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MyPathway

Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study

Phase 2N = 39NCT02091141

Population
Adults with previously treated metastatic biliary tract cancer with HER2 amplification, HER2 overexpression, or both, and ECOG performance status 0-2 (39 evaluable for anti-tumour activity).
Design
Non-randomised, multicentre, open-label phase 2a multiple-basket study at 23 US sites; this record covers the HER2-positive metastatic biliary tract cancer cohort given pertuzumab (840 mg loading dose, then 420 mg every 3 weeks) plus trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks). Primary endpoint: investigator-assessed objective response rate by RECIST 1.1. Data cutoff 10 March 2020. The registry record covers all tumour types (673 enrolled). Single-arm; no comparison group.
Primary endpoint
ORR
Arms
  • Pertuzumab plus trastuzumab (experimental, n = 39): Pertuzumab 840 mg loading dose then 420 mg every 3 weeks plus trastuzumab 8 mg/kg loading dose then 6 mg/kg every 3 weeks
People
Javle M
Show the numbers
Results reported for MyPathway
EndpointAnalysisPertuzumab plus trastuzumabControlEffect
ORRHER2-positive biliary tract cancer cohort evaluable by the March 2020 data cutoff (39)Investigator-assessed objective response (RECIST 1.1)primarymedian follow-up 8.1 monthsJavle 202123% (11–39%)—Nine of 39 patients had a partial response.
Results reported for MyPathway
EndpointAnalysisPertuzumab plus trastuzumabControlEffect
ORRHER2-positive biliary tract cancer cohort evaluable by the March 2020 data cutoff (39)Investigator-assessed objective response (RECIST 1.1)primarymedian follow-up 8.1 monthsJavle 202123% (11–39%)—Nine of 39 patients had a partial response.
Primary publication: Javle M, Borad MJ, Azad NS, Kurzrock R, Abou-Alfa GK, George B, et al. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021;22(9):1290-1300. PubMedDOI

Appears in

Sources

  1. Javle M, Borad MJ, Azad NS, Kurzrock R, Abou-Alfa GK, George B, et al. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021;22(9):1290-1300.

    PubMedDOI