KEYNOTE-671
Showed that immunotherapy given both before and after lung cancer surgery lengthens survival.
797 patients. EFS HR 0.58; OS HR 0.72 (36-month OS 71% vs 64%). FDA approval October 2023 for the perioperative regimen. Whether the adjuvant phase adds to neoadjuvant alone is untested head-to-head.
Setting
Resectable stage II-IIIB NSCLC: neoadjuvant pembrolizumab + chemotherapy then adjuvant pembrolizumab vs placebo
Phase
Phase 3
Sponsor
Merck
Registry
Headline result
EFS HR 0.58; OS HR 0.72.
Reported
2023
Enrolled
797
Replication
Consistent with CheckMate 816, AEGEAN, CheckMate 77T, and NEOTORCH; the first perioperative regimen with an OS benefit.
In plain words
What these results mean for people, not percentages
Event-free survivalprimarysurrogate endpoint
- Median 47.2 vs 18.3 months with Pembrolizumab + chemotherapy → pembrolizumab compared with Placebo + chemotherapy → placebo; about 28.9 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 41 percent lower chance of the event at any given time (hazard ratio 0.59, likely range 0.48 to 0.72).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survival at 36 monthsprimarysurvival endpoint
- 71.3 vs 64 out of 100 alive at 36 months with Pembrolizumab arm compared with Placebo arm; 7.3 more per 100.
- Roughly one extra person helped for every 14 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 28 percent lower chance of the event at any given time (hazard ratio 0.72, likely range 0.56 to 0.93).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
- These results apply to the people the trial enrolled: Resectable stage II-IIIB NSCLC: neoadjuvant pembrolizumab + chemotherapy then adjuvant pembrolizumab vs placebo. People in a different situation may not see the same effect.
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.
797 participants enrolled.
Event-free survivalprimary
HR 0.59 (0.48–0.72)
Pembrolizumab + chemotherapy → pembrolizumab
47.2 mo
Placebo + chemotherapy → placebo
18.3 mo
Overall survival at 36 monthsprimary
HR 0.72 (0.56–0.93) · p = 0.005
Pembrolizumab arm71.3 of 100
Placebo arm64 of 100
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survivalprimary | Pembrolizumab + chemotherapy → pembrolizumab | 397 | 47.2 months | 0.59 (0.48–0.72) | — | link |
| Placebo + chemotherapy → placebo | 400 | 18.3 months | ||||
| Overall survival at 36 monthsprimary | Pembrolizumab arm | — | 71.3% | 0.72 (0.56–0.93) | 0.005 | link |
| Placebo arm | — | 64% |
Replication
Consistent with CheckMate 816, AEGEAN, CheckMate 77T, and NEOTORCH; the first perioperative regimen with an OS benefit.