Tukysa (tucatinib)

This trial has been approved by the Institutional Review Board (IRB) and began patient enrollment in January 2024. The trial will provide insights into the safety and effectiveness of a novel combinatorial therapy for BCBM.

Our model, based on NIH 3T3 cells, became sensitive to the monoclonal antibody trastuzumab and to the selective HER2 tyrosine kinase inhibitor tucatinib. The results suggest that this model could be a promising tool for preclinical functional cross-reactivity tests of anti-HER2 therapies before in vivo studies.

The addition of tucatinib to T-DM1 improved PFS in patients with previously treated HER2+ LA/MBC, including patients with BMs, and exhibited a manageable safety profile.

P=N/A, N=93, Completed, Pfizer | Active, not recruiting --> Completed

P=N/A, N=600, Not yet recruiting, Pfizer | Trial completion date: Jun 2030 --> May 2029 | Trial primary completion date: Jun 2030 --> May 2029

P1/2, N=81, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Sep 2029 --> Apr 2030 | Trial primary completion date: Sep 2029 --> Apr 2030

P3, N=1056, Active, not recruiting, Alliance for Clinical Trials in Oncology | Recruiting --> Active, not recruiting

P2, N=40, Active, not recruiting, Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Sep 2025 --> Dec 2025

Our results align with data presented from the HER2CLIMB trial. Considerably fewer patients than initially expected have been treated in Denmark.

P2, N=32, Active, not recruiting, University of Sydney | Recruiting --> Active, not recruiting

P3, N=654, Active, not recruiting, Seagen, a wholly owned subsidiary of Pfizer | Trial primary completion date: Feb 2026 --> Sep 2025

Although the 2LT pattern in Greece generally aligned with guidelines, persistently poor treatment outcomes underscore a significant unmet medical need for these patients.