Table 2.
TTDM and ORR in patients with or without stage IIIA-N2 NSCLC
| Patients with stage IIIA-N2 NSCLC |
Patients without stage IIIA-N2 NSCLCa |
|||
|---|---|---|---|---|
| Durvalumab (n = 197) | Placebo (n = 90) | Durvalumab (n = 279) | Placebo (n = 147) | |
| TTDM events, n (%) | 51 (25.9) | 39 (43.3) | 80 (28.7) | 59 (40.1) |
| TTDM HR (95% CI) | 0.45 (0.30-0.69) | 0.63 (0.45-0.88) | ||
| Median TTDM (95% CI), months | NR (NE-NE) | 12.6 (8.7-25.9) | 23.2 (17.8-NE) | 14.8 (10.6-NE) |
| ORR, n/N (%)b | 62/185 (33.5) | 13/83 (15.7) | 64/258 (24.8) | 21/130 (16.2) |
| [95% CI]c | [26.8-40.8] | [8.6-25.3] | [19.7-30.5] | [10.3-23.6] |
DCO = 13 February 2017 (DCO for the primary analysis of PFS): median follow-up of 14.5 months (range: 0.2-29.9 months). CI, confidence interval; DCO, data cut-off; HR, hazard ratio; NE, not estimable; NR, not reached; NSCLC, non-small-cell lung cancer; ORR, objective response rate; PFS, progression-free survival; TTDM, time to death or distant metastasis.
a
Patients with all other stages (including stages IIIA-N0/N1 and IIIB).
b
ORR for response-assessable patients includes unconfirmed responses (N; response-assessable population).
c
ORR 95% CIs were calculated using the Clopper–Pearson method.