Table 1.
Study | Study type | Treatment arms | Indication | All-grade (grades 1–4) pneumonitis | High-grade (grades 3–4) pneumonitis |
---|---|---|---|---|---|
1. Ipilimumab studies | |||||
Kwon et al. [2014] | Phase III | Arm A: ipilimumab 10 mg/kg (393 pts) Arm B: placebo (396 pts) |
Metastatic castration-resistant prostate cancer | 5 (1.3%) versus 0 | 1 (0.3%) versus 0 |
2. Nivolumab studies | |||||
Robert et al. [2015a] | Phase III | Arm A: nivolumab 3 mg/kg of body weight every 2 weeks (206
pts) Arm B: dacarbazine (205 pts) |
Stage III or IV unresectable melanoma without a BRAF mutation. | 3 (1.5%) versus 0 | 0 versus 0 |
Weber et al. [2015] | Phase III | Arm A: nivolumab 3 mg/kg of body weight every 2 weeks (268
pts) Arm B: investigator choice chemotherapy (102 pts) |
Patients with advanced melanoma who progressed after anti-CTLA-4 treatment | 5 (1.9%) versus 0 | 0 versus 0 |
Brahmer et al. [2015] | Phase III | Arm A: nivolumab 3 mg/kg of body weight every 2 weeks (131
pts) Arm B: docetaxel (129 pts) |
Advanced squamous cell NSCLC | 6 (5%) versus 0 | 0 versus 0 |
Borghaei et al. [2015] | Phase III | Arm A: nivolumab 3 mg/kg of body weight every 2 weeks (292
pts) Arm B: docetaxel (290 pts) |
Advanced non squamous cell NSCLC | 8 (3%) versus 1 (<1%) | 3 (1%) versus 1 (<1%) |
Motzer et al. [2015] | Phase III | 821 patients were randomly assigned (in a 1:1 ratio) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10 mg everolimus tablet orally once daily | Advanced clear-cell renal cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy | 16 (4%) versus 58 (15%) | 6 (1%) versus 11 (3%) |
3. Pembrolizumab studies | |||||
Ribas et al. [2015] | Randomized phase II | Arm A: pembrolizumab (low dose 2 mg/kg): 179 pts Arm B: pembrolizumab (high dose 10 mg/kg):178 pts Arm C: chemotherapy control: 171 pts |
Ipilimumab-refractory advanced melanoma | 3 (2%) versus 3(2%) versus 0 | 0 versus 2(1%) versus 0 |
Herbst et al. [2015] | Randomized phase II/III study | Arm A: pembrolizumab (low dose 2 mg/kg): 344 pts Arm B: pembrolizumab (high dose3 mg/kg ):346 pts Arm C: Docetaxel: 343 pts |
Previously treated NSCLC with PD-L1>1% | 16 (5%) versus 15 (4%) versus 6 (2%) | 7 (2%) versus 7 (2%) versus 2 (1%) |
CTLA-4, cytotoxic T lymphocyte antigen-4; NSCLC, non-small cell lung cancer; PD-L1, programmed death ligand 1; pts, patients.