. Author manuscript; available in PMC: 2023 Dec 5.

Published in final edited form as: Cancer Treat Rev. 2022 Mar 31;106:102385. doi: 10.1016/j.ctrv.2022.102385

Table 3.

Selected therapies under investigation for first-line treatment of recurrent/metastatic cervical cancer.

Therapy	Mechanism of action	Cervical cancer-related health authority designations/decisions	Pivotal trial name/IDs	Study design	Patient population	Treatment arms	Primary endpoint(s)	Primary endpoint completion date	Available pivotal trial efficacy data
Pembrolizumab	Anti-PD-1 antibody	FDA approval October 2021: in combination with chemotherapy in patients with PD-L1 positive tumors (CPS ≥ 1) [58]	KEYNOTE-826 NCT03635567	Phase III, double-blind, randomized 1:1	Adults with r/m or persistent SCC, AC, or ASC cervical cancer not previously treated; known PD-L1 status prior to randomization	Experimental arm: Pembrolizumab 200 mg IV + investigator choice of platinum-based chemotherapy regimen (IC) on day 1 per 21-day cycle Control arm: Placebo + IC on day 1 per 21-day cycle	PFS by ICR per RECIST v1.1 OS	November 2022	Colombo et al. 2021 [32] ITT population (N = 617) Median PFS Pembro arm 10.4 months Placebo arm 8.2 months HR, 0.65; P < 0.001 24-month OS Pembro arm 50.4% Placebo arm 40.4% HR, 0.67; P < 0.001 PD-L1 CPS ≥ 1 (N = 548) Median PFS Pembro arm 10.4 months Placebo arm 8.2 months HR, 0.62; P < 0.001 24-month OS Pembro arm 53% Placebo arm 41.7% HR, 0.64; P < 0.001
Atezolizumab	Anti-PD-L1 antibody	None	BEATcc/ENGOT-cx10 NCT03556839	Phase III, open-label, randomized 1:1	Adults with r/m or persistent SCC, AC, or ASC cervical cancer not previously treated	Experimental arm: atezolizumab 1200 mg + chemotherapy (cisplatin 50 mg/m² or carboplatin AUC 5 + paclitaxel 175 mg/m²) + bevacizumab 15 mg/kg IV on day 1 per 21-day cycle Control arm: chemotherapy + bevacizumab 15 mg/kg IV on day 1 per 21-day cycle	OS	Expected March 2023	None
Prolgolimab (BCD-100)	Anti-PD-1 antibody	None	FERMATA/ENGOT-cx13 NCT03912415	Phase III, double-blind randomized 1:1	Adults with r/m or persistent SCC cervical cancer not previously treated; known PD-L1 status prior to randomization	Experimental arm: prolgolimab 3 mg/kg IV Q3W + chemotherapy (cisplatin or carboplatin + paclitaxel) +/− bevacizumab Control arm: placebo + chemotherapy +/− bevacizumab	OS	Expected December 2024	None

Trial design and anticipated primary endpoint completion dates were obtained from the respective clinicaltrials.gov webpages. Therapies are listed in order of primary endpoint completion date.

AC, adenocarcinoma; ASC, adenosquamous carcinoma; ICR, independent central review; IV, intravenous; OS, overall survival; PD-1, programmed cell death-1; PD-L1, programmed cell death ligand-1; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; SCC, squamous cell carcinoma.