Table 2.
Summary of best overall response and ORR based on responses achieved by week 19 and confirmed by week 25 (intent-to-treat population)
| PF-06439535 group (N = 358) | Bevacizumab-EU group (N = 361) | |
|---|---|---|
| Best overall response, n (%) | ||
| Complete response (CR) | 9 (2.5) | 4 (1.1) |
| Partial response (PR) | 153 (42.7) | 157 (43.5) |
| Stable disease | 154 (43.0) | 166 (46.0) |
| Objective progression | 15 (4.2) | 14 (3.9) |
| Indeterminatea | 27 (7.5) | 20 (5.5) |
| ORR (CR + PR), n (%) | 162 (45.3) | 161 (44.6) |
| 95% exact CIb, % | 40.01–50.57 | 39.40–49.89 |
| Treatment comparison (vs bevacizumab-EU group) | ||
| Unstratified ORR risk differencec, % | 0.653 | |
| 95% CI of differencec, % | − 6.608 to 7.908 | |
| Treatment comparison (vs bevacizumab-EU group) | ||
| Unstratified ORR risk ratioc | 1.015 | |
| 95% CI of risk ratioc | 0.863–1.193 | |
| 90% CI of risk ratioc | 0.886–1.163 |
Data cutoff date 8 May 2017. ORR defined as the percentage of patients within each treatment group who achieved complete response or partial response by week 19 of the study in accordance with RECIST version 1.1, which was subsequently confirmed by week 25
Bevacizumab-EU reference bevacizumab sourced from the European Union, CI confidence interval, CR complete response, N number of patients randomized, n number of patients with observation, ORR objective response rate, PR partial response, RECIST Response Evaluation Criteria in Solid Tumors
aIndeterminate: early death, unevaluable tumor assessment, and early study discontinuations
bExact method based on F-distribution was used
cBased on 2-sided Miettinen and Nurminen method without stratification variables