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

Image Caption
5-year metastatic colorectal cancer survivor, Elle Charnisky (photo taken at Duke Cancer Center in summer 2021 by Julie Poucher Harbin)
John Strickler at a Molecular Tumor Board meeting
John Strickler, MD, addresses a Molecular Tumor Board meeting in 2019

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.

The idea to test these drugs in HER2-positive colorectal cancer patients was initiated by DCI GI oncologist and co-leader of DCI's Precision Cancer Medicine and Investigational Therapeutics Research Program, John Strickler, MD, who first reached out to Seagen (then Cascadian Therapeutics and the maker of tucatinib) around 2015.
Elle Charnisky and her care team (photo by Drawbridge Media)
Elle Charnisky and her care team on April 14, 2022 (photo by Drawbridge Media)
On August 8, 2017, the first patient nationwide to be accrued — Elle Charnisky — began the trial at DCI. Now a 5-year metastatic colorectal cancer survivor, Charnisky is still going strong and most recently shared her story at the DCI 50th Anniversary celebration held on April 14.

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."

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