Table 5.
Efficacy outcomes in Japanese patients who discontinued study treatment due to TRAEsa (PD-L1 ≥ 1% and < 1%)
| Nivolumab plus ipilimumab (n = 17) |
Chemotherapy (n = 13) |
|
|---|---|---|
|
Median OSb, months (95% CI) |
NR |
33.2 (7.7–NR) |
| 5-year OS rateb, % | 58 | 38 |
|
Median PFS after discontinuationb, months (95% CI) |
54.3 (0.8–NR) |
2.0 (0.8–NR) |
| ORR, % | 65 | 38 |
|
Median DORc after discontinuation, months (95% CI) |
NR |
1.5 (0.1–NR) |
|
Ongoing responsed at ≥ 3 years after discontinuation, % (95% CI) |
79 (38–94) |
NA |
aIncludes patients with TRAEs reported between first dose and 30 days after last dose of study therapy who discontinued treatment due to study drug toxicity. bBased on Kaplan–Meier estimates. cComputed using Kaplan–Meier method. dBased on Kaplan–Meier estimates of DOR
CI confidence interval; DOR duration of response; NA not applicable; NR not reached; ORR objective response rate; OS overall survival; PD-L1 programmed death ligand 1; PFS progression-free survival; TRAE treatment-related adverse event