Table 2. TRK inhibitors in selected clinical studies.
| Study/author | Treatment | Design | No. of pts. | ORR (%) | PFS (months) | OS (months) | trAEs (% gr.3–5) |
|---|---|---|---|---|---|---|---|
| Drilon et al. (28) | Larotrectinib | Phase 1/2 | 55 | 75 | NA | NA | gr.3: 13%, gr.4–5: 0% |
| Lassen et al. (31) | Larotrectinib | Phase 1/2 | 122 | 81 | NA | NA | gr.3: 6%+ <1% for fatigue, dizziness, myalgia, gr.4:<1% ALT increase, gr.5: 0% |
| Hong et al. (32) | Larotrectinib | Phase 1/2 | 159 | 79 | 28.3 (22.1–NE) | 44.4 (36.5–NE) | gr.3: 39%, gr.4: 7%, gr.5: 0% |
| Demetri et al. (33) | Entrectinib | Phase 1/2 | 54 | 57.4 | 11.2 (8.0–14.9) | 20.9 (14.9–NE) | gr.3: 37%, gr.4: 1.5%, gr.5: 0% |
| Doebele et al. (34) | Entrectinib | Phase 1/2 | 54 | 57 | 11.2 (8.0–14.9) | Estimated 21 (14.9–NE) | gr.3: 61%, gr.4: 9%, gr.5: 0% |
| Hyman et al. (35) | Selitrectinib | Phase I + EAP | 29 | 34 | NA | NA |
In brackets for PFS and OS, 95% CI. TRK, tropomyosin receptor kinase; ORR, overall response rate; PFS, progression-free survival; OS, overall survival; NA, not available; EAP, Early Access Program; trAEs, treatment-related adverse events; gr., grade; CI, confidence interval; NE, not estimable.