Pfizer Inc. (NYSE:PFE) on Tuesday announced the initial results from a clinical trial called HER2CLIMB-05.  

This trial tested a new treatment for patients with a type of breast cancer (metastatic breast cancer (MBC)) that is positive for HER2, which means the cancer cells have a specific protein that helps them grow.

The treatment combines a drug called Tukysa (tucatinib), which is a type of medicine that targets cancer cells, with other therapies. The trial is in its third phase, which means it’s a large study to see how well this combination works for patients with advanced breast cancer.

HER2CLIMB-05 is evaluating Tukysa versus placebo, both in combination with first-line standard-of-care maintenance therapy (trastuzumab plus pertuzumab) following chemotherapy-based induction.

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Data

The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in the Tukysa arm versus the placebo arm.

Treatment with TUKYSA in combination with trastuzumab and pertuzumab was tolerable, with a safety profile generally consistent with the established safety profiles of each therapy.

Results from HER2CLIMB-05 will be presented at a future medical congress and discussed with regulatory authorities.

Since its initial approval in 2020, Tukysa has become a standard of care for HER2+ MBC patients in the third-line setting and has been approved in more than 50 countries.

In the United States, Tukysa is approved by the U.S. Food and Drug Administration for use in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2+ breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

Tukysa is not currently approved for first-line treatment.

Price Action: Pfizer shares were down 0.26% at $24.66 at the time of publication on Tuesday, according to Benzinga Pro data.

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