Table 3.

Preliminary clinical activity

OutcomeFGF19-positive (n = 66)FGF19-negative/unknowna (n = 32)
Best response, n (%)
 Overall response rate11 (17)0 (0)
  Complete response1 (2)0 (0)
  Partial response10 (15)0 (0)
 Stable disease30 (45)16 (50)
 Progressive disease25 (38)16 (50)
Median DOR (95% CI), months5.3 (3.7–NE)
Median PFS (95% CI), months3.3 (2.1–3.7)2.3 (1.8–5.5)
  • Abbreviations: DOR, duration of response; NE, not estimable.

  • aThree patients had unknown FGF19 status; 1 patient had FGF19 that was not evaluable.