Table 2: Summary of key efficacy results.
| Atezolizumab (n=425) | Docetaxel (n=425) | HR (95% CI) | p value | |
|---|---|---|---|---|
| Progression-free survival (ITT population) | ||||
| Patients with event (%) | 380 (89%) | 375 (88%) | 0·95 (0·82–1·10) | 0·49 |
| Median (months; 95% CI) | 2·8 (2·6–3·0) | 4·0 (3·3–4·2) | .. | .. |
| Objective response rate (ITT population) | ||||
| Objective response (%) | 58 (14%) | 57 (13%) | .. | .. |
| Complete response (%) | 6 (1%) | 1 (<1%) | .. | .. |
| Partial response (%) | 52 (12%) | 56 (13%) | .. | .. |
| Stable disease (%) | 150 (35%) | 177 (42%) | .. | .. |
| Progressive disease (%) | 187 (44%) | 117 (28%) | .. | .. |
| Missing or unevaluable (%) | 30 (7%) | 74 (17%) | .. | .. |
| Duration of response (ITT population)* | ||||
| Median (months; 95% CI) | 16·3 (10·0–NE) | 6·2 (4·9–7·6) | 0–34 (0·21–0·55) | <0·0001 |
| Progression-free survival (TC1/2/3 or IC1/2/3) | ||||
| Patients with event (%) | 216/241 (90%) | 193/222 (87%) | 0–91 (0·74–1·12) | 0·38 |
| Median (months; 95% CI) | 2·8 (2·6–4·0) | 4·1 (2·9–4·3) | .. | .. |
| Objective response (TC1/2/3 or IC1/2/3) | ||||
| Objective response | 43/241 (18%) | 36/222 (16%) | .. | .. |
| Complete response | 5/241 (2%) | 1/222 (<1%) | .. | .. |
| Partial response | 38/241 (16%) | 35/222 (16%) | .. | .. |
| Stable disease | 79/241 (33%) | 85/222 (38%) | .. | .. |
| Progressive disease | 102/241 (42%) | 59/222 (27%) | .. | .. |
| Missing or unevaluable | 17/241 (7%) | 42/222 (19%) | .. | .. |
| Duration of response (TC1/2/3 orIC1/2/3)† | ||||
| Median (months; 95% CI) | 16–0 (9·7–NE) | 6·2 (4·9–9·2) | 0·38 (0·22–0·65) | 0·0003 |
HR was stratified for progression-free survival in the ITT and TC1/2/3 or IC1/2/3 populations; unstratified for other subgroups and duration of response.
*
n=58 for the atezolizumab group and n=57 for the docetaxel group.
†
n=43 for the atezolizumab group and n=36 for the docetaxel group. HR=hazard ratio. IC=tumour infiltrating immune cells. ITT=intention-to-treat. NE=not evaluable. TC=tumour cell.