KEYNOTE-024 & KEYNOTE-189
The two trials that made immunotherapy, alone or with chemotherapy, the first treatment for most advanced lung cancers.
KEYNOTE-024 (305 patients, TPS ≥50%): 5-year OS 31.9% vs 16.3% with chemotherapy. KEYNOTE-189 (616 patients): 5-year OS 19.4% vs 11.3%. Together with KEYNOTE-407 (squamous) they define first-line care for driver-negative disease and are the control arms every new agent (ivonescimab, ADC combinations) must beat.
Setting
First-line metastatic NSCLC without EGFR/ALK: pembrolizumab alone (PD-L1 TPS ≥50%, KEYNOTE-024) or pembrolizumab + platinum-pemetrexed (any PD-L1, non-squamous, KEYNOTE-189)
Phase
Phase 3
Sponsor
Merck
Registry
Headline result
5-year OS 31.9% vs 16.3% (024); 19.4% vs 11.3% (189).
Reported
2016
Enrolled
921
Replication
Replicated by KEYNOTE-042 (PD-L1 ≥1%), KEYNOTE-407 (squamous), IMpower150, and CheckMate 227/9LA; the most replicated result in lung immunotherapy.
In plain words
What these results mean for people, not percentages
KEYNOTE-024: overall survival at 5 years, PD-L1 ≥50%primarysurvival endpoint
- 31.9 vs 16.3 out of 100 alive at 5 years with Pembrolizumab compared with Chemotherapy; 15.6 more per 100.
- Roughly one extra person helped for every 6 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.48 to 0.81).
KEYNOTE-189: overall survival, non-squamousprimarysurvival endpoint
- Median 22 vs 10.6 months with Pembrolizumab + chemotherapy compared with Placebo + chemotherapy; about 11.4 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 40 percent lower chance of the event at any given time (hazard ratio 0.6, likely range 0.5 to 0.72).
Be careful
- 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: First-line metastatic NSCLC without EGFR/ALK: pembrolizumab alone (PD-L1 TPS ≥50%, KEYNOTE-024) or pembrolizumab + platinum-pemetrexed (any PD-L1, non-squamous, KEYNOTE-189). 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.
921 participants enrolled.
KEYNOTE-024: overall survival at 5 years, PD-L1 ≥50%primary
HR 0.62 (0.48–0.81)
Pembrolizumab31.9 of 100
n = 154
Chemotherapy16.3 of 100
n = 151
KEYNOTE-189: overall survival, non-squamousprimary
HR 0.6 (0.5–0.72)
Pembrolizumab + chemotherapy
22 mo
Placebo + chemotherapy
10.6 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| KEYNOTE-024: overall survival at 5 years, PD-L1 ≥50%primary | Pembrolizumab | 154 | 31.9% | 0.62 (0.48–0.81) | — | link |
| Chemotherapy | 151 | 16.3% | ||||
| KEYNOTE-189: overall survival, non-squamousprimary | Pembrolizumab + chemotherapy | 410 | 22 months | 0.6 (0.5–0.72) | — | link |
| Placebo + chemotherapy | 206 | 10.6 months |
Replication
Replicated by KEYNOTE-042 (PD-L1 ≥1%), KEYNOTE-407 (squamous), IMpower150, and CheckMate 227/9LA; the most replicated result in lung immunotherapy.