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The basket trial behind the first tumour-agnostic TRK inhibitor approval: larotrectinib shrank tumours in three of four patients whatever the organ, as long as the cancer carried an NTRK gene fusion.
NAVIGATE, trial NCT02576431 sponsored by Bayer through Loxo Oncology, enrolled adults and children with TRK fusion-positive solid tumours of any type. Its early results were pooled with the adult phase 1 study and the paediatric SCOUT trial in the New England Journal of Medicine in 2018: 75% of the first 55 patients responded on independent review across 17 tumour types, and most responses were durable. The data supported the 2018 US accelerated approval of larotrectinib, the first treatment approved for a genomic marker regardless of tumour site, and the 2019 EU approval.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Shares Larotrectinib, Bayer, Comprehensive genomic profiling, Metastatic cancer (cancer that has spread).
Shares Basket trial, Single-arm trial, Objective response rate (ORR), Basket, umbrella, and platform trials.
Shares Basket trial, Single-arm trial, Phase 1, 2 and 3 trials, Basket, umbrella, and platform trials.
Shares Basket trial, Single-arm trial, Lung cancer (all types), Small-molecule kinase inhibitors.
Shares NTRK fusion-positive non-small-cell lung cancer, Larotrectinib.
Shares NTRK fusion-positive non-small-cell lung cancer, Metastatic cancer (cancer that has spread), Lung cancer (all types), Small-molecule kinase inhibitors.
Shares Bayer, Metastatic cancer (cancer that has spread), Small-molecule kinase inhibitors.
Shares Clinical equipoise, Trial lifecycle: from protocol to label, Phase 1, 2 and 3 trials.