Odonate Therapeutics Announces Presentation at the American Association for Cancer Research (AACR) Annual Meeting 2019
- In Preclinical Testing, Tesetaxel Brain Concentrations Exceeded Concentrations Required for Tumor Killing for Sustained Period of Time -
Abstract 3078 (Poster Board #12): Tesetaxel,
a novel, oral taxane, crosses intact blood-brain barrier (BBB) at
therapeutically relevant concentrations
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 1
Session Date and Time:
Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies.
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) assessed by the IRC and disease control rate (DCR) assessed by the IRC. To learn more, please visit www.contessastudy.com.
This press release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. We caution
investors that forward-looking statements are based on management’s
expectations and assumptions as of the date of this press release and
involve substantial risks and uncertainties that could cause the actual
outcomes to differ materially from what we currently expect. These risks
and uncertainties include, but are not limited to, those associated
with: the outcome of CONTESSA, our Phase 3 study of tesetaxel in
patients with locally advanced or metastatic breast cancer; our ability
to obtain regulatory approval of tesetaxel; the unpredictable
relationship between preclinical study results and clinical study
results; and other risks and uncertainties identified in our filings
Odonate Therapeutics, Inc.
Chief Operating Officer