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Odonate Therapeutics Announces Initiation of CONTESSA, a Phase 3 Study of Tesetaxel in Patients with Locally Advanced or Metastatic Breast Cancer

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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 it has initiated CONTESSA,
a multinational, multicenter, randomized, Phase 3 study of tesetaxel in
patients with locally advanced or metastatic breast cancer (MBC).

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. Currently available taxanes must be
delivered intravenously, typically at an infusion center. Tesetaxel has
several potential therapeutic advantages over currently available
taxanes, including oral administration with a low pill burden and a
patient-friendly dosing regimen and a formulation that does not contain
solubilizing agents that are known to cause hypersensitivity (allergic)
reactions. More than 500 patients have been treated with tesetaxel
across 22 clinical studies. In patients with MBC, tesetaxel was shown to
have robust single-agent antitumor activity in two, multicenter, Phase 2
studies.

CONTESSA will compare tesetaxel dosed orally at 27 mg/m2 on
the first day of a 21-day cycle plus a reduced dose of capecitabine
(1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle)
to the approved dose of capecitabine alone (2,500 mg/m2/day
dosed orally on days 1-14 of a 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 an anthracycline
and/or endocrine therapy with or without a cyclin-dependent kinase (CDK)
4/6 inhibitor. The primary endpoint is progression-free survival (PFS)
assessed by an Independent Radiologic Review Committee (IRC). CONTESSA's
secondary efficacy endpoints are overall survival, objective response
rate (ORR) assessed by IRC, disease control rate (ORR + prolonged (≥ 24
weeks) stable disease) assessed by IRC and patient-reported outcomes.

"Despite recent advances in the treatment of advanced breast cancer,
there remains a significant need for new therapies that allow patients
to maintain a better quality of life," said Kevin Tang, Chairman and
Chief Executive Officer of Odonate. "CONTESSA is designed to evaluate
the potential benefit of an all-oral regimen that combines tesetaxel
with a reduced dose of capecitabine as compared to the approved dose of
capecitabine alone, with the goal of establishing a new, all-oral
treatment option with an improved benefit-risk profile."

About Breast Cancer and Its Treatment

Breast cancer is the second most common cancer worldwide, with an
estimated 1.8 million new cases diagnosed per year.1 In
Europe, an estimated 494,000 new cases are diagnosed and approximately
143,000 women will die of the disease each year, making it the leading
cause of cancer death in women.1 In the U.S., an estimated
255,000 new cases are diagnosed and approximately 41,000 women will die
of the disease each year, making it the second-leading cause of cancer
death in women.2 The 5-year survival rate for patients with
metastatic breast cancer is approximately 22%.2

Breast cancer is a heterogeneous disease comprised of several molecular
subtypes, which are commonly grouped into clinical subtypes based on
receptor status. Human epidermal growth factor receptor 2 (HER2)
negative, hormone receptor (HR) positive disease, which represents the
majority of all MBC cases, remains an area of high unmet medical need.
Over the past two decades, only modest survival benefits have been
achieved in this patient population; hence, treatment goals emphasize
controlling disease-related symptoms, minimizing toxicity and maximizing
quality of life.

Patients with HER2 negative, HR positive MBC are typically treated with
endocrine therapy (with or without targeted agents such as a
cyclin-dependent kinase ("CDK") 4/6 inhibitor), chemotherapy, or both.
The recently approved CDK 4/6 inhibitor palbociclib, an orally
administered therapy, has significantly improved outcomes for patients
with MBC when used in combination with endocrine agents. However,
virtually all MBC patients on endocrine therapy will eventually progress
and require subsequent treatment with chemotherapy. Chemotherapy agents
currently available for the treatment of HER2 negative, HR positive MBC,
including the oral agent, capecitabine, and the approved taxanes,
generally are limited by their toxicity and impact on quality of life.

About Taxanes

Taxanes are an established class of anticancer agents that are broadly
used in various cancers, including breast cancer. While paclitaxel and
docetaxel, the first two taxanes approved for the treatment of breast
cancer, possess robust antitumor activity, they have low oral
bioavailability and low solubility. Therefore, these pharmaceutical
agents must be delivered intravenously, typically at an infusion center,
and also are formulated with solubilizing agents that are known to cause
hypersensitivity reactions. Nab-paclitaxel, a different formulation of
paclitaxel that also is approved for the treatment of breast cancer, has
a greatly reduced risk of hypersensitivity reactions, but must still be
delivered intravenously. Therapies given intravenously at an infusion
center often are associated with: fear of needles and complications
associated with venous access; anxiety, including
institutional-triggered side effects such as nausea and vomiting;
heightened awareness of life-threatening disease presence; and
disruption of daily activities.3,4

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 potential therapeutic
advantages over currently available taxanes, including oral
administration with a low pill burden and a patient-friendly dosing
regimen and a formulation that does not contain solubilizing agents that
are known to cause hypersensitivity (allergic) reactions. More than 500
patients have been treated with tesetaxel across 22 clinical studies. In
patients with locally advanced or metastatic breast cancer (MBC),
tesetaxel was shown to have robust single-agent antitumor activity in
two, multicenter, Phase 2 studies.

About CONTESSA

Odonate recently initiated CONTESSA,
a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an
investigational, orally administered taxane, in patients with locally
advanced or metastatic breast cancer (MBC). CONTESSA will compare
tesetaxel dosed orally at 27 mg/m2 on the first day of a
21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day
dosed orally on days 1-14 of a 21-day cycle) to the approved dose of
capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14
of a 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 an anthracycline and/or endocrine
therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor.
The primary endpoint is progression-free survival (PFS) assessed by an
Independent Radiologic Review Committee (IRC). CONTESSA's secondary
efficacy endpoints are overall survival, objective response rate (ORR)
assessed by IRC, disease control rate (ORR + prolonged (≥ 24 weeks)
stable disease) assessed by IRC and patient-reported outcomes. 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. The Company's initial focus is on the
development of tesetaxel, an investigational, orally administered
chemotherapy agent belonging to the taxane class. Odonate recently
initiated CONTESSA, a multinational, multicenter, randomized, Phase 3
study of tesetaxel in patients with locally advanced or metastatic
breast cancer (MBC). 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.

References

1 World Health Organization. http://globocan.iarc.fr/
Last accessed 27 December 2017.
2 American Cancer
Society. https://www.cancer.org/
Last accessed 27 December 2017.
3 Gornas M, Szczylik C.
Oral treatment of metastatic breast cancer with capecitabine: what
influences the decision-making process? European Journal of Cancer
Care
. 2010;19:131-136.
4 Schott S, Schneeweiss A,
Reinhardt J, et al. Acceptance of oral chemotherapy in breast cancer
patients - a survey study. BMC Cancer. 2011;11:129.

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