Table 5. Response to treatment.
Week 25 | Entire study period | |||
---|---|---|---|---|
|
|
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Nivolumab followed by ipilimumab (n=68) | Ipilimumab followed by nivolumab (n=70) | Nivolumab followed by ipilimumab (n=68) | Ipilimumab followed by nivolumab (n=70) | |
Best overall response | ||||
| ||||
Complete response | ·· | ·· | 8/68 (12%) | 4/70 (6%) |
Partial response | ·· | ·· | 30/68 (44%) | 18/70 (26%) |
Stable disease | ·· | ·· | 2/68 (3%) | 6/70 (9%) |
Progressive disease | ·· | ·· | 15/68 (22%) | 20/70 (29%) |
Unable to determine | ·· | ·· | 13/68 (19%) | 22/70 (31%) |
Overall response, n/N (%; 95% CI) | 28/68 14/70 (41%; 29·4-53·8)* | (20%; 11·4-31·3)* | 38/68 (56%; 43·3-67·0) | 22/70 (31%; 20·9-43·6) |
Median duration of overall response, months (IQR) | ·· | ·· | NR (8·4-19·3) | NR (7·5-17·2) |
| ||||
Overall response by PD-L1 expression, n/N evaluable (%; 95% CI) | ||||
| ||||
PD-L1 <5% | 8/31 (26%; 11·9–44·6) | 3/34 (9%; 1·9-237) | 13/31 (42%; 24·5-60·9) | 6/34 (18%; 6·8-34·5) |
PD-L1 ≥5% | 12/22 (55%; 32·2-75·6) | 4/10 (40%; 12·2-73·8) | 16/22 (73%; 49·8-89·3) | 6/10 (60%; 26·2-87·8) |
Data are n/N (%) unless otherwise indicated. NR=not reached. PD-L1=programmed death ligand 1. The assessment of best overall response disregarded the week 13 tumour assessment. Reasons for patients judged as “unable to determine” include discontinuation, start of a subsequent anticancer therapy, or death before the week 25 assessment; and no evaluable tumour assessment done beyond the week 13 timepoint.
Confirmed with scan at week 33 (or any subsequent scan done ≥4 weeks after the week 25 scan).