KEYNOTE-A18 / ENGOT-cx11 / GOG-3047
Adding immunotherapy to curative chemoradiation for locally advanced cervical cancer improved both control and survival, the first such advance in two decades.
24-month PFS 68% vs 57% (HR 0.70; Lancet 2024). 36-month OS 82.6% vs 74.8% (HR 0.67; Lancet 2024 OS paper). FDA approval January 2024 for FIGO 2014 stage III-IVA disease; the first change to the cisplatin-radiation standard set in 1999.
Setting
Newly diagnosed high-risk locally advanced cervical cancer (FIGO 2014 IB2-IIB node-positive or III-IVA): pembrolizumab + cisplatin chemoradiation + brachytherapy, then pembrolizumab, vs chemoradiation
Phase
Phase 3
Sponsor
Merck
Registry
Headline result
PFS HR 0.70; 36-month OS 82.6% vs 74.8% (HR 0.67).
Reported
2023
Enrolled
1060
Replication
CALLA (durvalumab + chemoradiation) was negative, so the benefit is not yet reproduced with another agent; differences in risk population and drug are debated.
In plain words
What these results mean for people, not percentages
Progression-free survival at 24 monthsprimarysurrogate endpoint
- 68 vs 57 out of 100 alive without the cancer growing at 24 months with Pembrolizumab + CRT compared with Placebo + CRT; 11 more per 100.
- Roughly one extra person helped for every 9 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 30 percent lower chance of the event at any given time (hazard ratio 0.7, likely range 0.55 to 0.89).
- 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
- 82.6 vs 74.8 out of 100 alive at 36 months with Pembrolizumab + CRT compared with Placebo + CRT; 7.8 more per 100.
- Roughly one extra person helped for every 13 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 33 percent lower chance of the event at any given time (hazard ratio 0.67, likely range 0.5 to 0.9).
- 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: Newly diagnosed high-risk locally advanced cervical cancer (FIGO 2014 IB2-IIB node-positive or III-IVA): pembrolizumab + cisplatin chemoradiation + brachytherapy, then pembrolizumab, vs chemoradiation. 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.
1,060 participants enrolled.
Progression-free survival at 24 monthsprimary
HR 0.7 (0.55–0.89)
Pembrolizumab + CRT68 of 100
n = 529
Placebo + CRT57 of 100
n = 531
Overall survival at 36 monthsprimary
HR 0.67 (0.5–0.9)
Pembrolizumab + CRT82.6 of 100
Placebo + CRT74.8 of 100
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at 24 monthsprimary | Pembrolizumab + CRT | 529 | 68% | 0.7 (0.55–0.89) | — | link |
| Placebo + CRT | 531 | 57% | ||||
| Overall survival at 36 monthsprimary | Pembrolizumab + CRT | — | 82.6% | 0.67 (0.5–0.9) | — | link |
| Placebo + CRT | — | 74.8% |
Replication
CALLA (durvalumab + chemoradiation) was negative, so the benefit is not yet reproduced with another agent; differences in risk population and drug are debated.