Micrograph showing a lymph node invaded by ductal breast carcinoma. Credit: Nephron.

Odonate Therapeutics has initiated the multi-cohort, multi-centre, Phase II CONTESSA TRIO trial of tesetaxel to treat patients with metastatic triple-negative breast cancer (TNBC).

In the first cohort, about 90 patients with locally advanced or metastatic TNBC will be randomised 1:1:1 to receive tesetaxel in combination with any of nivolumab, pembrolizumab or atezolizumab.

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The IO agents Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are approved to treat multiple types of cancer.

Objective response rate (ORR) and progression-free survival (PFS) are the dual primary endpoints for cohort one, while secondary endpoints are the duration of response (DoR) and overall survival (OS).

“This study will investigate the safety and antitumour activity of tesetaxel, an orally administered taxane with a distinct tolerability and pharmacokinetic profile.”

In cohort two, about 40 elderly patients with HER2 negative MBC will be given tesetaxel monotherapy. The primary endpoint for this cohort is ORR, while secondary endpoints include PFS, DoR and OS.

CONTESSA TRIO principal investigator Sara Tolaney said: “Taxane-IO combinations hold great promise for patients living with TNBC.

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“This study will investigate the safety and antitumour activity of tesetaxel, an orally administered taxane with a distinct tolerability and pharmacokinetic profile, in combination with three approved PD-(L)1 inhibitors.

“CONTESSA TRIO also will investigate tesetaxel monotherapy in elderly patients with MBC, a patient population in need of easier-to-take and better-tolerated therapies.”

The investigational, orally-administered chemotherapy agent tesetaxel belongs to a class of drugs known as taxanes that are used in the treatment of cancer.

Atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the US Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC.

In January last year, Odonate started a new Phase III multinational, multicentre, randomised trial of tesetaxel, called CONTESSA, in patients with locally advanced or metastatic breast cancer (MBC).