{"entity":{"id":"destiny-crc02","kind":"trial","name":"DESTINY-CRC02","aka":[],"tldr":"Enhertu shrank about four in ten heavily pretreated HER2-positive bowel cancers, including ones that had already stopped responding to other HER2 drugs.","summary":"DESTINY-CRC02, trial NCT04744831 sponsored by Daiichi Sankyo and AstraZeneca and reported in 2023, showed that trastuzumab deruxtecan shrinks about four in ten heavily pretreated HER2-positive metastatic colorectal cancers, including ones that had already stopped responding to other HER2 drugs. It randomised 122 patients to 5.4 or 6.4 mg/kg, with confirmed response rates of 37.8 and 27.5 percent respectively, responses regardless of prior HER2 therapy or RAS status, and the data supported the 2024 tumour-agnostic HER2 IHC 3+ accelerated approval, which covers colorectal cancer at the lower dose. OnCo links it to colorectal cancer, HER2 as a target, trastuzumab deruxtecan and the tumour-agnostic approval term, and the result is consistent with DESTINY-CRC01. Without a randomised comparison, whether the drug improves survival over other HER2 combinations is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04744831","url":"https://clinicaltrials.gov/study/NCT04744831"}],"tags":[],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["her2"],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["tumour-agnostic"],"trials":["destiny-crc01","mountaineer-03"],"people":[],"bottlenecks":[],"keyPapers":["paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015","paper-destiny-crc02-lancet-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04744831","phase":"2","setting":"Pretreated HER2-positive metastatic colorectal cancer: T-DXd 5.4 vs 6.4 mg/kg","sponsor":"Daiichi Sankyo / AstraZeneca","result":"ORR 37.8% (5.4 mg/kg).","started":"2021-03-05","startedType":"actual","yearReported":2023,"enrolled":122,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"percent","arms":[{"name":"T-DXd 5.4 mg/kg","n":82,"value":37.8},{"name":"T-DXd 6.4 mg/kg","n":40,"value":27.5}],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00380-2/abstract"}],"replication":"Consistent with DESTINY-CRC01 (ORR 45% in IHC3+/ISH+)."},"route":"/trials/destiny-crc02/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"her2-amplified-colorectal","kind":"cancer","name":"HER2-amplified colorectal cancer","route":"/cancers/her2-amplified-colorectal/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"drug":[{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"},{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}],"term":[{"id":"tumour-agnostic","kind":"term","name":"Tumour-agnostic (tissue-agnostic) approval","route":"/terms/tumour-agnostic/"}],"trial":[{"id":"destiny-crc01","kind":"trial","name":"DESTINY-CRC01","route":"/trials/destiny-crc01/"},{"id":"mountaineer-03","kind":"trial","name":"MOUNTAINEER-03","route":"/trials/mountaineer-03/"}],"paper":[{"id":"paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015","kind":"paper","name":"Assessment of a HER2 scoring system for colorectal cancer: results from a validation study","route":"/key-papers/paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015/"},{"id":"paper-siena-destiny-crc01-trastuzumab-deruxtecan-lancet-oncol-2021","kind":"paper","name":"Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01)","route":"/key-papers/paper-siena-destiny-crc01-trastuzumab-deruxtecan-lancet-oncol-2021/"},{"id":"paper-destiny-crc02-lancet-oncol-2024","kind":"paper","name":"Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): primary results from a multicentre, randomised, phase 2 trial","route":"/key-papers/paper-destiny-crc02-lancet-oncol-2024/"}]}}