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The trial that validated PD-L1 staining as a way of choosing who gets immunotherapy, and gave pembrolizumab its first lung cancer approval.
KEYNOTE-010 enrolled 1,034 patients at 202 academic centres in 24 countries between August 2013 and February 2015, randomising them 1:1:1 to pembrolizumab 2 mg/kg (345), pembrolizumab 10 mg/kg (346) or docetaxel 75 mg/m2 (343) every three weeks. Entry required PD-L1 on at least 1 percent of tumour cells, and both survival endpoints were tested in the whole population and again in patients with PD-L1 on 50 percent or more.
By 30 September 2015, 521 patients had died. Median overall survival was 10.4 months with pembrolizumab 2 mg/kg, 12.7 months with 10 mg/kg and 8.5 months with docetaxel; the hazard ratios against docetaxel were 0.71 (95 percent confidence interval 0.58 to 0.88, p=0.0008) and 0.61 (0.49 to 0.75) respectively. The effect was larger in the PD-L1-high subgroup, which is the finding that made PD-L1 selection standard.
The FDA approved pembrolizumab for PD-L1-positive previously treated non-small-cell lung cancer in 2015 and broadened it on this trial. In England NICE TA428 (11 January 2017, updated 12 September 2017) recommends it after at least one chemotherapy, stopped at two years. The two doses performed similarly and the licensed dose became a flat 200 mg.
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.
1,034 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Pembrolizumab 2 mg/kg | 345 | 10.4 months | 0.71 (0.58 to 0.88) | 0.0008 | link |
| Docetaxel | 343 | 8.5 months | ||||
| Overall survival, higher dose | Pembrolizumab 10 mg/kg | 346 | 12.7 months | 0.61 (0.49 to 0.75) | - | link |
| Docetaxel | 343 | 8.5 months |
Shares OAK, CheckMate 017, Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263).
Shares KEYNOTE-024 & KEYNOTE-189, Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), PD-L1-high non-small-cell lung cancer without a driver mutation.
Shares KEYNOTE-024 & KEYNOTE-189, Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), PD-L1-high non-small-cell lung cancer without a driver mutation.
Shares KEYNOTE-024 & KEYNOTE-189, Tumour proportion score (TPS), PD-L1-high non-small-cell lung cancer without a driver mutation, Pembrolizumab.
Shares Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), PD-L1-high non-small-cell lung cancer without a driver mutation, PD-L1.
Shares KEYNOTE-024 & KEYNOTE-189, Tumour proportion score (TPS), PD-L1-high non-small-cell lung cancer without a driver mutation, PD-L1.
Shares KEYNOTE-024 & KEYNOTE-189, Immune checkpoint, PD-L1, Lung cancer (all types).
Shares Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), PD-L1-high non-small-cell lung cancer without a driver mutation, PD-L1.