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Odonate begins phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer

San Diego
Tuesday, January 2, 2018, 11:00 Hrs  [IST]

Odonate Therapeutics, a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, 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 antitumour 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.”

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.

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.

 

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