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KEYNOTE-042 extended pembrolizumab alone to any lung cancer with at least 1 percent PD-L1, but the survival gain came almost entirely from the tumours with 50 percent or more, so chemotherapy is still added for the rest.
KEYNOTE-042 randomised 1,274 patients with untreated advanced non-small-cell lung cancer, no EGFR or ALK alteration and a PD-L1 tumour proportion score of at least 1 percent to pembrolizumab alone or to platinum-based chemotherapy. It asked whether the KEYNOTE-024 result in PD-L1-high disease extended down to lower expression.
Overall survival favoured pembrolizumab in every prespecified group: median 20.0 versus 12.2 months in tumours with a score of 50 percent or more (hazard ratio 0.69), and 16.7 versus 12.1 months in the whole population with 1 percent or more (hazard ratio 0.81). In the exploratory group with scores of 1 to 49 percent, however, survival was no different (13.4 versus 12.1 months, hazard ratio 0.92).
The FDA widened the first-line monotherapy label to PD-L1 of 1 percent or more in April 2019, but guidelines reserve monotherapy for scores of 50 percent or more and pair pembrolizumab with chemotherapy below that, following KEYNOTE-189 and KEYNOTE-407.
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.
1,274 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, PD-L1 tumour proportion score 50% or moreprimary | Pembrolizumab | 299 | 20 months | 0.69 | - | link |
| Platinum chemotherapy | 300 | 12.2 months | ||||
| Overall survival, PD-L1 tumour proportion score 1% or moreprimary | Pembrolizumab | 637 | 16.7 months | 0.81 | - | link |
| Platinum chemotherapy | 637 | 12.1 months |
A second publication from the KEYNOTE-042 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT02220894 with the most citations, so it is the natural first reading for anyone following the KEYNOTE-042 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares IMpower110, Tumour proportion score (TPS), PD-L1 expression testing (22C3, SP142, SP263), PD-L1-high non-small-cell lung cancer without a driver mutation.
Shares Extended-interval immunotherapy: give checkpoint inhibitors every 8-12 weeks once stable, Randomised trials of stopping immunotherapy after one year versus continuing, Tumour proportion score (TPS), PD-L1-high non-small-cell lung cancer without a driver mutation.
Shares Extended-interval immunotherapy: give checkpoint inhibitors every 8-12 weeks once stable, Randomised trials of stopping immunotherapy after one year versus continuing, Tumour proportion score (TPS), PD-1 / PD-L1 immune checkpoint & T-cell activation.
Shares Confirm ultra-low-dose immunotherapy so it can be afforded where most patients live, Extended-interval immunotherapy: give checkpoint inhibitors every 8-12 weeks once stable, Give immunotherapy in the morning, Randomised trials of stopping immunotherapy after one year versus continuing.
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 Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial, Tumour proportion score (TPS), PD-L1-high non-small-cell lung cancer without a driver mutation, PD-1 / PD-L1 immune checkpoint & T-cell activation.
Shares IMpower110, Confirm ultra-low-dose immunotherapy so it can be afforded where most patients live, Tumour proportion score (TPS), PD-L1-high non-small-cell lung cancer without a driver mutation.
Shares Extended-interval immunotherapy: give checkpoint inhibitors every 8-12 weeks once stable, Give immunotherapy in the morning, Randomised trials of stopping immunotherapy after one year versus continuing, Microbiome transplant as a routine immunotherapy adjunct.