Overview
- Topline HER2CLIMB-05 results show a statistically significant, clinically meaningful progression-free survival benefit for tucatinib added to trastuzumab and pertuzumab versus placebo.
- Investigators reported the regimen was tolerable with a safety profile consistent with the known effects of each therapy.
- The randomized, double-blind, placebo-controlled study enrolled patients without progression after 4–8 cycles of induction therapy with trastuzumab, pertuzumab, and a taxane.
- Full efficacy and safety details remain pending public presentation, with Pfizer preparing to discuss the results with regulators for potential expanded use.
- Tukysa is currently approved in later-line HER2-positive metastatic breast cancer; success in this setting could mark the first maintenance regimen update in over a decade and support a shift toward chemotherapy-sparing care.