Table 2.
Antitumour activity
| All patients | Patients with combined positive score ≥10 | ||||
|---|---|---|---|---|---|
| Sintilimab and chemotherapy (n=327) | Placebo and chemotherapy (n=332) | Sintilimab and chemotherapy (n=188) | Placebo and chemotherapy (n=193) | ||
| Confirmed objective response (No (%; 95% CI))* | 216 (66; 61 to 71) | 151 (45; 40 to 51) | 127 (68; 61 to 74) | 94 (49; 42 to 56) | |
| Estimated difference (% (95% CI)) | 20 (13 to 28) | 19 (9 to 28) | |||
| P value | <0.001 | <0.001 | |||
| Best overall response (No (%)) | |||||
| Complete response | 6 (2) | 5 (2) | 6 (3) | 4 (2) | |
| Partial response | 210 (64) | 146 (44) | 121 (64) | 90 (47) | |
| Stable disease | 79 (24) | 129 (39) | 50 (27) | 70 (36) | |
| Progressive disease | 11 (3) | 30 (9) | 4 (2) | 18 (9) | |
| Not assessable† | 21 (6) | 22 (7) | 7 (4) | 11 (6) | |
| Confirmed disease control (No (%; 95% CI)) | 295 (90; 87 to 93) | 280 (84; 80 to 89) | 177 (94; 91 to 98) | 164 (85%; 80 to 90) | |
| Duration of confirmed response (months, median (95% CI)) | 9.7 (7.1 to 13.7) | 6.9 (5.6 to 7.2) | 12.4 (7.2 to 15.4) | 5.7 (5.1 to 7.6) | |
| P value | <0.001 | 0.003 | |||
Percentages might not sum to 100 because of rounding.
Chemotherapy regimen is cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil.
*
Confirmed objective response was defined as a response (complete or partial) confirmed by two consecutive tumour assessments according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, assessed by investigators.
†
Imaging assessment was not done at the first tumour assessment (week 6) because treatment was ongoing and time of treatment was less than six weeks, or treatment was discontinued before six weeks after randomisation.