Seattle Genetics has Phase 1b breast cancer data

Seattle Genetics announced that results of a phase 1b clinical trial of tucatinib in combination with standard of care agents for the treatment of patients with advanced HER2-positive metastatic breast cancer were recently published in the journal The Lancet Oncology. Results demonstrated that tucatinib in combination with trastuzumab and capecitabine was generally well-tolerated and had encouraging clinical activity in heavily pre-treated patients with advanced HER2+ breast cancer, including those with brain metastases. A separate phase 1b clinical trial of tucatinib in combination with ado-trastuzumab emtansine was published in JAMA Oncology. Results showed an acceptable safety profile and preliminary antitumor activity among heavily pretreated patients with HER2+ metastatic breast cancer, with and without brain metastases. Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2. The first trial was a phase 1b triplet study was an open-label dose-escalation and expansion cohort study of tucatinib in combination with capecitabine and/or trastuzumab in patients with HER2+ metastatic breast cancer, including those with or without brain metastases. The objective of the study was to assess the safety, tolerability, pharmacokinetics and antitumor activity, and to determine the recommended phase 2 dose of tucatinib in combination with these agents. Once a recommended phase 2 dose of 300 mg BID was established in the triplet combination, an expansion cohort using that regimen was opened. The trial enrolled 60 patients with HER2+ metastatic breast cancer who had previously received a median of three HER2-targeted agents, such as trastuzumab, pertuzumab, lapatinib or T-DM1. The second trial was a phase 1b, open-label dose escalation and expansion cohort study of tucatinib in combination with T-DM1 enrolled 57 patients with HER2+ breast cancer. The objective of the study was to assess the safety, tolerability, pharmacokinetics and antitumor activity, and to determine the recommended phase 2 dose of tucatinib in combination with T-DM1. Participants in the study previously received a median of two prior HER2-directed therapies.

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