Table 2.

Primary, secondary, and exploratory efficacy endpoints

EndpointCohort 1 prior platinum therapy (n = 48)Cohort 2 third-line treatment, no. prior platinum therapy (n = 35)Total (N = 83)
Primary efficacy endpoint, ORR assessed by independent radiology facility
ORR, % (95% CI)21 (10–35)37 (22–55)28 (18–39)
Best overall response, n (%)
 Complete response2 (4)02 (2)
 Partial response8 (17)13 (37)21 (25)
 Stable disease18 (38)18 (51)36 (43)
 Progressive disease18 (38)4 (11)22 (27)
 Not evaluable2 (4)02 (2)
Secondary efficacy endpoints (intention-to-treat population)
Duration of response assessed by independent radiology facility
 No.101323
 Events, n (%)5 (50)10 (77)15 (65)
 Median (95% CI), months5.8 (2.8–NE)3.8 (2.8–10.1)4.9 (2.9–9.7)
Clinical benefit rate assessed by independent radiology facility (complete response, partial response, or stable disease ≥24 weeks), no. (%)13 (27)16 (46)29 (35)
 95% CI15–4229–6325–46
Exploratory endpoint, investigator assessments of efficacy (tumor-evaluable population)Cohort 1 prior platinum therapy (n = 48)Cohort 2 third-line treatment, no. prior platinum therapy (n = 35)Total (N = 83)
ORR, % (95% CI)23 (12–37)51 (34–69)35 (25–46)
Duration of response
 No.111829
 Events, n (%)8 (73)15 (83)23 (79)
Median (95% CI), months4.9 (2.8–NE)4.2 (3.2–5.5)4.4 (3.2–5.6)
Clinical benefit rate assessed by investigator (complete response, partial response, or stable disease ≥24 weeks), n (%)18 (38)23 (66)41 (49)
 95% CI24–5348–8138–61
  • NOTE: Confirmation of complete response and partial response required; data cutoff for primary endpoint was September 1, 2016.

  • Abbreviations: NE, not evaluable.