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KEYNOTE-826

Added nearly ten months of life for women with advanced cervical cancer and made immunotherapy part of first-line treatment.

Final analysis: OS 26.4 vs 16.8 months in all comers (HR 0.63) and 28.6 vs 16.5 months in PD-L1 CPS ≥1 (HR 0.60; JCO 2023). FDA approval October 2021 for CPS ≥1 disease. Bevacizumab was given to ~63% of patients at investigator discretion.

Setting
Persistent, recurrent, or metastatic cervical cancer, first line: pembrolizumab + platinum-paclitaxel ± bevacizumab vs placebo + chemotherapy ± bevacizumab
Phase
Phase 3
Sponsor
Merck
Registry
Headline result
OS 26.4 vs 16.8 months (HR 0.63), all comers.
Reported
2021
Enrolled
617
Replication
BEATcc (atezolizumab + chemotherapy + bevacizumab) and COMPASSION-16 (cadonilimab) reproduced the first-line survival benefit with different antibodies.

Outcomes

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In plain words
What these results mean for people, not percentages
617 people took part
Overall survival (all comers)primarysurvival endpoint
  • Median 26.4 vs 16.8 months with Pembrolizumab + chemo ± bev compared with Placebo + chemo ± bev; about 9.6 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 37 percent lower chance of the event at any given time (hazard ratio 0.63, likely range 0.52 to 0.77).
Overall survival (CPS ≥1)primarysurvival endpoint
  • Median 28.6 vs 16.5 months with Pembrolizumab + chemo ± bev compared with Placebo + chemo ± bev; about 12.1 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 0.49 to 0.74).
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: Persistent, recurrent, or metastatic cervical cancer, first line: pembrolizumab + platinum-paclitaxel ± bevacizumab vs placebo + chemotherapy ± bevacizumab. 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.

617 participants enrolled.

Overall survival (all comers)primary
HR 0.63 (0.52–0.77)
Pembrolizumab + chemo ± bev
26.4 mo
Placebo + chemo ± bev
16.8 mo
Source
Overall survival (CPS ≥1)primary
HR 0.6 (0.49–0.74)
Pembrolizumab + chemo ± bev
28.6 mo
Placebo + chemo ± bev
16.5 mo
Source
EndpointArmnValueHR (95% CI)pSource
Overall survival (all comers)primaryPembrolizumab + chemo ± bev30826.4 months0.63 (0.52–0.77)link
Placebo + chemo ± bev30916.8 months
Overall survival (CPS ≥1)primaryPembrolizumab + chemo ± bev28.6 months0.6 (0.49–0.74)link
Placebo + chemo ± bev16.5 months
Replication
BEATcc (atezolizumab + chemotherapy + bevacizumab) and COMPASSION-16 (cadonilimab) reproduced the first-line survival benefit with different antibodies.

Connected

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