STARTRK-ENTRECTINIB

NCT02568267 📎

Regimen

Experimental
Entrectinib 600 mg PO QD (continuous) — pan-TRK/ROS1/ALK inhibitor (broader kinase spectrum than larotrectinib)
Control
single-arm / no comparator

Population

NTRK fusion-positive advanced solid tumors; integrated analysis of 3 trials (Doebele RC, Lancet Oncol 2020). BTC/CCA subgroup: not specifically reported in primary analysis due to small N (<3% of enrolled); entrectinib's tumor-agnostic registration included heterogeneous histologies. NTRK fusions detected by RNA-based NGS or DNA-based platforms.

Key finding

Entrectinib received FDA tumor-agnostic approval for NTRK fusion-positive solid tumors in August 2019, with CNS activity as a distinguishing feature vs larotrectinib (given entrectinib's CNS penetrance). The overall ORR (57%) is lower than larotrectinib (75%), likely reflecting less-selective kinase binding and broader patient populations with lower fusion-driver dependency. For BTC patients with NTRK fusions (rare, <1%), both larotrectinib and entrectinib are options; CNS-active entrectinib may be preferred in cases with brain metastases.

Source: PMID 31838007

Timeline

    Guideline citations

    • NCCN BTC (p.34)