MOUNTAINEER: A Homegrown Story of Survival and Promise
(UPDATE 1.19.23) Regimen Approved Based on MOUNTAINEER Results
John Strickler, MD, and team's milestone work on the clinical trial "MOUNTAINEER" has led to the first FDA-approved treatment regimen for patients with HER2+ metastatic colorectal cancer. Tucatinib (Tukysa, Seagen Inc.), in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, was granted accelerated approval.
READ about the history behind the ground-breaking trial and the trial's first participant, below
(UPDATE 7.27.22) Coverage of MOUNTAINEER results presentation at ESMO
Dr. Strickler on the Rationale of Examining Tucatinib with Trastuzumab in HER2+ CRC AND Tucatinib Plus Trastuzumab Induces Durable Tumor Response in HER2+ mCRC AND Dr. Strickler on the Efficacy of Tucatinib/ Trastuzumab in HER2+ Colorectal Cancer (OncLive)
Tucatinib/Trastuzumab Combo Elicits Tumor Response in HER2+ mCRC (Oncology Nursing News)
Seagen releases data from Tukysa pivotal trial in HER2+ mCRC (The Pharma Letter)
Global biotech company Seagen Inc. announced positive topline results last month of a pivotal phase 2 clinical trial (called MOUNTAINEER) of tucatinib in combination with trastuzumab in HER2-positive metastatic colorectal cancer. Both drugs are used in breast cancer, a type of cancer where HER2 amplification is common. HER2 amplification is uncommon, however, in colorectal cancer.
Strickler will present the full data at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona, Spain — to be held June 29 through July 2, 2022. According to Seagen, "data from this trial will form the basis of a planned supplemental New Drug Application to the FDA under the FDA’s Accelerated Approval Program."