Results of CONTESSA, a Phase 3 Study of Tesetaxel in the Treatment of Patients with Metastatic Breast Cancer, to Be Presented...
05 Octobre 2020 - 2:30PM
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201005005198/en/
Odonate Therapeutics, Inc. John Lemkey Chief Operating Officer
(858) 731-8188 jlemkey@odonate.com
Odonate Therapeutics (NASDAQ:ODT)
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