Pfizer's TUKYSA Boosts Survival in HER2+ Breast Cancer Trial

Pfizer has disclosed positive Phase 3 results from the HER2CLIMB-05 trial, which is an important advancement for patients with HER2-positive (HER2+) metastatic breast cancer (MBC).

In this study, TUKYSA (tucatinib) was assessed in combination with trastuzumab and pertuzumab as a first-line maintenance therapy and achieved a statistically significant and clinically meaningful improvement in progress-free survival (PFS) as compared with placebo.

All treatment arms received standard maintenance therapy of trastuzumab plus pertuzumab after induction chemotherapy.

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According to Dr. Erika Hamilton, Principal Investigator of HER2CLIMB-05 and Director of Breast Cancer Research at the Sarah Cannon Research Institute, the findings suggest that adding TUKYSA to standard maintenance therapy can delay disease progression, offering patients a well-tolerated, chemotherapy-free approach. The safety profile of TUKYSA was consistent with previously known data for the individual agents.

HER2+ breast cancer accounts for about 15–20% of all breast cancers and is often linked to poor prognosis, with five-year survival rates for metastatic cases ranging between 41–47%. Despite therapeutic advances, the standard first-line maintenance treatment has remained unchanged since 2012, and most patients see progression within two years.

Dr. Johanna Bendell, Chief Development Officer of Oncology at Pfizer, emphasized that these results position TUKYSA as a potential game-changer in redefining maintenance therapy for HER2+ MBC, reinforcing Pfizer’s commitment to advancing front-line cancer care.