. 2023 Jun 9;11(6):e006624. doi: 10.1136/jitc-2022-006624

Table 3.

Landmark trials and registrational data for ICIs for the treatment of endometrial cancer

Trial info	Patients (n)	Agent(s) investigated	Primary endpoint(s)
			PFS	OS
KEYNOTE-775* (NCT03517449)13 125	697†	Pembrolizumab+lenvatinib	HR versus chemotherapy 0.60 (95% CI 0.50 to 0.72; p<0.0001) Median PFS: 6.6 months (95% CI 5.6 to 7.4)	HR versus chemotherapy 0.68 (95% CI 0.56 to 0.84; p=0.0001) Median OS: 17.4 months (95% CI 14.2 to 19.9)
KEYNOTE-775* (NCT03517449)13 125	697†	Investigator’s choice chemotherapy (paclitaxel or doxorubicin)	Median PFS: 3.8 months (95% CI 3.6 to 5.0)	Median OS: 12 months (95% CI 10.8 to 13.3)
			ORR	DOR
GARNET (NCT02715284)7	71‡	Dostarlimab	42.3% (95% CI 30.6% to 54.6%)§	Median DOR: NR§
			ORR
KEYNOTE-158 (NCT02628067)13	90‡	Pembrolizumab	46% (95% CI 35% to 56%)

*KEYNOTE-775 supported regular approval of pembrolizumab plus lenvatinib. Accelerated approval was based on KEYNOTE-146 (see the pMMR endometrial cancer section).

†Patients with tumors that are pMMR/MSS.

‡Patient with tumors that are dMMR.

§Data supporting original accelerated approval, which was subsequently converted to regular approval.

CI, confidence interval; dMMR, mismatch repair deficiency; DOR, duration of response; HR, hazard ratio; ICI, immune checkpoint inhibitor; MSS, microsatellite stable; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; pMMR, mismatch repair proficient.