Wilex reports PFS data for Mesupron in breast cancer

Wilex AG (Xetra:WL6) said first-line treatment with once-daily oral Mesupron plus twice-daily capecitabine led to a median progression-free survival, the primary endpoint, of 8.3 months vs. 7.5 months for capecitabine alone in a Phase II trial to treat HER2-negative metastatic breast cancer. Additionally, Mesupron plus capecitabine led to an objective response rate (ORR) of 17% vs. 9% for capecitabine alone. Overall survival (OS) data, which are not yet mature, are expected in 1H13. Wilex said the trial was not powered to detect statistical significance. In a subgroup of patients who received adjuvant chemotherapy following breast cancer diagnosis, Mesupron plus capecitabine led to a median PFS of 8.3 months vs. 4.3 months for capecitabine alone. The double-blind, international trial enrolled 132 patients. The product is a second-generation serine protease inhibitor targeting urokinase-type plasminogen activator ( uPA). ...