From:  Immunotherapy in cervical cancer: an innovative approach for better treatment outcomes
 

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