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A HER2 pill plus antibody gave durable responses in the 3-5% of bowel cancers driven by HER2, and is now being tested as first-line treatment.
MOUNTAINEER phase 2: confirmed ORR 38.1%, median duration of response 12.4 months; FDA accelerated approval January 2023 (first HER2-directed regimen in CRC). The randomised phase 3 successor is a separate record, MOUNTAINEER-03 (NCT05253651, 400 patients, primary completion December 2027).
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
A second publication from the MOUNTAINEER trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
The first United States approval of a HER2-directed regimen in colorectal cancer, and the basis for MOUNTAINEER-03, which is testing the combination with chemotherapy in the first line.
It fixes the population size for HER2-directed therapy, shows the enrichment in wild-type disease that makes reflex HER2 testing worthwhile there, and establishes that HER2 is not itself prognostic in this cancer.
It is the threshold behind the colorectal HER2 approvals: the more-than-50% rule, rather than the 10% used in gastric cancer, is what a pathologist applies when a bowel cancer is called HER2-positive.
Shares DESTINY-CRC01, MOUNTAINEER-03, Assessment of a HER2 scoring system for colorectal cancer: results from a validation study, HER2-amplified colorectal cancer.
Shares TRIUMPH, HER2 overexpression and amplification as a potential therapeutic target in colorectal cancer: analysis of 3256 patients enrolled in the QUASAR, FOCUS and PICCOLO colorectal cancer trials, Assessment of a HER2 scoring system for colorectal cancer: results from a validation study, HER2-amplified colorectal cancer.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, HER2-amplified colorectal cancer, Trastuzumab.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, Pfizer (incl. Seagen), Trastuzumab.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, Pfizer (incl. Seagen), Trastuzumab.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, Pfizer (incl. Seagen), Trastuzumab.
Shares Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER), HER2-amplified colorectal cancer, Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation, Trastuzumab.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, Pfizer (incl. Seagen), Trastuzumab.