{"entity":{"id":"paper-ohba-herb-trastuzumab-deruxtecan-biliary-jco-2024","kind":"paper","name":"Trastuzumab deruxtecan in human epidermal growth factor receptor 2-expressing biliary tract cancer (HERB; NCCH1805): a multicenter, single-arm, phase II trial","aka":[],"tldr":"The antibody-drug conjugate trastuzumab deruxtecan shrank tumours in about a third of Japanese patients with HER2-positive bile duct or gallbladder cancer after chemotherapy, and in one in eight with low HER2, but a quarter developed lung inflammation and two died of it.","summary":"Patients from five Japanese institutions with pathologically confirmed unresectable or recurrent biliary tract cancer, centrally confirmed HER2-positive (IHC 3+, or IHC 2+ and ISH-positive) or HER2-low (IHC 2+ and ISH-negative, IHC 1+, or IHC 0 and ISH-positive), refractory or intolerant to a gemcitabine-containing regimen, received trastuzumab deruxtecan 5.4 mg/kg every 3 weeks. The primary endpoint was confirmed objective response rate in HER2-positive disease by independent central review (threshold 15%, expected 40%).\n\n32 patients were enrolled and treated. The 22 with HER2-positive disease had a confirmed objective response rate of 36.4% (90% CI 19.6 to 56.1; P = 0.01), meeting the primary endpoint; the 8 with HER2-low disease had a confirmed response rate of 12.5%. The most common grade 3 or worse treatment-related adverse events were anaemia (53.1%) and neutropenia (31.3%). Eight patients (25.0%) had interstitial lung disease, including two grade 5 events.","asOf":"2026-09-24","links":[{"label":"Ohba et al., J Clin Oncol 2024: trastuzumab deruxtecan in HER2-expressing biliary tract cancer (HERB)","url":"https://doi.org/10.1200/jco.23.02010"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/39102634/"}],"tags":[],"related":[],"cancers":["gallbladder","biliary-tract-cancer","cholangiocarcinoma"],"sections":[],"technologies":[],"targets":["her2"],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":["ncc-japan"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["jco"],"dependsOn":[],"notes":[],"journal":"Journal of Clinical Oncology","year":2024,"doi":"10.1200/jco.23.02010","pmid":"39102634","authors":"Ohba A, Morizane C, Kawamoto Y, et al.","paperType":"observational","findings":["Confirmed objective response rate 36.4% (8 of 22) in HER2-positive and 12.5% (1 of 8) in HER2-low biliary tract cancer.","Grade 3 or worse anaemia 53.1% and neutropenia 31.3%.","Interstitial lung disease in 25.0% (8 of 32), two fatal."],"whatItMeans":"Together with the DESTINY-PanTumor02 biliary cohort this is the evidence behind trastuzumab deruxtecan's tumour-agnostic IHC 3+ label being used in gallbladder cancer; the lung toxicity rate, higher than in breast cancer, is the caution for a population with pre-existing lung and liver compromise.","caveats":["32 patients, single arm, Japanese centres only.","Two treatment-related deaths from interstitial lung disease in a small cohort."],"changedPractice":false,"participants":32},"route":"/key-papers/paper-ohba-herb-trastuzumab-deruxtecan-biliary-jco-2024/","neighbours":{"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":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"}],"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/"}],"institution":[{"id":"ncc-japan","kind":"institution","name":"National Cancer Center Hospital","route":"/institutions/ncc-japan/"}],"journal":[{"id":"jco","kind":"journal","name":"Journal of Clinical Oncology","route":"/journals/jco/"}]}}