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. 2021 Sep 29;10(19):4523. doi: 10.3390/jcm10194523

Table 1.

Reported trials of ICI single agent therapy in advanced cervical cancer.

Trial No. of Subjects Included Subjects Intervention ORR (%) mDOR (Months) Survival (Months)
EMPOWER-CERVICAL 1/GOG-3016/ENGOT-CX9 [15] 608 PDL1 unselected
≥1 prior line of therapy
Cemiplimab 350 mg 3 weekly
vs.
Investigator choice chemotherapy
16.4 vs. 6.3 16.4 vs. 6.9 mPFS: 2.8 vs. 2.9 (HR = 0.75 [0.63–0.89])
mOS: 12.0 vs. 8.5 (HR = 0.69 [0.56–0.84])
KEYNOTE-028 [16] 24 PD-L1 ≥ 1% (modified proportion score)
PD on prior therapy
Pembrolizumab 10 mg/kg, 2 weekly 17 5.4 m mPFS 2
mOS 11
KEYNOTE-158 [17] 98 PDL1 unselected
PD on prior therapy
Pembrolizumab 200 mg 3 weekly 12.2 (PDL1 unselected)
14.6 (PDL1 CPS ≥ 1)
NR mPFS 2.1
mOS 9.4 (ITT)
CHECKMATE-358 [18] cervical cohort 19 ≤2 prior lines of therapy
Excluded HPV negative
Nivolumab 240 mg 2 weekly 26.3 NR mPFS 5.1
mOS 21.9
NRG-GY002 [19] 25 PDL1 unselected
PD on prior therapy
Nivolumab 3 mg/kg 2 weekly 4 3.8 mPFS 3.5
mOS 14.5
Lheureux et al. [20] 42 PDL1 unselected Ipilimumab 10 mg/kg 3 weekly (4 cycles) → 12 weekly maintenance (to 1 year) 3 - mPFS 2.5
mOS8.5

mDOR, median duration of response; ORR, objective response rate; HR, hazard ratio; mOS, median overall survival; mPFS, median progression free survival; PD, progressive disease; m, months; NR, not reached.