MYPATHWAY-BTC

NCT02091141 📎

Regimen

Experimental
Pertuzumab 840 mg IV loading then 420 mg IV q21d + trastuzumab 8 mg/kg IV loading then 6 mg/kg IV q21d (both given q3w until PD or intolerance)
Control
single-arm / no comparator

Population

HER2-positive (IHC 3+ or IHC 2+/FISH+) previously treated advanced BTC; BTC cohort n=39 of 251 total MyPathway patients. All BTC subtypes; GBC and ECC more prevalent than ICC given HER2 biology. Median 2 prior lines. Published as dedicated BTC-cohort analysis (Javle M, Lancet Oncol 2021).

Key finding

MyPathway was the first prospective evidence for dual anti-HER2 blockade (pertuzumab + trastuzumab) in BTC, preceding later dedicated BTC trials. ORR 23.1% established proof-of-concept for HER2 targeting in BTC but was lower than subsequently reported for zanidatamab or tucatinib combinations. The IHC 2+/FISH+ inclusion (not just IHC 3+) may have diluted the signal. This basket cohort data contributed to the clinical rationale for larger dedicated BTC HER2 trials.

Source: PMID 34339623

Timeline

    Guideline citations

    • NCCN BTC (p.34)