Seattle Genetics Announces Positive Topline Results From HER2CLIMB Trial

(RTTNews) - Seattle Genetics, Inc. (SGEN) said the double-blind HER2CLIMB trial evaluating tucatinib in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer met the primary endpoint of progression-free survival. The trial also met the two key secondary endpoints at interim analysis. Tucatinib in combination with trastuzumab and capecitabine was generally well tolerated with a manageable safety profile.

Roger Dansey, Chief Medical Officer at Seattle Genetics, said: "Based on these findings, we plan to unblind the trial and offer tucatinib to patients on the control arm. We also plan to submit a New Drug Application to the FDA in the first quarter of 2020, with the goal of bringing a much-needed new medicine to patients."