– Results Presented at the American Association for Cancer
Research (AACR) Annual Meeting 2019 –
ATLANTA–(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 presented results of
preclinical studies of tesetaxel, Odonate’s investigational, orally
administered taxane, at the American Association for Cancer Research
(AACR) Annual Meeting 2019. The presentation is entitled, “Tesetaxel, a
novel, oral taxane, crosses intact blood-brain barrier (BBB) at
therapeutically relevant concentrations” (Poster
Board #12; Abstract 3087).
These preclinical results indicate that, following oral administration,
tesetaxel achieves brain concentrations that exceed concentrations
required for tumor killing for a sustained period of time. This is in
contrast to paclitaxel and docetaxel, the most commonly prescribed
taxanes, which do not substantially cross the BBB.
“The development of effective treatment options for patients with brain
metastases remains an enormous unmet medical need”, said Nancy Lin,
M.D., Associate Chief of Breast Oncology, Susan F. Smith Center for
Women’s Cancers, and Director of the EMBRACE Metastatic Breast Cancer
Program, Dana-Farber Cancer Institute. “Taxanes are one of the most
active and widely used classes of chemotherapy agents for the treatment
of both early stage and metastatic breast cancer, but conventional
taxanes do not cross the blood-brain barrier. The preclinical results
showing tesetaxel penetration across an intact blood-brain barrier are
compelling and raise the potential for both treatment and prevention of
brain metastases. We look forward to investigating the possible
translation of this finding into clinical outcomes in CONTESSA, CONTESSA
2 and CONTESSA TRIO, each of which allows enrollment of patients with
brain metastases.”
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.
About CONTESSA
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 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 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) 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 CONTESSA 2
CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel,
an investigational, orally administered taxane, in patients with locally
advanced or metastatic breast cancer (LA/MBC). CONTESSA 2 is
investigating 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) in approximately 125
patients with human epidermal growth factor receptor 2 (HER2) negative,
hormone receptor (HR) positive LA/MBC not previously treated with a
taxane. 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 objective response
rate (ORR) as assessed by an Independent Radiologic Review Committee
(IRC). The secondary efficacy endpoints are duration of response (DoR)
as assessed by the IRC, progression-free survival (PFS) as assessed by
the IRC, disease control rate (DCR) as assessed by the IRC and overall
survival (OS).
About CONTESSA TRIO
CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of
tesetaxel, an investigational, orally administered taxane, in patients
with locally advanced or metastatic breast cancer (LA/MBC). In Cohort 1,
approximately 90 patients (with potential expansion to up to 150
patients) with locally advanced or metastatic triple-negative breast
cancer (TNBC) who have not received prior chemotherapy for advanced
disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27
mg/m2 on the first day of each 21-day cycle plus either: (1)
nivolumab at 360 mg by intravenous infusion on the first day of each
21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the
first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by
intravenous infusion on the first day of each 21-day cycle. Nivolumab
and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor)
are immuno-oncology (IO) agents approved for the treatment of multiple
types of cancer. One of these agents, atezolizumab, in combination with
the intravenously delivered taxane, nab-paclitaxel, was recently
approved by the U.S. Food and Drug Administration (FDA) as a first-line
treatment for patients with metastatic TNBC. The dual primary endpoints
for Cohort 1 are objective response rate (ORR) and progression-free
survival (PFS). Secondary endpoints include duration of response (DoR)
and overall survival (OS). Efficacy results for each of the three
PD-(L)1 inhibitor combinations will be assessed for correlation with the
results of each of the three approved PD-L1 diagnostic assays. In Cohort
2, approximately 40 elderly patients (with potential expansion to up to
60 patients) with human epidermal growth factor receptor 2 (HER2)
negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2
on the first day of each 21-day cycle. The primary endpoint for Cohort 2
is ORR. Secondary endpoints include PFS, DoR and OS. Patients with
central nervous system metastases are eligible for both cohorts.
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 locally advanced or metastatic breast cancer (LA/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
jlemkey@odonate.com