ODT - Odonate announces positive Phase 3 data in metastatic breast cancer

In a presentation at the 2020 San Antonio Breast Cancer Symposium, Odonate Therapeutics (ODT) announced positive Phase 3 clinical trial data for tesetaxel, its therapeutic candidate for metastatic breast cancer. The multinational, multicenter, randomized, Phase 3 study, conducted in North America, Europe, and Asia, evaluates orally dosed tesetaxel plus a reduced dose of capecitabine against the approved dose of capecitabine alone in 685 patients.Achieving the primary endpoint, tesetaxel plus the reduced dose of capecitabine (Median PFS: 9.8 Months) significantly improved the progression-free survival compared to the approved dose of capecitabine (Median PFS: 6.9 Months) with an improvement of 2.9 months.With a manageable side effect profile consistent with findings from previous clinical studies, tesetaxel and capecitabine combination reduced the risk of disease progression or death by 28.4% [hazard ratio=0.716 (95% confidence interval: 0.573-0.895); p=0.003] versus the approved dose of capecitabine alone.“The PFS improvement observed in CONTESSA, along with once?every?three?weeks oral dosing

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Odonate announces positive Phase 3 data in metastatic breast cancer