KEYNOTE-775 / Study 309
A pill that blocks tumour blood vessels plus immunotherapy extended survival after chemotherapy, including in tumours that immunotherapy alone does not touch.
OS 18.3 vs 11.4 months in all comers (HR 0.62) and 17.4 vs 12.0 months in pMMR (HR 0.68); PFS 7.2 vs 3.8 months (NEJM 2022). Full approval 2021 for pMMR disease after platinum. Toxicity is substantial: hypertension, hypothyroidism, diarrhoea, and dose reductions in two-thirds of patients. Now largely used after first-line chemo-immunotherapy.
Setting
Advanced endometrial cancer after platinum: lenvatinib + pembrolizumab vs doxorubicin or weekly paclitaxel
Phase
Phase 3
Sponsor
Eisai / Merck
Registry
Headline result
OS 18.3 vs 11.4 months (HR 0.62).
Reported
2021
Enrolled
827
In plain words
What these results mean for people, not percentages
Overall survival (all comers)primarysurvival endpoint
- Median 18.3 vs 11.4 months with Lenvatinib + pembrolizumab compared with Chemotherapy; about 6.9 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 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.51 to 0.75).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Progression-free survival (all comers)primarysurrogate endpoint
- Median 7.2 vs 3.8 months with Lenvatinib + pembrolizumab compared with Chemotherapy; about 3.4 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 44 percent lower chance of the event at any given time (hazard ratio 0.56, likely range 0.47 to 0.66).
- 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.
Be careful
- These results apply to the people the trial enrolled: Advanced endometrial cancer after platinum: lenvatinib + pembrolizumab vs doxorubicin or weekly paclitaxel. 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.