Summary of studies highlighting the role of immunotherapy in treatment of recurrent or metastatic cervical cancer

Author, yearTypeSample sizeInclusion criteriaTreatmentMedian follow upDisease responseToxicity
Frenel et al. [33], 2017Multicentre, phase 1b, single-arm trial46Locally advanced, or metastatic PD-L1-positive cervical cancer that had progressed after prior standard therapyPembrolizumab every 2 weeks for up to 24 months or until progression, unacceptable toxicity11 months17% overall response, median OS 11 months, 1-year PFS 4%5/24 grade 3 treatment-related AE
Chung et al. [34], 2019Phase 298Previously treated advanced cervical cancerPembrolizumab 200 mg q3 weeks for 2 years or till progression, intolerable toxicity, or physician/patient decision10.2 monthsORR 12.2%Grade 3–4 AE 12.2%
Tewari et al. [35], 2021Randomised phase 3608Recurrent cervical cancer who had progressed on platinum-based therapyCemiplimab (350 mg every 3 weeks) or investigator’s choice of chemotherapy in 6-week cycles18.2 monthsMedian OS 12 months (cemiplimab) vs. 8.5 monthsGrade > 3 AE in 45% with cemiplimab vs. 53.4%
Naumann et al. [39], 2019Phase 1/219Recurrent or metastatic cervical carcinomaNivolumab monotherapy (240 mg every 2 weeks for ≤ 2 years) until disease progression, unacceptable toxicity19.2 monthsORR 26.3%Any grade AE 12/19
Colombo et al. [40], 2021Randomised phase 3584Persistent, recurrent, or metastatic cervical cancerPembrolizumab (200 mg) or placebo every 3 weeks for up to 35 cycles plus platinum-based chemotherapy and, bevacizumab as per investigator discretion22 monthsMedian PFS 10.4 months (pembrolizumab) vs. 8.2 months
2-year OS: 53% (pembrolizumab) vs. 41.7%		Grade 3–5 anaemia: 30.3% (pembrolizumab) vs. 26.9% and neutropenia (12.4% vs. 9.7%)

ORR: objective response rate; PD-L1: programmed death-ligand 1; PFS: progression-free survival; AE: adverse events