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. Author manuscript; available in PMC: 2019 Dec 3.
Published in final edited form as: Lancet. 2016 Dec 13;389(10066):255–265. doi: 10.1016/S0140-6736(16)32517-X

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.