Table 1.
Comparison of efficacy and toxicity between the global phase III study with nivolumab in relapsed non-squamous NSCLC (Checkmate 057)3 and the corresponding Japanese data
| Checkmate 057 | JapicCTI-132073 | ||
|---|---|---|---|
| n=292 | n=76 | ||
| Objective response rate | |||
| Proportion (%) | 19 * | 22 † | |
| Median duration (months) | 17.2 | Not reached | |
| Time to response (months) | 2.1 | 1.4 | |
| Progression-free survival | |||
| Median (months) | 2.3 | 2.8 | |
| 1 year (%) | 19 | 24 | |
| Overall survival | |||
| Median (months) | 12.2 | 17.1 | |
| 1 year (%) | 51 | 68 | |
| Safety | |||
| All TRAEs (%) | 69 | 84 | |
| Grade 3–4 TRAEs (%) | 10 | 22 | |
| Discontinued for AEs (%) | 5 | 16 | |
| All pneumonitis (%) | 3 | 8 | |
| Grade 3–4 pneumonitis (%) | 1 | 3 | |
*Investigator assessed.
†Independent review committee assessed.
AEs, adverse events; NSCLC, non-small cell lung cancer; TRAEs, treatment-related adverse events