Independent Data Monitoring Committee (IDMC) Recommends CONTESSA Continue with No Modifications following Planned Interim Efficacy Futility Analysis

SAN DIEGO–(BUSINESS WIRE)–Odonate
Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated
to the development of best-in-class therapeutics that improve and extend
the lives of patients with cancer, today announced that the IDMC for
CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential
treatment for patients with HER2 negative, hormone receptor positive
metastatic breast cancer, recommended that the study continue with no
modifications following a planned interim efficacy futility analysis.
The interim efficacy futility analysis was based on a pre-specified
analysis of the first approximate 100 progression-free survival (PFS)
events that occurred in the study. PFS is the primary endpoint of
CONTESSA. The purpose of the interim efficacy futility analysis was to
facilitate the early termination of the study if the IDMC determined
that achieving a positive outcome on the primary endpoint would be
futile. Odonate continues to expect to complete enrollment of CONTESSA
in the second half of 2019 and to report topline results in 2020.

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 multiple 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 approximately 600 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). CONTESSA’s 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. To learn
more, please visit www.contessastudy.com.

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: the expected outcome of CONTESSA, our Phase 3 study of tesetaxel
in patients with metastatic breast cancer (MBC); the expected outcome of
our other clinical studies, including CONTESSA 2 and CONTESSA TRIO; 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.

Contacts

Odonate Therapeutics, Inc.
John Lemkey
Chief Operating Officer
858-731-8180
[email protected]