Table 2.
Efficacy of TRK inhibitors in patients with sarcoma harboring NTRK gene fusionsa
| Larotrectinib n = 7143 |
Entrectinib n = 1347 |
|
|---|---|---|
| Objective response rate, % | 87 (95% CI 77–94) | 46 (95% CI 19–75) |
| Median duration of response, months | NE (range 1.6+ to 44.2+) | 10.3 (95% CI 4.6–15.0) |
| Median progression-free survival, months | 28.3 (95% CI 16.8-NE) | 11.0 (95% CI 6.5–15.7) |
| Median overall survival, months | 44.4 (95% CI 44.4-NE) | 16.8 (95% CI 10.6–20.9) |
CI, confidence interval; MPS, massive parallel sequencing; NE, not estimable; NTRK, neurotrophic tyrosine receptor kinase receptor; PCR, polymerase chain reaction; TRK, tropomyosin receptor kinase.
In the larotrectinib clinical trials, NTRK gene fusions were detected by local MPS, according to the procedures and analytic pipelines established by each laboratory, or by FISH. All tests were carried out in a Clinical Laboratory Improvement Amendments-certified (or equivalent) laboratory. In the entrectinib clinical trials, NTRK gene fusions were detected by central RNA MPS (Trailblaze Pharos, Ignyta, San Diego, CA, USA) or local molecular testing (FISH, quantitative PCR, or DNA or RNA MPS).