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. 2025 Aug 21;13(4):1025–1039. doi: 10.1007/s40487-025-00365-z

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