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. 2021 Jan 28;5(1):11–24. doi: 10.23922/jarc.2020-064

Table 1.

Clinical Outcomes from Pivotal Trials in Patients with dMMR/MSI-H.

KEYNOTE-177 CheckMate 142 KEYNOTE-164 KEYNOTE-016
Treatment line 1st 1st ≥ 2nd ≥ 2nd ≥ 2nd ≥ 3rd ≥ 3rd
Phase III II II II II II
Number of patients 153 154 45 74 119 63 61 10
Regimen Pembro Chemo Nivo + Ipi* Nivo Nivo + Ipi** Pembro Pembro Pembro
ORR 44% 33% 60% 31% 55% 33% 33% 40%
DCR 65% 75% 84% 69% 80% 57% 51% 90%
mPFS (months) 16.5 8.2 NR 14.3 NR 4.1 2.3 NR
12-month PFS rate 55% 37% 77% 50% 71% 41% 78%
(at 20 weeks)
mOS (months) - - NR NR NR NR 31.4 NR
12-month OS rate - - 83% 73% 85% 76% 72% -

Abbreviations: dMMR, deficient mismatch repair; MSI-H, microsatellite instability-high; Pembro, pembrolizumab; Nivo, nivolumab; Ipi, ipilimumab; Chemo, chemotherapy; ORR, overall response rate; DCR, disease control rate; PFS, progression-free survival, OS, overall survival; NR, not reached.

* Nivo 3 mg/kg biweekly + Ipi 1 mg/kg every 6 weeks

** Nivo 3 mg/kg + Ipi 1 mg/kg every 3 weeks (four doses) followed by Nivo 3 mg/kg biweekly