KEYNOTE-042
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.
Overview
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.
- Median 20 vs 12.2 months with Pembrolizumab compared with Platinum chemotherapy; about 7.8 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 31 percent lower chance of the event at any given time (hazard ratio 0.69).
- Median 16.7 vs 12.1 months with Pembrolizumab compared with Platinum chemotherapy; about 4.6 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 19 percent lower chance of the event at any given time (hazard ratio 0.81).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Untreated advanced non-small-cell lung cancer without EGFR or ALK alterations and PD-L1 tumour proportion score of 1 percent or more: pembrolizumab versus platinum doublet chemotherapy. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (EGFR); the result should not be assumed for people whose cancer does not have it.
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 participants 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 |
Similar pages
not linked directly; found by shared links- TrialEMPOWER-Lung 1
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-1 / PD-L1 immune checkpoint & T-cell activation.
- Key paperKEYNOTE-001 (Garon 2015): pembrolizumab in non-small-cell lung cancer and the 50% PD-L1 cut-off
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.
- TrialStudy of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participan
Shares Pemetrexed, Paclitaxel / nab-paclitaxel, Merck & Co. (MSD), Carboplatin.
- TrialA Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-34
Shares Pemetrexed, Paclitaxel / nab-paclitaxel, Merck & Co. (MSD), Carboplatin.
- Key paperKEYNOTE-024: pembrolizumab alone beats chemotherapy in PD-L1-high lung cancer
Shares Tumour proportion score (TPS), PD-L1-high non-small-cell lung cancer without a driver mutation, PD-L1, Merck & Co. (MSD).
- TrialA Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With
Shares Pemetrexed, Paclitaxel / nab-paclitaxel, Merck & Co. (MSD), Carboplatin.
- TrialA Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With
Shares Pemetrexed, Paclitaxel / nab-paclitaxel, Merck & Co. (MSD), Carboplatin.
- Key paperKEYNOTE-010 (Herbst 2016): pembrolizumab versus docetaxel in previously treated PD-L1-positive lung cancer
Shares Tumour proportion score (TPS), PD-L1, Merck & Co. (MSD), PD-1.