CONTESSA: Oral Taxane Meets Primary Endpoint

Kathy D. Miller, MD


January 06, 2021

This transcript has been edited for clarity.

Hi. It's Dr Kathy Miller with more exciting news from the San Antonio Breast Cancer Symposium. I'm talking about the use of oral taxane therapy. You all know that the taxanes are a mainstay of our treatment in the adjuvant, neoadjuvant, and metastatic breast cancer settings. The potential to have an oral formulation would be powerful for our patients, with more convenient administration, less time at an infusion center, and the potential that many patients may not need a port-a-cath or other access device. This is a wonderful option that I expect we will have soon.

The CONTESSA trial was the initial registration trial for the oral taxane tesetaxel. As a registration trial, it was designed to meet the regulatory needs of the US Food and Drug Administration (FDA). The study randomly assigned patients with metastatic disease to receive capecitabine alone or capecitabine with the addition of tesetaxel. It more than met its primary endpoint, progression-free survival. There were no unusual toxicities. I believe we can assume that this trial will result in the approval of this agent by the FDA once they've had time to delve into the details of the data and take that important careful review.

As with many registration trials, this doesn't tell us how this agent is most optimally used. Many of you who know my view of the data know that I cannot support combination chemotherapy for the majority of our patients. But this is a start. Once the agent is approved, we'll all be able to gain experience with it. Many other studies, including important trials evaluating tesetaxel monotherapy, will be coming soon.

This is not a new drug. We know how to use the taxanes and we know where they're helpful. But this gives us the option to think about oral therapy. Any time I have more options for patients to individualize treatment decisions, both in terms of what specific agents they need and how those agents can be administered to best meet their needs, that's a great day for my patients.

I hope you all are having a great day as well. I'll be back with you again soon.

Kathy D. Miller, MD, is associate director of clinical research and co-director of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University. Her career has combined both laboratory and clinical research in breast cancer.

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