Table 2.

Clinical activity among patients in the ipilimumab and BSC treatment arms

Ipilimumab 10 mg/kg (n = 57)BSC (n = 57)
Best overall response,a n (%)
 CR0 (0.0)0 (0.0)
 PR1 (1.8)4 (7.0)
 SD18 (31.6)23 (40.4)
 PD23 (40.4)11 (19.3)
 Unknown15 (26.3)19 (33.3)
Overall response rate, n/N (%; 95% CI)1/57 (1.8; 0.91–1.00)4/57 (7.0; 0.83–0.98)
Time to progression, months
 Number of events/number of patients, n/N (%)37/57 (64.9)25/57 (43.9)
 Median2.86 (1.41–4.24)5.19 (4.07–9.69)
Duration of response, mo
 Number of responders, n (%)1 (1.8)4 (7.0)
 Median (95% CI)NE (NE–NE)NE (8.3–NE)
  • Abbreviations: CI, confidence interval; NE, not estimable.

  • aDetermined by independent review committee.