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The first trial to show that a PD-1 antibody beats chemotherapy in lung cancer, and it did so in squamous disease, for which almost nothing had worked.
Squamous non-small-cell lung cancer that has progressed after platinum chemotherapy had almost no options: docetaxel gave a median survival of six months and a miserable toxicity profile. CheckMate 017 randomised 272 such patients to nivolumab 3 mg/kg every two weeks or docetaxel 75 mg/m2 every three weeks, with overall survival as the primary endpoint.
Median overall survival was 9.2 months (95 percent confidence interval 7.3 to 13.3) with nivolumab against 6.0 months (5.1 to 7.3) with docetaxel, a 41 percent reduction in the risk of death (hazard ratio 0.59, 0.44 to 0.79). Response rate and progression-free survival also favoured nivolumab, and the effect held regardless of PD-L1 expression level, which is unusual and specific to the squamous population.
The FDA approved nivolumab for squamous non-small-cell lung cancer in 2015 on this trial. In England NICE TA655 (21 October 2020) recommends nivolumab for advanced squamous disease after chemotherapy. CheckMate 017 and CheckMate 057, published months apart, are the pair that made checkpoint inhibition standard second-line care in lung cancer before it moved to first line.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
272 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Nivolumab | 135 | 9.2 months | 0.59 (0.44 to 0.79) | - | link |
| Docetaxel | 137 | 6 months |
Shares Tumour proportion score (TPS), Immune checkpoint, Squamous cell carcinoma of the lung, Bristol Myers Squibb.
Shares Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), Bristol Myers Squibb, PD-L1.
Shares Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), Squamous cell carcinoma of the lung, PD-L1.
Shares Docetaxel, Bristol Myers Squibb, PD-L1, Nivolumab.
Shares Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), PD-L1, Lung cancer (all types).
Shares Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), PD-L1, PD-1.
Shares Immune checkpoint, Bristol Myers Squibb, Nivolumab, PD-1.
Shares Immune checkpoint, PD-L1, Lung cancer (all types), Cytotoxic chemotherapy.