The approval comes after a clinical trial update that involved Breast Cancer Research Foundation investigators.
Key Takeaways
- The FDA has approved adding tucatinib, an oral tyrosine kinase inhibitor, to trastuzumab and pertuzumab for maintenance treatment for patients with HER2-positive metastatic breast cancer.
- Results from the HER2CLIMB-05 trial, led by BCRF researcher Nancy U. Lin, showed that adding tucatinib reduced the risk of disease progression or death by 36%.
- Patients who received tucatinib along with trastuzumab and pertuzumab had a median progression-free survival of 24.9 months, compared with 16.3 months for those who received a placebo along with trastuzumab and pertuzumab.
The U.S. Food & Drug Administration (FDA) recently approved a first-line maintenance treatment combination for patients with metastatic or locally advanced HER2-positive metastatic or locally advanced breast cancer. The maintenance treatment includes the use of tucatinib (Tukysa®) in combination with trastuzumab and pertuzumab.
Treatment approval was based on results from the HER2CLIMB-05 trial, which looked into whether adding tucatinib to the standard maintenance regimen of trastuzumab and pertuzumab could improve progression-free survival (PFS) among patients with HER2-positive metastatic breast cancer. BCRF researcher Dr. Nancy U. Lin was a lead investigator on the trial.
Results found that adding tucatinib to the maintenance treatment regimen reduced the risk of disease progression or death by 36%. Patients treated with tucatinib had a median of 24.9 months of progression-free survival, as opposed to 16.3 months among those given the placebo.
Trastuzumab (Herceptin®) and pertuzumab (Perjeta®), monoclonal antibodies, are used together as an initial maintenance treatment for patients with this type of breast cancer. Administered through infusion or injection, they specifically target cancer cells that express the HER2 protein. Together with tucatinib, an oral tyrosine kinase inhibitor, this combination offers an effective first-line maintenance treatment for those with HER2-positive breast cancer to help stop disease progression.
While more research is needed, and overall survival data needs more time, these findings show progress in delaying disease progression for people with HER2-positive metastatic breast cancer.
The Breast Cancer Research Foundation is the largest private funder of metastatic breast cancer research in the world. Right now, there are an estimated 170,000 people living with metastatic breast cancer in the United States. Donate today to fuel the research helping to find an end to breast cancer.
