Pfizer's Tukysa Combo Shows Strong PFS Benefit In Metastatic Breast Cancer

Pfizer Inc. (NYSE:PFE) on Wednesday shared detailed results from the Phase 3 HER2CLIMB-05 trial of Tukysa (tucatinib) as part of an investigational first-line maintenance treatment combination, following chemotherapy-based induction.

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The trial included patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).

The primary endpoint analysis showed a 35.9% reduction in the risk of disease progression or death among patients treated with Tukysa, trastuzumab and pertuzumab compared to those treated with placebo, trastuzumab and pertuzumab.

These findings were published in the “Journal of Clinical Oncology,” shared at the San Antonio Breast Cancer Symposium.

In HER2CLIMB-05, the median progression-free survival (PFS) was 24.9 months in the Tukysa arm and 16.3 months in the placebo arm, representing an extension in median PFS of 8.6 months.

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A PFS benefit was observed across all prespecified patient subgroups.

The key secondary endpoint of overall survival was not mature at the time of the analysis but showed a numerical trend for improvement with Tukysa.

Tukysa, in combination with trastuzumab and pertuzumab, demonstrated a safety profile generally consistent with the established safety profiles of each therapy, except for a higher rate of asymptomatic Grade ≥3 liver transaminases, which were typically manageable and reversible with Tukysa dose modifications and/or discontinuations.

PFE Price Action: Pfizer stock is up 0.93% at $25.57 at publication on Wednesday.

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