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. Author manuscript; available in PMC: 2017 Jun 18.
Published in final edited form as: Lancet Oncol. 2016 Jun 4;17(7):943–955. doi: 10.1016/S1470-2045(16)30126-7

Table 5. Response to treatment.

Week 25 Entire study period


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).