Table 2. Best Response to Treatment and Time-to-Event Data✫.
| Response and Time to Event | Ipilimumab plus gp100 (N = 403) |
Ipilimumab Alone (N = 137) |
gp100 Alone (N = 136) |
|---|---|---|---|
| Overall survival | |||
| Total no. of deaths | 306 | 100 | 119 |
| Comparison with gp100 alone | |||
| Hazard ratio (95% CI) | 0.68 (0.55–0.85) | 0.66 (0.51–0.87) | — |
| P value by log-rank test | <0.001 | 0.003 | — |
| Comparison with ipilimumab alone | |||
| Hazard ratio (95% CI) | 1.04 (0.83–1.30) | — | — |
| P value by log-rank test | 0.76 | — | — |
| Evaluation of therapy | |||
| Induction | |||
| Best overall response — no. (%) | |||
| Complete response | 1 (0.2) | 2 (1.5) | 0 |
| Partial response | 22 (5.5) | 13 (9.5) | 2 (1.5) |
| Stable disease | 58 (14.4) | 24 (17.5) | 13 (9.6) |
| Progressive disease | 239 (59.3) | 70 (51.1) | 89 (65.4) |
| Not evaluated | 83 (20.6) | 28 (20.4) | 32 (23.5) |
| Best overall response rate — % (95% CI) | 5.7 (3.7–8.4) | 10.9 (6.3–17.4) | 1.5 (0.2–5.2) |
| P value for comparison with gp100 alone | 0.04 | 0.001 | — |
| P value for comparison with ipilimumab alone | 0.04 | — | — |
| Disease control rate — % (95% CI)† | 20.1 (16.3–24.3) | 28.5 (21.1–36.8) | 11.0 (6.3–17.5) |
| P value for comparison with gp100 alone | 0.02 | <0.001 | — |
| P value for comparison with ipilimumab alone | 0.04 | — | — |
| Time to event — mo | |||
| Time to progression — median (95% CI) | 2.76 (2.73–2.79) | 2.86 (2.76–3.02) | 2.76 (2.73–2.83) |
| Time to response — mean (95% CI) | 3.32 (2.91–3.74) | 3.18 (2.75–3.60) | 2.74 (2.12–3.37) |
| Duration of response — median (95% CI) | 11.5 (5.4–NR) | NR (28.1–NR) | NR (2.0–NR) |
| Reinduction‡ | |||
| Best overall response — no./total no. (%) | |||
| Complete response | 0 | 1/8 (12.5) | 0 |
| Partial response | 3/23 (13.0) | 2/8 (25.0) | 0 |
| Stable disease | 12/23 (52.2) | 3/8 (37.5) | 0 |
| Progressive disease | 8/23 (34.8) | 2/8 (25.0) | 1/1 (100.0) |
Of the 143 patients who could not be evaluated for a response, 33 patients did not receive any study drug and 110 patients did not have baseline or week-12 tumor assessments (or both). Percentages may not total 100 because of rounding. NR denotes not reached.
The disease control rate is the percentage of patients with a partial or complete response or stable disease.
A total of 40 patients (29 in the ipilimumab-plus-gp100 group; 9 in the ipilimumab-alone group, and 2 in the gp100-alone group) were given reinduction therapy, but 8 were not included in the efficacy analyses: 3 had major protocol violations and 5 were not eligible owing to the fact that they had had a best overall response of progressive disease during induction and were given reinduction therapy inadvertently.