Benzinga | Sep 28, 2021 08:05AM EDT

Seagen Reports Last Patient Enrolled In Phase 2 MOUNTAINEER Trial Evaluating TUKYSA Regimen In HER2-Positive Metastatic Colorectal Cancer

Seagen Inc. (NASDAQ:SGEN) today announced it completed patient enrollment in the phase 2 open-label MOUNTAINEER clinical trial, evaluating TUKYSA(r) (tucatinib) in combination with trastuzumab (Herceptin(r)) and as a single agent in patients with HER2-positive (HER2+) metastatic colorectal cancer (mCRC) following previous treatment with first- and second-line standard-of-care therapies.

"Completing enrollment in the MOUNTAINEER trial is an important step toward potentially bringing this therapy to patients with HER2-positive metastatic colorectal cancer," said Roger D. Dansey, M.D., Chief Medical Officer, Seagen. "We previously expanded the size of this trial, with the intention of supporting registration under accelerated approval regulations in the United States. We look forward to receiving the trial results to potentially address a significant unmet medical need for patients."

Early results from the MOUNTAINEER trial were presented at the European Society for Medical Oncology (ESMO) 2019 Congress and showed encouraging anti-tumor activity with a well-tolerated safety profile.1

TUKYSA is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2. HER2 amplification or overexpression occurs in approximately three-to-five percent of all patients with mCRC.2,3