Table 2.
Impact of imAEs and systemic corticosteroid use for imAEs on PFS and OS in patients on pembrolizumab therapy at week 21.
| Any-grade imAEs |
Systemic corticosteroid for imAEs |
|||
|---|---|---|---|---|
| Yes (n = 79) | No (n = 384) | Yes (n = 17) | No (n = 62) | |
| PFSa | ||||
| No. of events | 51 | 227 | 12 | 39 |
| Median, months (95% CI) | 17.0 (12.1‒23.6) | 17.7 (15.4‒20.1) | 9.9 (6.8‒23.6) | 17.0 (13.6‒25.8) |
| Comparison of PFS | Yes vs. no | Yes vs. no | ||
| HR (95% CI)b | 0.98 (0.72‒1.33) | 1.45 (0.76‒2.79) | ||
| p valuec | 0.4522 | 0.8692 | ||
| OSa | ||||
| No. of events | 26 | 154 | 5 | 21 |
| Median, months (95% CI) | NR (38.2‒NR) | 43.0 (37.9‒NR) | NR (13.8‒NR) | NR (34.3‒NR) |
| Comparison of OS | Yes vs no | Yes vs no | ||
| HR (95% CI)b | 0.77 (0.51‒1.17) | 0.86 (0.32‒2.28) | ||
| p valuec | 0.1104 | 0.3799 | ||
AE, adverse event; CI, confidence interval; HR, hazard ratio; imAEs, immune-mediated adverse events; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.
a
From product-limit (Kaplan-Meier) method for censored data.
b
Based on Cox regression model with treatment as a covariate.
c
One-sided p value based on log-rank test.