Updated results from pivotal HER2CLIMB trial evaluating Tukysa in patients with HER2-positive breast cancer – Seagen Inc

Seagen Inc. announced the presentation of new data from exploratory analyses from the pivotal HER2CLIMB trial showing that improvement in overall survival (OS) was maintained after an additional 15.6 months of follow-up when Tukysa (tucatinib) was combined with trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer (MBC) who had stable or active brain metastases. The data were featured in a spotlight poster (Abstract #PD4-04) at the 2021 San Antonio Breast Cancer Symposium (SABCS).

“The risk of breast cancer spreading to the brain is more pronounced for patients with aggressive subtypes of breast cancer, including HER2-positive breast cancer,” said Nancy U. Lin, M.D., Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber in Boston, MA. “These analyses provide a hopeful outcome for patients with HER2-positive metastatic breast cancer when cancer has spread to the brain as they show that the Tukysa regimen not only helped patients live longer but also slowed disease progression in the brain.”

After a median follow-up of 29.6 months, the Tukysa regimen improved OS for patients with brain metastases by 9.1 months compared to trastuzumab and capecitabine alone (21.6 months vs. 12.5 months) (HR: 0.60; [95% CI: 0.44, 0.81]). The benefit extended to patients with active or stable brain metastases.

Tukysa treatment continued to show clinically meaningful benefit in progression-free survival in the central nervous system (CNS-PFS), representing a delay of cancer progression in the brain. The rates for intracranial objective response rate (ORR-IC) and duration of objective response (DOR-IC) were consistent with previous analyses..