Seattle Genetics Starts Phase 3 for Breast Cancer Combo

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced dosing of the first patient in HER2CLIMB-02, a randomized phase 3 clinical trial evaluating investigational agent tucatinib versus placebo, in combination with standard-of-care ado-trastuzumab emtansine (T-DM1, Kadcyla^®), for patients with locally advanced or metastatic HER2-positive (HER2+) breast cancer. This trial is intended to support registration in the U.S. Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2.

“We are building a comprehensive strategy for tucatinib in combination with other medicines across a range of HER2-positive cancers,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “We are pleased to advance this tucatinib clinical trial with the vision of improving combination outcomes for patients with HER2-positive metastatic breast cancer who receive T-DM1. This trial has the potential to support tucatinib use in earlier lines of therapy.”
HER2CLIMB-02 is a multi-center, randomized, double-blind, placebo-controlled phase 3 trial designed to evaluate tucatinib versus placebo, in combination with T-DM1, in patients with unresectable locally-advanced or metastatic HER2+ breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab in any setting. The primary endpoint is progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints include overall survival, objective response rate and duration of response. The trial is expected to enroll approximately 460 patients. More information about this phase 3 trial, including enrolling centers, is available at www.clinicaltrials.gov.
https://www.biospace.com/article/releases/seattle-genetics-announces-initiation-of-phase-3-clinical-trial-of-tucatinib-in-combination-with-ado-trastuzumab-emtansine-t-dm1-kadcyla-for-patients-with-advanced-or-metastatic-her2-positive-breast-cancer/