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DESTINY-PanTumor02

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02): biliary tract cancer cohort

Phase 2NCT04482309

Population
Biliary tract cancer cohort of DESTINY-PanTumor02: locally advanced, unresectable or metastatic HER2-expressing (IHC 3+ or 2+) disease that progressed after at least one systemic treatment or had no satisfactory alternative.
Design
Open-label, multicentre phase 2 study with seven tumour cohorts (267 patients treated overall); this record covers the biliary tract cancer cohort (cohort 1 of part 1 in the registry; the cohort's size is not given in the text read). Trastuzumab deruxtecan 5.4 mg/kg once every 3 weeks in HER2-expressing (immunohistochemistry 3+ or 2+, local or central testing) disease after at least one systemic treatment or without alternative treatments. Primary endpoint: investigator-assessed confirmed objective response rate. Median follow-up 12.75 months across all cohorts; data cutoff 8 June 2023. Single-arm; no comparison group.
Primary endpoint
ORR
Arms
  • Trastuzumab deruxtecan (experimental): Trastuzumab deruxtecan 5.4 mg/kg intravenously once every 3 weeks
People
Meric-Bernstam F
Show the numbers
Results reported for DESTINY-PanTumor02
EndpointAnalysisTrastuzumab deruxtecanControlEffect
ORRBiliary tract cancer cohort, all patients treatedConfirmed objective response by investigator assessment (RECIST 1.1)primaryMeric-Bernstam 202422% (10.6–37.6%)—The same cohort's ORR by independent central review was 26.8% (95% CI 14.2 to 42.9). The abstract reports only the pooled all-tumour results.
ORRBiliary tract cancer cohort, patients with centrally confirmed HER2 IHC 3+ expression (16)exploratoryMeric-Bernstam 202456.3% (29.9–80.2%)—Investigator-assessed; from the subgroup analysis by central HER2 IHC status, which the paper lists among its exploratory end points. Sixteen patients, so the interval is wide.
Results reported for DESTINY-PanTumor02
EndpointAnalysisTrastuzumab deruxtecanControlEffect
ORRBiliary tract cancer cohort, all patients treatedConfirmed objective response by investigator assessment (RECIST 1.1)primaryMeric-Bernstam 202422% (10.6–37.6%)—The same cohort's ORR by independent central review was 26.8% (95% CI 14.2 to 42.9). The abstract reports only the pooled all-tumour results.
ORRBiliary tract cancer cohort, patients with centrally confirmed HER2 IHC 3+ expression (16)exploratoryMeric-Bernstam 202456.3% (29.9–80.2%)—Investigator-assessed; from the subgroup analysis by central HER2 IHC status, which the paper lists among its exploratory end points. Sixteen patients, so the interval is wide.
Primary publication: Meric-Bernstam F, Makker V, Oaknin A, Oh DY, Banerjee S, González-Martín A, et al. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial. J Clin Oncol. 2024;42(1):47-58. PubMedDOI

Appears in

Sources

  1. Meric-Bernstam F, Makker V, Oaknin A, Oh DY, Banerjee S, González-Martín A, et al. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial. J Clin Oncol. 2024;42(1):47-58.

    PubMedDOI