Results of CONTESSA, a Phase 3 Study of Tesetaxel in the Treatment of Patients with Metastatic Breast Cancer, to Be Presented at the 2020 San Antonio Breast Cancer Symposium (SABCS)
Odonate Therapeutics announced that results from the CONTESSA Phase 3 study of tesetaxel in metastatic breast cancer will be presented at the 2020 SABCS on December 11, 2020. The study compares tesetaxel with capecitabine in patients with HER2-negative, hormone receptor-positive metastatic breast cancer previously treated with taxane. CONTESSA aims to demonstrate progression-free survival (PFS) and assess secondary endpoints including overall survival (OS) and objective response rate (ORR). Tesetaxel showcases unique pharmacologic advantages, such as oral administration and significant antitumor activity.
- Tesetaxel demonstrated significant single-agent antitumor activity in Phase 2 studies.
- CONTESSA targets an important patient group with unmet medical needs in metastatic breast cancer.
- Presentation at a prestigious conference raises visibility for tesetaxel and Odonate.
- Contingent on the outcome of CONTESSA, with risks of unfavorable results impacting further development.
- Regulatory approval remains uncertain and dependent on clinical outcomes.
SAN DIEGO--(BUSINESS WIRE)--The results of CONTESSA, a Phase 3 study of tesetaxel in the treatment of patients with metastatic breast cancer, have been selected for an oral presentation at the 2020 SABCS, to be held virtually December 8-11, 2020.
The presentation details are as follows:
Date: December 11, 2020
Time: 9:00am CT
Session: General Session 4
Title: Results from CONTESSA: A phase 3 study of tesetaxel plus a reduced dose of capecitabine versus capecitabine alone in patients with HER2-, hormone receptor + (HR+) metastatic breast cancer (MBC) who have previously received a taxane
For more information, please visit https://www.sabcs.org/Program/Daily-Schedule/Day-4.
About Tesetaxel
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. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.
About CONTESSA
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in 685 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive 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 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) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC, and disease control rate (DCR) as assessed by the IRC.
About Odonate Therapeutics, Inc.
Odonate Therapeutics, Inc. is a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. Odonate’s initial focus is on the development of tesetaxel, 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. Odonate’s goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives. To learn more, please visit www.odonate.com.
Forward-looking Statements
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: expectations regarding the outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with metastatic breast cancer; expectations regarding the enrollment, completion and outcome of our other clinical studies; expectations regarding the timing for our planned New Drug Application submission for tesetaxel and 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 with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.
