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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

TUKYSA® (tucatinib) in Combination with Antibody-Drug Conjugate ado-Trastuzumab Emtansine Improves Progression-Free Survival in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer

Published date:
12/06/2023
Excerpt:
Seagen Inc. (Nasdaq: SGEN) today announced data from the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®). The combination showed a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint, in patients with unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer who had been previously treated with trastuzumab and a taxane, compared to those who received placebo plus ado-trastuzumab emtansine.
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Seagen Phase 3 Trial of TUKYSA® (tucatinib) in Combination with Antibody-Drug Conjugate ado-trastuzumab emtansine Meets Primary Endpoint of Progression-Free Survival in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer

Published date:
08/16/2023
Excerpt:
Seagen Inc. (Nasdaq: SGEN) today announced that the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®) met its primary endpoint of progression-free survival (PFS). Patients in the trial had unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer and had received previous treatment with a taxane and trastuzumab.​
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

Excerpt:
...- HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines....
Trial ID:
Evidence Level:
Sensitive: D – Preclinical
Title:

HER2-selective and reversible tyrosine kinase inhibitor tucatinib potentiates the activity of T-DM1 in preclinical models of HER2-positive breast cancer

Published date:
09/11/2023
Excerpt:
We characterized the activity of tucatinib with the antibody-drug conjugate T-DM1 in preclinical models of breast cancer, including HER2-positive breast cancer cells and patient-derived xenograft (PDX) models….In combination, tucatinib and T-DM1 showed an enhanced, often synergistic, cytotoxic response and demonstrated improved antitumor activity in vivo, including in PDX models refractory to T-DM1 single agent activity....These results suggest that tucatinib may be the optimal TKI partner for HER2-targeted therapies and support clinical studies of its combination with T-DM1, including in patients with brain metastases.
DOI:
https://doi.org/10.1158/2767-9764.CRC-23-0302