1 April 2019 - - US-based pharmaceutical company Odonate Therapeutics, Inc. (NASDAQ: ODT) has initiated CONTESSA TRIO, a multi-cohort, multicenter, Phase 2 study of tesetaxel, Odonate's investigational, orally administered taxane, the company said.

In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic TNBC who have not received prior chemotherapy for advanced disease will be randomized 1: 1: 1 to receive tesetaxel plus either nivolumab; pembrolizumab; or atezolizumab.

Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are 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 US Food and Drug Administration as a first-line treatment for patients with metastatic TNBC.

The dual primary endpoints for Cohort 1 are objective response rate and progression-free survival. Secondary endpoints include duration of response and overall survival.

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 HER2 negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy.

The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS.

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.

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.

In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer who have not received prior chemotherapy for advanced disease will be randomised 1: 1: 1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or 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 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 US Food and Drug Administration as a first-line treatment for patients with metastatic TNBC.

The dual primary endpoints for Cohort 1 are objective response rate and progression-free survival. Secondary endpoints include duration of response and overall survival.

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 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.

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.