Table 2.
Primary Efficacy Analysis (FAS)
| BI 695502 (n = 335) | Bevacizumab RP (n = 328) | |
|---|---|---|
| Best ORR (CR + PR), observed, n (%) Best ORR (CR + PR), adjusted,a % (95% CI) |
181 (54.0) 55.9 (48.2–64.8) |
207 (63.1) 65.3 (56.4–75.6) |
| Ratio of best ORR 90% CI |
0.855 0.770–0.951 |
|
| 95% CIb | 0.754–0.970 | |
| Best response until Week 18, n (%) | ||
| CR | 3 (0.9) | 2 (0.6) |
| PR | 178 (53.1) | 205 (62.5) |
| SD | 96 (28.7) | 91 (27.7) |
| PD | 27 (8.1) | 10 (3.0) |
| Not evaluable | 0 | 1 (0.3) |
| Missing | 31 (9.3) | 19 (5.8) |
CI, confidence interval; CR, complete response; FAS, full analysis set; ORR, overall response rate; PD, progressive disease; PR, partial response; RP, reference product; SD, stable disease.
a
Adjusted for treatment, sex, smoking status, NSCLC stage and (non-)East Asian origin.
b
Additional analysis for EU and primary analysis for Japan.