Mesupron: Phase II data

A double-blind, international Phase II trial in 132 patients with HER2-negative metastatic breast cancer showed that first-line treatment with once-daily oral 200 mg Mesupron plus twice-daily Xeloda capecitabine led to a median PFS, the primary endpoint, of 8.3 months vs. 7.5 months for placebo plus Xeloda. Additionally, Mesupron plus Xeloda led to an ORR of 17% vs. 9% for Xeloda alone. 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 (n=95), Mesupron plus Xeloda led to a median PFS of 8.3 months vs. 4.3 months for Xeloda alone. Mesupron plus Xeloda was well tolerated. ...