Odonate Reports Clinically Meaningful PFS Improvement In CONTESSA Study Of Tesetaxel

(RTTNews) - Odonate Therapeutics, Inc. (ODT) reported positive top-line results from CONTESSA, a Phase 3 study of tesetaxel in patients with metastatic breast cancer. CONTESSA met the primary endpoint of improved progression free survival. While overall survival data are not mature, a recent interim analysis indicated the absence of an adverse effect, the company noted. A final analysis of overall survival is expected to occur in 2022.

The company plans to submit a New Drug Application for tesetaxel to the FDA in mid-2021.

Shares of Odonate Therapeutics were up 8% in pre-market trade on Monday.