India Pharma Outlook Team | Friday, 12 December 2025
Pfizer’s HER2-targeted therapy TUKYSA delivered a strong boost in first-line maintenance treatment for HER2-positive metastatic breast cancer, marking a major advance in today’s data from the Phase 3 HER2CLIMB-05 trial.
The study showed that adding TUKYSA, trastuzumab, and pertuzumab after initial chemotherapy cut the risk of disease progression or death by 35.9% compared with the current maintenance approach.
Findings were published in the Journal of Clinical Oncology and presented at the San Antonio Breast Cancer Symposium, giving the industry a closer look at how this regimen could reshape front-line care. Median progression-free survival reached 24.9 months with TUKYSA, up from 16.3 months on placebo, offering patients an 8.6-month gain without disease growth.
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The benefit held across patient groups, including those with brain metastases, a group often facing limited options. Early overall survival results also leaned in favor of TUKYSA, though the data is still maturing.
Erika Hamilton, principal investigator of HER2CLIMB-05, noted that, “Most patients with HER2-positive metastatic breast cancer face disease progression within two years of starting first-line treatment.” She added that these results show tucatinib can extend the time patients remain stable while keeping side effects manageable.
The safety profile aligned with known effects of the individual drugs, aside from higher but reversible Grade ≥3 liver enzyme elevations. Common reactions included diarrhea, liver events, and nausea.
Jeff Legos, Chief Oncology Officer at Pfizer, said TUKYSA has already become a trusted later-line treatment, and the new data supports its potential role in a chemotherapy-free, first-line maintenance strategy.
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