Table 1.
PFS-2 by Baseline Tumor Burden
| Staging |
Organ Systems With Lesions |
Symptom Severity Score |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M1a |
M1b |
≤3 |
>3 |
≤Median |
>Median |
|||||||
| Pem/plat/pembro (n = 123) | Pem/plat/placebo (n = 53) | Pem/plat/pembro (n = 285) | Pem/plat/placebo (n = 152) | Pem/plat/pembro (n = 235) | Pem/plat/placebo (n = 118) | Pem/plat/pembro (n = 175) | Pem/plat/placebo (n = 88) | Pem/plat/pembro (n = 170) | Pem/plat/placebo (n = 82) | Pem/plat/pembro (n = 187) | Pem/plat/placebo (n = 97) | |
| Events, % | 58.5 | 81.1 | 71.6 | 88.8 | 58.3 | 83.1 | 80.0 | 92.0 | 64.1 | 84.1 | 71.1 | 89.7 |
| Median, mo | 23.0 | 15.0 | 15.1 | 7.6 | 22.5 | 10.5 | 10.3 | 6.6 | 20.4 | 10.1 | 13.8 | 7.6 |
| Stratified HR (CI 95%) | 0.57 | 0.50 | 0.44 | 0.60 | 0.43 | 0.54 | ||||||
| (0.38–0.86) | (0.40–0.62) | (0.33–0.57) | (0.45–0.80) | (0.31–0.59) | (0.41–0.72) | |||||||
| Estimated rates, % | ||||||||||||
| 12 mo | 76.3 | 60.2 | 57.8 | 33.6 | 77.2 | 49.1 | 45.1 | 29.5 | 71.7 | 47.5 | 55.1 | 33.0 |
| 24 mo | 49.0 | 23.3 | 33.4 | 13.8 | 48.3 | 21.5 | 24.5 | 9.1 | 45.6 | 22.5 | 29.1 | 10.3 |
Note: PFS-2 was defined as the time from randomization to second/subsequent tumor progression on next-line treatment or death from any cause.
CI, confidence interval; HR, hazard ratio; Pem, pemetrexed; Pembro, pembrolizumab; PFS, progression-free survival; Plat, platinum.