First Patient Dosed in Phase 3 Trial of Tucatinib-Kadcyla Combo for Advanced HER2-Positive Breast Cancer

First Patient Dosed in Phase 3 Trial of Tucatinib-Kadcyla Combo for Advanced HER2-Positive Breast Cancer
A Phase 3 trial exploring a combination of Seattle Genetics' tucatinib plus standard Kadcyla (ado-trastuzumab emtansine) in people with advanced HER2-positive breast cancer has dosed its first participant, the company announced. The trial — called HER2CLIMB-02 (NCT03975647) — is enrolling up to 460 adult patients with metastatic or inoperable, locally advanced disease who received prior treatment with a taxane chemotherapy and trastuzumab. The trial's results are expected to be included in Seattle Genetics' application seeking approval for tucatinib in the U.S. for this indication. “We are building a comprehensive strategy for tucatinib in combination with other medicines across a range of HER2-positive cancers,” Roger Dansey, MD, chief medical officer at Seattle Genetics, said in a news release. “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,” he said. “This trial has the potential to support tucatinib use in earlier lines of therapy.” When breast cancers are driven by the protein HER2, which acts to send signals that drive excessive cell growth and is associated with more aggressive cancers, the standard approach is targeted therapy against this protein. Many HER2-targeted treatments exist for breast cancer patients, including trastuzumab and Perjeta (pertuzumab) — antibodies that target and inhibit HER2 — and Kadcyla (ado-trastuzumab emtansine), which is trastuzumab bound to a toxic payload. However, patients may still see their disease progress after all these treatments. Tucatinib is an oral investigational small molecule inhibitor of the HER2 receptor with the ability to cross the blood-bra
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