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Showed that a PD-1 antibody also beats chemotherapy in the commoner, non-squamous form of lung cancer, and that PD-L1 staining predicts how much.
CheckMate 057 randomised 582 patients with non-squamous non-small-cell lung cancer that had progressed during or after platinum doublet chemotherapy to nivolumab 3 mg/kg every two weeks (292) or docetaxel 75 mg/m2 every three weeks (290).
Median overall survival was 12.2 months (95 percent confidence interval 9.7 to 15.0) with nivolumab against 9.4 months (8.1 to 10.7) with docetaxel (hazard ratio for death 0.73, 96 percent confidence interval 0.59 to 0.89, p=0.002). One-year survival was 51 against 39 percent and 18-month survival 39 against 23 percent. Response was 19 against 12 percent (p=0.02). Median progression-free survival favoured docetaxel (2.3 against 4.2 months), but the one-year progression-free rate favoured nivolumab (19 against 8 percent): the crossing curves are the classic signature of immunotherapy, where a minority does very well and the median hides it. The benefit was greater at higher PD-L1 expression thresholds of 1, 5 and 10 percent, unlike in the squamous population of CheckMate 017.
The FDA approved nivolumab for non-squamous disease later in 2015. In England NICE TA713 (7 July 2021) recommends nivolumab for advanced non-squamous disease after chemotherapy.
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.
582 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Nivolumab | 292 | 12.2 months | 0.73 (0.59 to 0.89) | 0.002 | link |
| Docetaxel | 290 | 9.4 months | ||||
| Progression-free survival | Nivolumab | 292 | 2.3 months | - | - | link |
| Docetaxel | 290 | 4.2 months |
Shares OAK, CheckMate 017, Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263).
Shares Tumour proportion score (TPS), Immune checkpoint, Adenocarcinoma of the lung, Bristol Myers Squibb.
Shares Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), Bristol Myers Squibb, PD-L1.
Shares Immune checkpoint, Adenocarcinoma of the lung, PD-L1, Lung cancer (all types).
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.