Seagen: TUKYSA trial in combo with Kadcyla meets primary endpoint of PFS

Seagen 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.? Overall survival OS data, a secondary endpoint, are not yet mature. Discontinuations due to adverse events were more common in the combination arm of the trial, but no new safety signals emerged for the combination. “We are encouraged by these results for TUKYSA in combination with Kadcyla in metastatic HER2-positive breast cancer, including in patients with brain metastases,” said Roger Dansey, President of Research and Development and Chief Medical Officer at Seagen. “We plan to present the HER2CLIMB-02 data at an upcoming medical meeting and discuss the results with the FDA.”