ODT - Odonate Therapeutics reports positive late-stage CONTESSA data of Tesetaxel in patients with metastatic breast cancer

Odonate Therapeutics ([[ODT]] -0.8%) announces positive results from a multinational, multicenter, randomized CONTESSA, Phase 3 trial evaluating lead candidate tesetaxel in metastatic breast cancer ((MBC)) patients.The study met the primary endpoint of improved Progression-free Survival ((PFS)), with median PFS of 9.8 months for tesetaxel + reduced dose of capecitabine arm, vs. 6.9 months in approved doses of capecitabine alone, an improvement of 2.9 months.Risk of disease progression/death was reduced by 28.4% (hazard ratio = 0.716) for tesetaxel + capecitabine, compared to capecitabine alone.Other Grade 3+ treatment-emergent adverse events included neutropenia (70.9% vs. 8.3%), diarrhea (13.1% vs. 8.9%), hand-foot syndrome (6.8% vs. 12.2%), febrile neutropenia (13.1% vs. 1.2%), fatigue (8.6% vs. 4.5%, hypokalemia (8.6% vs. 2.7%),leukopenia (9.8% vs. 0.9%); and anemia (8.0% vs. 2.4% ).The discontinuation rates were 4.2% from neutropenia and 3.6% from neuropathy. The overall discontinuation rate was 23.1% in the treatment group compared to 11.9% in the capecitabine alone group.Tesetaxel dose reductions occurred in 76% of patients treated with

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Odonate Therapeutics reports positive late-stage CONTESSA data of Tesetaxel in patients with metastatic breast cancer