FDA Approval Insights: First-Line Maintenance Tucatinib/Trastuzumab/Pertuzumab in Advanced HER2+ Breast Cancer

In today’s episode, we spoke with Erika P. Hamilton, MD, about the FDA approval of tucatinib (Tukysa) plus trastuzumab (Herceptin) and pertuzumab (Perjeta) for the maintenance treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer following induction therapy. Dr Hamilton is director of Breast Cancer and Gynecologic Cancer Research at Sarah Cannon Research Institute.

This regulatory decision was backed by data from the phase 3 HER2CLIMB-05 trial (NCT05132582), in which treatment with tucatinib plus trastuzumab and pertuzumab generated a median progression-free survival of 24.9 months (95% CI, 21.3-not reached) vs 16.3 months (95% CI, 12.6-18.7) with placebo, translating to a 35.9% reduction in the risk of disease progression or death (HR, 0.64; 95% CI, 0.51-0.80; 2-sided P < .0001).

In our exclusive interview, Dr Hamilton highlighted the significance of this approval, key data from HER2CLIMB-05, and potential next steps for the HER2-positive breast cancer treatment paradigm.