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

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 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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