Table 2.
Objective response rate—per independent radiological review committee (intention-to-treat population)
| MB02, N = 315 | EU-bevacizumab, N = 312 | Total, N = 627 | |
|---|---|---|---|
| Overall response—Week 18, n (%) | |||
| CR | 6 (1.9) | 3 (1.0) | 9 (1.4) |
| PR | 121 (38.4) | 136 (43.6) | 257 (41.0) |
| SD | 54 (17.1) | 53 (17.0) | 107 (17.1) |
| PD | 19 (6.0) | 23 (7.4) | 42 (6.7) |
| Not evaluable | 1 (0.3) | 0 | 1 (0.2) |
| Early discontinuationa | 114 (36.2) | 97 (31.1) | 211 (33.6) |
| Objective response—Week 18b,c | |||
| Responder, n (%) | 127 (40.3) | 139 (44.6) | 266 (42.4) |
| 95% CI | (34.9 to 46.0) | (39.0 to 50.3) | (38.5 to 46.4) |
| Non-responder, n (%) | 188 (59.7) | 173 (55.4) | 361 (57.6) |
| ORR risk ratiod, (%) | 0.910 | ||
| 90% CI | (0.780 to 1.060) | ||
| 95% CI | (0.758 to 1.092) | ||
| ORR risk differenced, (%) | − 4.02 | ||
| 90% CI | (− 10.51 to 2.47) | ||
| 95% CI | (− 11.76 to 3.71) | ||
| Best overall responsec, n (%) | |||
| CR | 6 (1.9) | 3 (1.0) | 9 (1.4) |
| PR | 154 (48.9) | 169 (54.2) | 323 (51.5) |
| SD | 93 (29.5) | 93 (29.8) | 186 (29.7) |
| PD | 10 (3.2) | 11 (3.5) | 21 (3.3) |
| Not evaluable | 3 (1.0) | 0 | 3 (0.5) |
| Early discontinuationa,b | 49 (15.5) | 36 (11.5) | 85 (13.6) |
| BORR risk ratio up to Week 18d,e, (%) | 0.926 | ||
| 90% CI | (0.818 to 1.049) | ||
| 95% CI | (0.799 to 1.075) | ||
| BORR risk difference up to Week 18d,f, (%) | − 4.04 | ||
| 90% CI | (− 10.60 to 2.53) | ||
| 95% CI | (− 11.86 to 3.78) | ||
BORR best overall response rate, CI confidence interval, CR complete response, N number of subjects in the intended set, n number of subjects with data available, ORR objective response rate, PD progressive disease, PR partial response, RECIST Response Evaluation Criteria in Solid Tumors, SD stable disease
aEarly discontinuation included subjects at Week 18 classified as ‘NonCR/NonPD’ and ‘missing’
bIn case of missing evaluation, i.e., in case the subject was withdrawn from study before Week 18, the subject was classified as a non-responder
cObjective response was assigned if a subject displayed either CR or PR per RECIST v1.1
dThe ORR estimate was adjusted for the actual randomization strata sex (male/female), smoking status (smoker/non-smoker), disease diagnosis (newly diagnosed/recurrent disease), and disease stage (Stage IIIB/Stage IV) using the Cochran–Mantel–Haenszel estimate of the risk ratio and corresponding 2-sided 90% CI
eEquivalence margin [0.73–1.36]. Confidence intervals calculated with the Mantel–Haenszel method
fEquivalence margin [−12.0% to 12.0%]. Wald asymptotic CIs are specified