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A HER2 pill with an antibody gave a 38 percent response rate in chemotherapy-refractory HER2-positive bowel cancer, and became the first HER2-directed regimen approved for the disease.
Strickler, Cercek, Siena and colleagues enrolled patients aged 18 and older with chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer at 34 sites in Belgium, France, Italy, Spain and the United States. The study began as a single cohort of tucatinib 300 mg orally twice daily plus intravenous trastuzumab, and after an interim analysis expanded with randomisation 4:3 to the combination or to tucatinib alone. The primary endpoint was confirmed objective response by blinded independent central review in the two combination cohorts together.
Between August 2017 and September 2021, 117 patients were enrolled; 114 had locally assessed HER2-positive disease and received treatment, with a median age of 56.
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.
The antibody-drug conjugate route into HER2-positive colorectal cancer, extended by DESTINY-CRC02 at a lower dose; interstitial lung disease is the class risk that defines how the drug is monitored.
The first demonstration that HER2 is actionable in colorectal cancer, and the trial that defined the colorectal-specific HER2 scoring criteria every later trial has used.
Shares Thierry André, Eric Van Cutsem, 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, Merck & Co. (MSD) and the tag colorectal-evidence.
Shares Eric Van Cutsem, Pfizer (incl. Seagen), 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, Monoclonal antibodies and the tag colorectal-evidence.
Shares Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES), 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, HER2 and the tag colorectal-evidence.
Shares Thierry André, Eric Van Cutsem, 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, Colorectal cancer and the tag colorectal-evidence.
Shares Eric Van Cutsem, 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, Small-molecule kinase inhibitors, Colorectal cancer and the tag colorectal-evidence.
Shares Salvatore Siena, 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, Monoclonal antibodies, Colorectal cancer and the tag colorectal-evidence.
Shares Eric Van Cutsem, 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, Small-molecule kinase inhibitors, Colorectal cancer and the tag colorectal-evidence.
Shares Andrea Cercek, 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, Colorectal cancer and the tag colorectal-evidence.