Table 4.
Efficacy results as per local investigator assessment (full analysis set)
| All patients, n (%) | N = 3,246 |
|---|---|
| Best overall response | |
| CR | 99 (3.0) |
| PR | 851 (26.2) |
| Non-CR/Non-PDa | 952 (29.3) |
| SD | 813 (25.0) |
| PD | 178 (5.5) |
| Unknown | 353 (10.9) |
| ORR: CR + PR [95% CI] | 950 (29.3) [27.7–30.9] |
| CBR: CR + PR + (SD + non-CR/non-PD ≥ 24 weeks) [95% CI] | 2,294 (70.7) [69.1–72.2] |
| All patients, months (95% CI) | |
| Median PFS | 26.7 (24.8–30.1) |
| Patients with measurable disease at baseline, n (%) | 2,079 (64.0) |
| Best overall responseb | |
| CR | 56 (2.7) |
| PR | 851 (40.9) |
| SD | 810 (39.0) |
| PD | 134 (6.4) |
| Unknown | 228 (11.0) |
| ORR: CR + PR [95% CI]b | 907 (43.6) [41.5–45.8] |
| CBR: CR + PR + (SD + non-CR/non-PD ≥ 24 weeks) [95% CI]a,b | 1,437 (69.1) [67.1–71.1] |
Response classifications are defined in Online Resource 2
CBR clinical benefit rate, CI confidence interval, CR complete response, ORR overall response rate, PD progressive disease, PFS progression‑free survival, PR partial response, SD stable disease
aUsed instead of “Unknown” wherever possible (i.e., in situations where, based on available information, expert judgment could be used to identify equivocal progression [i.e., PD] or definitively rule this out)
bPercentages are based on population of patients with measurable disease at baseline