Table 2

Tumor response according to independent review per RECIST 1.1

ResponsePatients (N=116)
Best overall response, n (%)
 Complete response19 (16.4)
 Partial response27 (23.3)
 Stable disease12 (10.3)
 Noncomplete response/nonprogressive disease1 (0.9)
 Progressive disease48 (41.4)
 Not evaluable9 (7.8)*
Objective response rate (95% CI), %39.7 (30.7–49.2)
Patients with response, n46
Median duration of response (95% CI), months†18.2 (11.3-not estimable)
 Range1.2–28.3
Proportion with duration of response (95% CI), %†
 ≥6 months78 (63–87)
 ≥12 months66 (50–78)
 ≥18 months52 (34–67)
 ≥24 months45 (25–63)
Patients with durable response, n35
Durable response rate (95% CI), %‡30.2 (22.0–39.4)
  • *No post-baseline assessments due to early death (n=4) or other reasons (n=2), no adequate baseline assessment (n=2), or all post-baseline assessments had overall response of not evaluable (n=1).

  • †Based on Kaplan-Meier estimates.

  • ‡Proportion of patients with a response lasting ≥6 months.

  • RECIST 1.1, Response Evaluation Criteria in Solid Tumors version 1.1.