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HERB

Trastuzumab Deruxtecan in Human Epidermal Growth Factor Receptor 2-Expressing Biliary Tract Cancer (HERB; NCCH1805): A Multicenter, Single-Arm, Phase II Trial

Phase 2N = 32

Population
Patients with pathologically confirmed unresectable or recurrent biliary tract cancer refractory or intolerant to gemcitabine-containing therapy: 22 with centrally confirmed HER2-positive disease (primary efficacy population) and 8 with HER2-low disease (exploratory).
Design
Multicentre, single-arm phase 2 trial at five institutions in Japan of trastuzumab deruxtecan 5.4 mg/kg once every 3 weeks until progression or unacceptable toxicity in unresectable or recurrent biliary tract cancer that was refractory or intolerant to a gemcitabine-containing regimen, with centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and in-situ hybridisation positive) or HER2-low disease. Primary endpoint: confirmed objective response rate in HER2-positive disease by independent central review (threshold 15%, expected 40%). Single-arm; no comparison group.
Primary endpoint
ORR
Arms
  • Trastuzumab deruxtecan (experimental, n = 32): Trastuzumab deruxtecan 5.4 mg/kg intravenously once every 3 weeks
People
Ohba A
Show the numbers
Results reported for HERB
EndpointAnalysisTrastuzumab deruxtecanControlEffect
ORRHER2-positive primary efficacy population (22)Confirmed objective response rate by independent central reviewprimaryOhba 202436.4%—P=.0190% confidence interval 19.6 to 56.1 (not a 95% interval); P tested against the 15% threshold, which the trial met.
ORRHER2-low exploratory population (8)exploratoryOhba 202412.5%—Defined in the abstract as IHC 2+ and ISH-negative, IHC 1+, or IHC 0 and ISH-positive; eight patients, no interval in the abstract.
Results reported for HERB
EndpointAnalysisTrastuzumab deruxtecanControlEffect
ORRHER2-positive primary efficacy population (22)Confirmed objective response rate by independent central reviewprimaryOhba 202436.4%—P=.0190% confidence interval 19.6 to 56.1 (not a 95% interval); P tested against the 15% threshold, which the trial met.
ORRHER2-low exploratory population (8)exploratoryOhba 202412.5%—Defined in the abstract as IHC 2+ and ISH-negative, IHC 1+, or IHC 0 and ISH-positive; eight patients, no interval in the abstract.
Primary publication: Ohba A, Morizane C, Kawamoto Y, Komatsu Y, Ueno M, Kobayashi S, et al. Trastuzumab Deruxtecan in Human Epidermal Growth Factor Receptor 2-Expressing Biliary Tract Cancer (HERB; NCCH1805): A Multicenter, Single-Arm, Phase II Trial. J Clin Oncol. 2024;42(27):3207-3217. PubMedDOI

Appears in

Sources

  1. Ohba A, Morizane C, Kawamoto Y, Komatsu Y, Ueno M, Kobayashi S, et al. Trastuzumab Deruxtecan in Human Epidermal Growth Factor Receptor 2-Expressing Biliary Tract Cancer (HERB; NCCH1805): A Multicenter, Single-Arm, Phase II Trial. J Clin Oncol. 2024;42(27):3207-3217.

    PubMedDOI