KEYNOTE-407 showed that adding pembrolizumab to chemotherapy helped people with squamous lung cancer live longer whatever their PD-L1 level, and made chemo-immunotherapy the standard first treatment for this type.
KEYNOTE-407 randomised 559 patients with untreated metastatic squamous non-small-cell lung cancer to carboplatin and either paclitaxel or nab-paclitaxel with pembrolizumab or with placebo, followed by pembrolizumab or placebo maintenance. Squamous tumours had been left behind by the targeted-therapy era and had no chemotherapy-free option beyond high-PD-L1 pembrolizumab.
Both primary endpoints, overall survival and progression-free survival, favoured the pembrolizumab arm, and the benefit was seen across PD-L1 expression groups. The combination was approved in the United States in October 2018 and became the first-line standard for squamous disease without a driver mutation.
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.
559 enrolled.
Median follow-up 7.8 months; 559 randomised
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel | - | 15.9 months | 0.64 (0.49 to 0.85) | <0.001 | link |
| Placebo + carboplatin + paclitaxel or nab-paclitaxel | - | 11.3 months | ||||
| Progression-free survivalprimary | Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel | - | 6.4 months | 0.56 (0.45 to 0.7) | <0.001 | link |
| Placebo + carboplatin + paclitaxel or nab-paclitaxel | - | 4.8 months | ||||
| Grade 3 or higher adverse events | Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel | - | 69.8% | - | - | link |
| Placebo + carboplatin + paclitaxel or nab-paclitaxel | - | 68.2% | ||||
| Discontinuation for adverse events | Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel | - | 13.3% | - | - | link |
| Placebo + carboplatin + paclitaxel or nab-paclitaxel | - | 6.4% |
A second publication from the KEYNOTE-407 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 NCT02775435 with the most citations, so it is the natural first reading for anyone following the KEYNOTE-407 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 Carboplatin, Lung cancer (all types), Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares PD-L1-high non-small-cell lung cancer without a driver mutation, Lung cancer (all types), Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Paclitaxel / nab-paclitaxel, Carboplatin and the tag subtype-trials.