Table 3.
Efficacy endpoint (by RECIST v1.1) at week 37 (PL3397-A-A303 and phase 3 ENLIVEN studies)
| PL3397-A-A303 | Phase 3 ENLIVEN study | |
|---|---|---|
| % (95% CI) | Pexidartinib (N = 40) | Pexidartinib (part 1) (N = 61) |
| ORR (CR or PR) | 35.0 (20.6–51.7) | 42.6 (30.0–55.9) |
| CR | 5.0 (0.6–16.9) | 14.8 (7.0–26.2) |
| PR | 30.0 (16.6–46.5) | 27.9 (17.1–40.8) |
| Sd | 27.5 (14.6–43.9) | 32.8 (21.3–46.0) |
| PD | 2.5 (0.1–13.2) | 1.6 (0–8.8) |
| NE | 35.0 (20.6–51.7) | 23.0 (13.2–35.5) |
CI, confidence interval; CR, complete response; NE, not evaluable; ORR, overall response rate; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; Sd, stable disease