MOUNTAINEER & MOUNTAINEER-03
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). MOUNTAINEER-03 (NCT05253651, ~400 patients) randomises first-line tucatinib + trastuzumab + mFOLFOX6 vs mFOLFOX6 ± bevacizumab or cetuximab; enrolling.
- 38.1 out of 100 people had their tumour shrink with Tucatinib + trastuzumab.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: HER2-positive RAS wild-type metastatic colorectal cancer: tucatinib + trastuzumab (phase 2, pretreated); tucatinib + trastuzumab + mFOLFOX6 vs standard first line (phase 3). People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
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.
Pages like this
not linked directly; found by shared links- TrialHER2CLIMB-05
Shares Tucatinib, Trastuzumab.
- PairingTucatinib + trastuzumab + capecitabine for brain metastases
Shares Tucatinib, Trastuzumab.
- InstitutionInstituto Alexander Fleming
Shares Trastuzumab, HER2, Colorectal cancer.
- PersonNancy U. Lin
- PersonPaulo Hoff
Shares FOLFOX (5-FU, leucovorin, oxaliplatin), Colorectal cancer.
- InstitutionMayo Clinic Comprehensive Cancer Center – Arizona
Shares Tanios Bekaii-Saab, Colorectal cancer.
- TrialDESTINY-CRC02
Shares HER2, Colorectal cancer.
- TrialHER2CLIMB
Shares Tucatinib, Trastuzumab, HER2.