CONTESSA Achieved Primary Endpoint – Tesetaxel
Plus a Reduced Dose of Capecitabine Significantly Improved
Progression-free Survival (PFS) Versus the Approved Dose of
Capecitabine Alone (Hazard Ratio=0.716; p=0.003)
Median PFS Was 9.8 Months for Tesetaxel Plus a
Reduced Dose of Capecitabine Versus 6.9 Months for the Approved
Dose of Capecitabine Alone, an Improvement of 2.9 Months
Company to Host Virtual Investor and Analyst
Event Today at 1:00 p.m. CT / 2:00 p.m. ET
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 positive results from CONTESSA, a Phase 3 study of
tesetaxel in patients with metastatic breast cancer (MBC), were
presented in an oral presentation at the 2020 San Antonio Breast
Cancer Symposium (SABCS). The results were presented by Joyce
O’Shaughnessy, M.D., Celebrating Women Chair in Breast Cancer
Research, Baylor University Medical Center, Texas Oncology and
Chair, Breast Cancer Research, US Oncology, and Co‑Principal
Investigator of CONTESSA (please click here for slides).
CONTESSA is a multinational, multicenter, randomized, Phase 3
study of tesetaxel, an investigational, orally administered taxane,
in patients with 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 hormone receptor (HR)-positive,
human epidermal growth factor receptor 2 (HER2)-negative 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 the 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. CONTESSA is being conducted at 180 investigational sites
in 18 countries in North America, Europe and Asia.
CONTESSA met the primary endpoint of improved PFS as assessed by
the IRC. Median PFS was 9.8 months for tesetaxel plus a reduced
dose of capecitabine versus 6.9 months for the approved dose of
capecitabine alone, an improvement of 2.9 months. The risk of
disease progression or death was reduced by 28.4% [hazard
ratio=0.716 (95% confidence interval: 0.573-0.895); p=0.003] for
tesetaxel plus a reduced dose of capecitabine versus the approved
dose of capecitabine alone.
The ORR as assessed by the IRC was 57% for tesetaxel plus a
reduced dose of capecitabine versus 41% for the approved dose of
capecitabine alone (p=0.0002). The DCR as assessed by the IRC was
67% for tesetaxel plus a reduced dose of capecitabine versus 50%
for the approved dose of capecitabine alone (p<0.0001). While OS
data are immature, a recent interim analysis indicated the absence
of an adverse effect on OS with tesetaxel plus a reduced dose of
capecitabine. A protocol‑specified final analysis of OS is expected
to occur in 2022.
Tesetaxel plus capecitabine was associated with a manageable
side effect profile consistent with findings from previous clinical
studies. Grade ≥3 treatment-emergent adverse events (TEAEs) that
occurred in ≥5% of patients were: neutropenia (70.9% for tesetaxel
plus capecitabine vs. 8.3% for capecitabine alone); diarrhea (13.1%
for tesetaxel plus capecitabine vs. 8.9% for capecitabine alone);
hand‑foot syndrome (6.8% for tesetaxel plus capecitabine vs. 12.2%
for capecitabine alone); febrile neutropenia (13.1% for tesetaxel
plus capecitabine vs. 1.2% for capecitabine alone); fatigue (8.6%
for tesetaxel plus capecitabine vs. 4.5% for capecitabine alone);
hypokalemia (8.6% for tesetaxel plus capecitabine vs. 2.7% for
capecitabine alone); leukopenia (9.8% for tesetaxel plus
capecitabine vs. 0.9% for capecitabine alone); and anemia (8.0% for
tesetaxel plus capecitabine vs. 2.4% for capecitabine alone).
Adverse events resulting in treatment discontinuation in ≥1% of
patients were: neutropenia or febrile neutropenia (4.2% for
tesetaxel plus capecitabine vs. 1.5% for capecitabine alone);
neuropathy (3.6% for tesetaxel plus capecitabine vs. 0.3% for
capecitabine alone); sepsis or septic shock (1.8% for tesetaxel
plus capecitabine vs. 0.6% for capecitabine alone); diarrhea (0.9%
for tesetaxel plus capecitabine vs. 1.5% for capecitabine alone);
and hand-foot syndrome (0.6% for tesetaxel plus capecitabine vs.
2.1% for capecitabine alone). Treatment discontinuation due to any
adverse event occurred in 23.1% of patients treated with tesetaxel
plus capecitabine versus 11.9% of patients treated with
capecitabine alone.
Tesetaxel dose reductions occurred in 76% of patients treated
with tesetaxel plus capecitabine, primarily due to neutropenia.
Dose reductions occurred in 61% of patients treated with
capecitabine alone, primarily due to hand-foot syndrome. The
relative delivered dose intensity, which accounts for not only the
frequency, but also the magnitude of reductions and treatment
adherence, was higher in patients treated with tesetaxel plus
capecitabine. Specifically, 81% of the intended dose of tesetaxel
through cycle 12 was delivered in patients treated with tesetaxel
plus capecitabine versus 76% of the intended dose of capecitabine
through cycle 12 in patients treated with capecitabine alone.
Grade 2 alopecia (hair loss) occurred in 8.0% of patients
treated with tesetaxel plus capecitabine versus 0.3% of patients
treated with capecitabine alone. Grade ≥3 neuropathy occurred in
5.9% of patients treated with tesetaxel plus capecitabine versus
0.9% of patients treated with capecitabine alone. There were no
treatment-related hypersensitivity reactions.
“Tesetaxel represents a potential important clinical advance for
patients with metastatic breast cancer,” said Joyce O’Shaughnessy,
M.D. “There remains a significant unmet medical need for novel
therapies that offer quality‑of‑life advantages for patients with
metastatic breast cancer.”
“The PFS improvement observed in CONTESSA, along with
once‑every‑three‑weeks oral dosing and low rates of clinically
significant hair loss and neuropathy, could make tesetaxel an
important new treatment option for patients with metastatic breast
cancer,” said Andrew Seidman, M.D., Medical Director, Bobst
International Center, Memorial Sloan Kettering Cancer Center and
Professor of Medicine, Weill Cornell Medical College, and
Co‑Principal Investigator of CONTESSA.
“We would like to thank all of the investigators, study team
personnel, and especially the patients and their caregivers who
made CONTESSA possible,” said Kevin Tang, Chief Executive Officer
of Odonate. “We look forward to working closely with global
regulatory authorities to make tesetaxel available to patients with
metastatic breast cancer. We plan to submit a New Drug Application
for tesetaxel to the FDA in mid‑2021.”
The Company will host a Virtual Investor and Analyst Event today
at 1:00 p.m. CT / 2:00 p.m. ET.
Virtual Investor and Analyst Event Information
Date: December 11, 2020 Time: 1:00 p.m. CT / 2:00 p.m. ET
Webcast Link: Please click here Dial-in (domestic): (866) 300-4090
Dial-in (international): (636) 812‑6660 Conference ID: 8698553
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. Positive results of CONTESSA were
recently presented at the 2020 San Antonio Breast Cancer
Symposium.
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 hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)‑negative 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; expectations regarding 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201211005106/en/
Company Contact
Odonate Therapeutics, Inc. Michael Hearne Chief Financial
Officer (858) 281-5366 mhearne@odonate.com
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