Summary of studies highlighting the role of immunotherapy in treatment of recurrent or metastatic cervical cancer
| Author, year | Type | Sample size | Inclusion criteria | Treatment | Median follow up | Disease response | Toxicity |
|---|---|---|---|---|---|---|---|
| Frenel et al. [33], 2017 | Multicentre, phase 1b, single-arm trial | 46 | Locally advanced, or metastatic PD-L1-positive cervical cancer that had progressed after prior standard therapy | Pembrolizumab every 2 weeks for up to 24 months or until progression, unacceptable toxicity | 11 months | 17% overall response, median OS 11 months, 1-year PFS 4% | 5/24 grade 3 treatment-related AE |
| Chung et al. [34], 2019 | Phase 2 | 98 | Previously treated advanced cervical cancer | Pembrolizumab 200 mg q3 weeks for 2 years or till progression, intolerable toxicity, or physician/patient decision | 10.2 months | ORR 12.2% | Grade 3–4 AE 12.2% |
| Tewari et al. [35], 2021 | Randomised phase 3 | 608 | Recurrent cervical cancer who had progressed on platinum-based therapy | Cemiplimab (350 mg every 3 weeks) or investigator’s choice of chemotherapy in 6-week cycles | 18.2 months | Median OS 12 months (cemiplimab) vs. 8.5 months | Grade > 3 AE in 45% with cemiplimab vs. 53.4% |
| Naumann et al. [39], 2019 | Phase 1/2 | 19 | Recurrent or metastatic cervical carcinoma | Nivolumab monotherapy (240 mg every 2 weeks for ≤ 2 years) until disease progression, unacceptable toxicity | 19.2 months | ORR 26.3% | Any grade AE 12/19 |
| Colombo et al. [40], 2021 | Randomised phase 3 | 584 | Persistent, recurrent, or metastatic cervical cancer | Pembrolizumab (200 mg) or placebo every 3 weeks for up to 35 cycles plus platinum-based chemotherapy and, bevacizumab as per investigator discretion | 22 months | Median PFS 10.4 months (pembrolizumab) vs. 8.2 months2-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
TD: Investigation, Writing—original draft. SA: Conceptualization, Writing—review & editing, Validation, Supervision. Both authors read and approved the submitted version.
The authors declare that they have no conflicts of interest.
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