NAVIGATE
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.
Overview
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.
- 75 out of 100 people had their tumour shrink with Larotrectinib.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: TRK fusion-positive solid tumours in adults and children, any tumour type: larotrectinib single-arm basket trial. People in a different situation may not see the same effect.
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.
215 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate (independent review, pooled with LOXO-TRK-14001 and SCOUT)primary | Larotrectinib | 55 | 75% | - | - | link |
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