From:  Predictive biomarkers for immunotherapy response in endometrial cancer: current insights and future directions

 Study designs and outcomes of key clinical trials of immunotherapy in a/rEC after failure of platinum-based chemotherapy.

TrialPhasePopulationN ptsTreatment ArmsRPrimary EndpointsmFUOutcomes
KEYNOTE-158 NCT02628067 [14]IIdMMR a/rEC (cohorts D and K)90Pembrolizumab (P) monotherapyNAORR42.6 mORR 48%; DOR NR; PFS 13.1 m; OS NR
GARNET NCT02715284 [25]Ia/rEC (cohorts A1 dMMR and A2 MMRp)153 dMMR
161 MMRp
Dostarlimab (Do) monotherapyNAORR, DOR 27.6 mORR dMMR 45.5%; MMRp 15.4%
DOR dMMR NR; MMRp 19.4 m
ORR by CPS ≥ 1: dMMR 54.9%; MMRp 21.7%
ORR by MTB: dMMR 47.8%; MMRp 45.5%
KEYNOTE-775 NCT03517449 [23]IIIa/rEC 827Lenvatinib + Pembrolizumab (L + P) vs. CTX1:1PFS, OS in dMMR and ITT    12.2 m (L + P); 10.7 m (CTX) PFS MMRp: L + P 6.6 m vs. CTX 3.8 m; HR 0.60; p < 0.001
PFS ITT: L + P 7.2 m vs. CTX 3.8 m; HR 0.56; p < 0.001
OS MMRp: L + P 17.4 vs. CTX 12.0 m; HR 0.68; p < 0.001
OS ITT: L + P 18.3 m (15.2–20.5) vs. CTX 11.4 m; HR 0.62; p < 0.001

a/rEC: advanced and recurrent endometrial cancer; CPS: combined positive score; CTX: chemotherapy (platinum plus paclitaxel); dMMR: defective mismatch repair; DOR: duration of response; HR: hazard ratio; ITT: intention-to-treat; mFU: median follow-up; MMRp: proficient mismatch repair; MTB: mutational tumor burden; NA: not applicable; NR: not reached; ORR: objective response rate; OS: overall survival; PFS: progression-free survival; R: randomization.