EMPOWER-Cervical 1 / GOG-3016 / ENGOT-cx9
The first immunotherapy to extend life in recurrent cervical cancer, approved in Europe but declined by the FDA.
OS 12.0 vs 8.5 months (HR 0.69; NEJM 2022), regardless of PD-L1 or histology. EU approval 2022; the FDA issued a complete response letter in January 2022 over inspection issues, and the application was not resubmitted. Largely superseded by first-line chemo-immunotherapy.
- Median 12 vs 8.5 months with Cemiplimab compared with Chemotherapy; about 3.5 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 31 percent lower chance of the event at any given time (hazard ratio 0.69, likely range 0.56 to 0.84).
- 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: Recurrent cervical cancer after first-line platinum: cemiplimab vs single-agent chemotherapy. 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.
Pages like this
not linked directly; found by shared links- TrialFianlimab + cemiplimab phase 3 (first-line melanoma)
Shares Cemiplimab, Regeneron, PD-1.
- CancerBasal cell carcinoma
Shares Cemiplimab, Regeneron, Sanofi, PD-1.
- ProductFianlimab
Shares Cemiplimab, Regeneron.
- CancerVulvar cancer
Shares Cemiplimab, Regeneron, PD-1.
- TrialKEYNOTE-826
Shares Cervical cancer, PD-1.
- TermSquamous cell carcinoma
Shares Cemiplimab, Cervical cancer.
- CancerCutaneous squamous cell carcinoma
Shares Cemiplimab, Regeneron, Sanofi, PD-1.
- ProductCadonilimab
Shares Cervical cancer, PD-1.