NRG-GY018 / KEYNOTE-868
NRG-GY018 is the pembrolizumab twin of RUBY: immunotherapy plus chemotherapy cut the risk of progression by 70% in dMMR tumours and 46% in the rest.
PFS HR 0.30 in dMMR and 0.54 in pMMR cohorts (NEJM 2023). FDA approval June 2024 for primary advanced or recurrent disease regardless of MMR status. Run by the NRG cooperative group with Merck support.
Setting
Advanced or recurrent endometrial cancer: pembrolizumab + carboplatin-paclitaxel then pembrolizumab maintenance vs chemotherapy, analysed by MMR status
Phase
Phase 3
Sponsor
NRG Oncology / Merck
Registry
Headline result
PFS HR 0.30 (dMMR), 0.54 (pMMR).
Reported
2023
Enrolled
816
In plain words
What these results mean for people, not percentages
Progression-free survival (dMMR)primarysurrogate endpoint
- The treated group had about 70 percent lower chance of the event at any given time (hazard ratio 0.3).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
Progression-free survival (pMMR)primarysurrogate endpoint
- The treated group had about 46 percent lower chance of the event at any given time (hazard ratio 0.54).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
Be careful
- 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.
- These results apply to the people the trial enrolled: Advanced or recurrent endometrial cancer: pembrolizumab + carboplatin-paclitaxel then pembrolizumab maintenance vs chemotherapy, analysed by MMR status. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (MMR); the result should not be assumed for people whose cancer does not have it.
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.
816 participants enrolled.