In this open-label, single-arm Phase II trial, women with platinum-resistant ovarian cancer were treated with up to six cycles of NOV-002 and carboplatin. Efficacy endpoints included progression-free survival (PFS) and tumor response rate. Of 15 evaluable patients, 11 had previously failed three lines of chemotherapy, including platinum-based therapy. Tumors were assessed bi-monthly after at least eight weeks of treatment.
Median PFS was 15.4 weeks and mean PFS was 19.4 weeks. These values compare favorably to published data showing a median PFS of eight weeks in this late-stage, platinum-resistant patient population. Furthermore, five out of 15 women treated with NOV-002 and carboplatin had stable disease for five months (20 weeks) or longer.
In terms of best overall tumor response, one patient achieved a partial response, eight stable disease and six progressive disease. Thus, 60% (nine out of 15) women demonstrated clinical benefit and slowing of disease progression with NOV-002 and carboplatin. Hematologic toxicity was mild, suggesting possible mitigating effect of NOV-002. NOV-002 itself was also well-tolerated, further extending the excellent safety profile that NOV-002 has demonstrated in previous studies.
Harry Palmin, president and CEO of Novelos, said: “We are very pleased that NOV-002 continues to demonstrate activity in multiple tumor types, and we look forward to discussing with the FDA a design for a larger multi-center Phase II trial in ovarian cancer.”