{"entity":{"id":"destiny-pantumor02","kind":"trial","name":"DESTINY-PanTumor02","aka":[],"tldr":"DESTINY-PanTumor02 gave the HER2-directed antibody-drug conjugate Enhertu to 267 patients in seven cohorts of HER2-expressing solid tumours, endometrial and cervical cancer among them. Endometrial cancer responded best, and in April 2024 the FDA granted the first tumour-agnostic HER2 approval, for tumours with the strongest HER2 staining and no satisfactory alternative.","summary":"DESTINY-PanTumor02, trial NCT04482309 sponsored by AstraZeneca and Daiichi Sankyo and published in JCO in 2024, showed that trastuzumab deruxtecan shrinks tumours across seven cohorts of HER2-expressing cancers, with endometrial cancer among the best responders, leading to the first tumour-agnostic HER2 approval. It was a phase 2 of 267 patients with HER2 IHC 2+ or 3+ solid tumours in seven cohorts; the endometrial cohort responded in 57.5 percent overall and 84.6 percent of IHC 3+ cases, the cervical cohort in half, and FDA accelerated approval followed in April 2024 for HER2 IHC 3+ solid tumours with no satisfactory alternative. HER2 testing is now recommended in serous endometrial carcinoma, and how far the tumour-agnostic label should reach is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04482309","url":"https://clinicaltrials.gov/study/NCT04482309"},{"label":"JCO 2024","url":"https://ascopubs.org/doi/10.1200/JCO.23.02005"},{"label":"Enhertu label (openFDA): DESTINY-PanTumor02 efficacy by tumour type","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ENHERTU%22"}],"tags":[],"related":[],"cancers":["endometrial","cervical","endometrial-p53-abnormal","uterine-carcinosarcoma","recurrent-metastatic-cervical-cancer","gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["her2"],"drugs":["trastuzumab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":["tumour-agnostic"],"trials":[],"people":["funda-meric-bernstam"],"bottlenecks":[],"keyPapers":["paper-oh-destiny-pantumor02-biliary-pancreatic-esmo-open-2026"],"journals":[],"dependsOn":[],"notes":["Biliary tract cancer cohort: the tumour-agnostic FDA approval of April 2024 (HER2 IHC 3+ solid tumours with no satisfactory alternative) rests on this trial, and the Enhertu label table gives the biliary tract cohort with IHC 3+ as 22 patients with a confirmed response rate of 45.5 percent (95 percent confidence interval 24.4 to 67.8). Across the whole trial the IHC 3+ response rate was 51.4 percent (111 patients) with median duration of response 19.4 months. UK sites: London, Manchester and Sutton (registry). No NICE appraisal of trastuzumab deruxtecan for HER2-positive solid tumours or biliary tract cancer was found in September 2026."],"nct":"NCT04482309","phase":"2","setting":"HER2-expressing (IHC 2+/3+) solid tumours after ≥1 line, seven cohorts including endometrial and cervical: trastuzumab deruxtecan","sponsor":"AstraZeneca / Daiichi Sankyo","result":"Endometrial ORR 57.5% (84.6% in IHC 3+); cervical ORR 50%.","started":"2020-08-18","startedType":"actual","yearReported":2023,"enrolled":267,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, endometrial cohort","primary":true,"unit":"%","arms":[{"name":"T-DXd (all HER2 IHC 2+/3+)","n":40,"value":57.5},{"name":"T-DXd (IHC 3+ only)","n":13,"value":84.6}],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02005"},{"endpoint":"Objective response rate, cervical cohort","unit":"%","arms":[{"name":"T-DXd (all)","n":40,"value":50}],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02005"},{"endpoint":"Confirmed objective response by independent central review, biliary tract cancer cohort with HER2 IHC 3+ (Enhertu label)","unit":"%","arms":[{"name":"Trastuzumab deruxtecan (biliary tract, IHC 3+)","n":22,"value":45.5,"note":"95% CI 24.4 to 67.8; duration of response range 2.1 to 22.0 months"}],"source":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ENHERTU%22"}]},"route":"/trials/destiny-pantumor02/","neighbours":{"cancer":[{"id":"advanced-recurrent-endometrial-cancer","kind":"cancer","name":"Advanced or recurrent endometrial cancer","route":"/cancers/advanced-recurrent-endometrial-cancer/"},{"id":"biliary-tract-cancer","kind":"cancer","name":"Biliary tract cancer (all types)","route":"/cancers/biliary-tract-cancer/"},{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"endometrial-p53-abnormal","kind":"cancer","name":"p53-abnormal endometrial cancer, including uterine serous carcinoma","route":"/cancers/endometrial-p53-abnormal/"},{"id":"recurrent-metastatic-cervical-cancer","kind":"cancer","name":"Recurrent or metastatic cervical cancer","route":"/cancers/recurrent-metastatic-cervical-cancer/"},{"id":"uterine-carcinosarcoma","kind":"cancer","name":"Uterine carcinosarcoma","route":"/cancers/uterine-carcinosarcoma/"}],"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":"gallbladder-cancer-in-biliary-trials","kind":"term","name":"Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)","route":"/terms/gallbladder-cancer-in-biliary-trials/"},{"id":"tumour-agnostic","kind":"term","name":"Tumour-agnostic (tissue-agnostic) approval","route":"/terms/tumour-agnostic/"}],"person":[{"id":"funda-meric-bernstam","kind":"person","name":"Funda Meric-Bernstam","route":"/people/funda-meric-bernstam/"}],"paper":[{"id":"paper-destiny-pantumor02-jco-2024","kind":"paper","name":"DESTINY-PanTumor02: trastuzumab deruxtecan in HER2-expressing solid tumours","route":"/key-papers/paper-destiny-pantumor02-jco-2024/"},{"id":"paper-oh-destiny-pantumor02-biliary-pancreatic-esmo-open-2026","kind":"paper","name":"Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing biliary tract or pancreatic tumors: a subgroup analysis of DESTINY-PanTumor02","route":"/key-papers/paper-oh-destiny-pantumor02-biliary-pancreatic-esmo-open-2026/"}],"idea":[{"id":"idea-her2-adc-serous-endometrial","kind":"idea","name":"HER2 ADCs as standard for HER2-positive serous endometrial cancer","route":"/ideas/idea-her2-adc-serous-endometrial/"},{"id":"idea-gbc-reflex-her2-testing-advanced-biliary","kind":"idea","name":"Reflex HER2 testing of every advanced gallbladder and extrahepatic biliary cancer","route":"/ideas/idea-gbc-reflex-her2-testing-advanced-biliary/"}],"roadmap":[{"id":"gallbladder-cancer-roadmap","kind":"roadmap","name":"Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials","route":"/roadmaps/gallbladder-cancer-roadmap/"}]}}