial. "I am encouraged by the preliminary data from the 48 mg/m2 cohort. When compared to other commercially available drugs that are used in the platinum-resistant setting, voreloxin has a similar response rate and a reasonable toxicity profile."
"The preliminary data from the 60 mg/m2 cohort suggests activity similar to that of the 48 mg/m2 cohort. This is expected since the weekly dose intensity is approximately the same. We are encouraged by the pace of enrollment in the 75 mg/m2 cohort and anticipate initial response and safety data from this cohort in the spring of next year," said Dr. Mary Bolton, Vice President, Clinical Development at Sunesis.
The ongoing Phase 2 trial is an open-label, multi-center study of voreloxin as a single agent in recurrent ovarian cancer patients who have platinum-resistant disease, defined as progression within six months of completing platinum-based chemotherapy or progression while on platinum-based therapy. To date, over 120 patients have enrolled in the trial, with enrollment completed in the 48 mg/m2 cohort dosed every three weeks and the 60 mg/m2 cohort dosed every four weeks. In the 48 mg/m2 cohort, of the 65 women evaluable for best response using GOG-RECIST criteria, two patients had a complete response, five patients had partial responses and 46 patients achieved stable disease. Thirty patients (46%) achieved disease control, defined as stable disease for 90 days or more or a complete or partial response. The preliminary median PFS was 82 days, or 11.7 weeks, at the 48 mg/m2 dose. Six patients remain on study in this dose cohort.