Table 2.
Study | Phase | Treatment arms | Indication | All-grade (grades 1–4) pneumonitis | High-grade (grades 3–4) pneumonitis |
---|---|---|---|---|---|
Robert et al. [2015b] | Phase III | 834 patients with advanced melanoma in a 1:1:1 ratio to
receive: • Arm A: pembrolizumab 10 mg/kg every 2 weeks (279 pts) • Arm B: pembrolizumab 10 mg/kg every 3 weeks (277 pts) • Arm C: ipilimumab (278 pts) |
Advanced melanoma | 1 (0.4%) versus 5 (1.8%) versus 1 (0.4%) | 0 versus 1(0.4%) versus 1(0.4%) |
Larkin et al. [2015] | Phase III | 945 patients were randomized in a 1:1:1 fashion
into: • Nivolumab 3mg/kg combined with placebo (316 pts) • Ipilimumab (3 mg/kg) combined with nivolumab (1 mg/kg) (314 pts) • Ipilimumab (3 mg/kg) combined with placebo (315 pts) |
Advanced melanoma | 4 (1.3%) versus 20 (6.4%) versus 5 (1.6%) | 1 (0.3%) versus 3 (1%) versus 1 (0.3%) |
Postow et al. [2015] | Phase III | 142 patients were randomized in a 2:1 fashion into
: • Ipilimumab (3 mg/kg) combined with nivolumab (1 mg/kg) (94 pts) • Ipilimumab (3 mg/kg) combined with placebo (46 pts) |
Advanced melanoma | 10 (11%) versus 2 (4%) | 2 (2%) versus 1(2%) NB One patient in the combination arm has died of drug-related pneumonitis. |
pts, patients.