# Trastuzumab deruxtecan in human epidermal growth factor receptor 2-expressing biliary tract cancer (HERB; NCCH1805): a multicenter, single-arm, phase II trial

Source: https://onco.cc/key-papers/paper-ohba-herb-trastuzumab-deruxtecan-biliary-jco-2024/  
OnCo record `paper-ohba-herb-trastuzumab-deruxtecan-biliary-jco-2024` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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%).

32 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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: Journal of Clinical Oncology
- Year: 2024
- DOI: 10.1200/jco.23.02010
- Authors: Ohba A, Morizane C, Kawamoto Y, et al.
- 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.
- What it means: 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.

## Sources

- Ohba et al., J Clin Oncol 2024: trastuzumab deruxtecan in HER2-expressing biliary tract cancer (HERB): https://doi.org/10.1200/jco.23.02010
- PubMed: https://pubmed.ncbi.nlm.nih.gov/39102634/

## Connected records

- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- institutions: [National Cancer Center Hospital](https://onco.cc/institutions/ncc-japan/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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