NAVIGATE-PANC

NCT02576431 📎

Regimen

Experimental
Larotrectinib 100 mg PO BID (adults) / 100 mg/m² BID (pediatric)
Control
single-arm / no comparator (historical benchmark for chemo-refractory PDAC = ORR <10%)

Population

TRK fusion-positive locally advanced/metastatic solid tumors pooled across NAVIGATE (NCT02576431), SCOUT pediatric (NCT02637687), and phase 1 (NCT02122913); overall N=159, pancreatic subset n=3 (NTRK fusion in PDAC is ultra-rare, <0.5%). Hong/Drilon Lancet Oncol 2020.

Key finding

Supported FDA tissue-agnostic approval of larotrectinib for NTRK fusion-positive advanced solid tumors (2018). In PDAC specifically, the signal is limited by ultra-rare NTRK fusion prevalence (<0.5% of PDAC); data from case reports + registries (not the pooled trial) have since confirmed deep and durable responses in individual PDAC pts with NTRK fusions. Rationale for comprehensive fusion testing at PDAC diagnosis.

Source: PMID 32105622

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.65)