Table 1.
Primary efficacy data for the non-randomized (n = 135) and randomized melanoma cohorts (n = 520) from KEYNOTE-001 [41–43, 45, 46]
| Cohort | n | ORR |
|---|---|---|
| % (95% CI) | ||
| B1 (non-randomized)a | ||
| Ipi-N | ||
| 10 mg/kg Q2W | 39 | 49 (32–65) |
| 10 mg/kg Q3W | 19 | 26 (9–51) |
| 2 mg/kg Q3W | 20 | 25 (9–49) |
| Ipi-T | ||
| 10 mg/kg Q2W | 13 | 62 (32–86) |
| 10 mg/kg Q3W | 26 | 27 (12–48) |
| B2 (randomized)b | ||
| Ipi-R | ||
| 2 mg/kg Q3W | 81 | 26 (17–37) |
| 10 mg/kg Q3W | 76 | 26 (17–38) |
| D (randomized)b | ||
| Ipi-N | ||
| 2 mg/kg Q3W | 51 | 33 (20–49) |
| 10 mg/kg Q3W | 52 | 40 (26–56) |
| B3 (randomized)c | ||
| Ipi-N | ||
| 10 mg/kg Q3W | 57 | 35 (23–49) |
| 10 mg/kg Q2W | 56 | 38 (25–52) |
| Ipi-T | ||
| 10 mg/kg Q3W | 50 | 26 (15–40) |
| 10 mg/kg Q2W | 61 | 33 (21–46) |
| Pooled analysis of cohorts B1, B2, D, and B3 (N = 655)d | 581 | 33 (30–37) |
| Ipi-N | 277 | 39 (33–45) |
| Ipi-T | 304 | 29 (24–34) |
| Treatment-naive | 133 | 45 (36–54) |
a
Data cutoff, March, 2013.
b
Data cutoff, October 18, 2013.
c
Data cutoff, April 18, 2014.
d
Data cutoff, October 18, 2014.
CI, confidence interval; Ipi-N, ipilimumab naive; Ipi-R, ipilimumab refractory; Ipi-T, ipilimumab treated; ORR, overall response rate; Q2W, every 2 weeks; Q3W, every 3 weeks.