Table 3.
Subgroup analysis of ORR from available data
| Subgroup | No. of Studies | RR (95% CI) | Weight (%) | Heterogeneity within subgroup | ||
|---|---|---|---|---|---|---|
| Criteria | Characteristics | I 2 (%) | P value | |||
| Experimental drug | Anti‐CTLA‐4 | 3 | 0.95 (0.88, 1.02) | 51.6 | 50 | 0.13 |
| Anti‐PD‐1 | 3 | 0.76 (0.69, 0.84) | 48.4 | 54 | 0.12 | |
| Subgroup difference | P < 0.00001c | |||||
| Ipilimumab naïve versus refractory diseasea | Ipilimumab naïve | 1 | 0.70 (0.62, 0.79) | 30.5 | NA | NA |
| Ipilimumab refractory | 2 | 0.80 (0.75, 0.85) | 69.5 | 0 | 0.78 | |
| Subgroup Difference | P = 0.05c | |||||
| BRAF mutationa | BRAF wild‐type | 2 | 0.84 (0.68, 1.03) | 81.4 | 76 | 0.04 |
| BRAF mutant | 1 | 0.85 (0.64, 1.12) | 18.6 | NA | NA | |
| Subgroup Difference | P = 0.97 | |||||
| PD‐L1 statusa | PD‐L1 positiveb | 2 | 0.57 (0.48, 0.69) | 45.4 | 0 | 0.38 |
| PD‐L1 negative | 2 | 0.84 (0.73, 0.96) | 54.6 | 29 | 0.24 | |
| Subgroup Difference | P = 0.001c | |||||
a
Data from nivolumab and pembrolizumab trials were used for these subgroup analyses.
b
PD‐L1 positivity was defined as at least 5% of tumor cells exhibiting cell surface PD‐L1 staining of any intensity in a section containing at least 100 evaluable cells. Patients with indeterminate PD‐L1 expression level were included into PD‐L1‐negative group for the subgroup analysis in study performed by Robert et al 45.
c
Statistically significant.
CTLA‐4, cytotoxic T lymphocyte‐associated protein‐4; PD‐1, programmed cell death‐1; PD‐L1, PD‐ligand 1; RR, risk ratio; BRAF, v‐raf murine sarcoma viral oncogene homolog B1).