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 MORE about the FDA 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
Tukysa Plus Herceptin May Offer ‘Chemotherapy-Free’ Regimen for HER2-Positive Colon Cancer (Cure Today)
Seagen touts new Tukysa colorectal cancer data, setting up FDA filing and a potential $500M opportunity (Fierce Pharma)
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 Plus Trastuzumab Yields Clinically Meaningful Antitumor Activity in HER2-Positive Metastatic Colorectal Cancer (Oncology Learning Network)
Tucatinib/Trastuzumab Combo Elicits Tumor Response in HER2+ mCRC (Oncology Nursing News)
Pivotal Trial Demonstrates Antitumor Activity With Tucatinib, Trastuzumab in Previously Treated HER2-Positive Metastatic Colorectal Cancer (Pharmacy Times)
Tucatinib Plus Trastuzumab Provides Durable Responses in Patients With HER2-Positive mCRC (Targeted Oncology)
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."