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Odonate under pressure on safety profile of lead drug tesetaxel

August 24, 2020

Odonate Therapeutics (NASDAQ:ODT) says that the CONTESSA (Phase 3) trial evaluating lead candidate tesetaxel in metastatic breast cancer (MBC) patients 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.

Risk of disease progression/death was reduced by 28.4% (hazard ratio = 0.716) for tesetaxel + capecitabine, compared to capecitabine alone.

On the safety front, tesetaxel plus capecitabine was associated with a manageable safety profile, although Grade 3 (or higher) neutropenia (low levels of white blood cells) occurred in 71.2% of patients versus 8.35 for capecitabine alone.

Other Grade 3+ treatment-emergent adverse events included diarrhea (13.4% vs. 8.3%), hand-foot syndrome (6.8% vs. 12.2%), febrile neutropenia (12.8% vs. 1.2%) and hypokalemia (8.6% vs. 2.7%).

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.

Overall survival (OS) data were not mature. A final analysis of OS is expected in 2022.

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes.

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