# Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study

Source: https://onco.cc/key-papers/paper-keynote-158-j-clin-oncol-2019/  
OnCo record `paper-keynote-158-j-clin-oncol-2019` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Published report from the KEYNOTE-158 trial registered as NCT02628067, in Journal of Clinical Oncology (2019), chosen as the most cited paper whose own text cites the registry id.

## Summary

Purpose: KEYNOTE-158 ( ClinicalTrials.gov identifier: NCT02628067) is a phase II basket study investigating the antitumor activity and safety of pembrolizumab in multiple cancer types. We present interim results from patients with previously treated advanced cervical cancer.

Patients and methods: Patients received pembrolizumab 200 mg every 3 weeks for 2 years or until progression, intolerable toxicity, or physician or patient decision. Tumor imaging was performed every 9 weeks for the first 12 months and every 12 weeks thereafter. The primary end point was objective response rate (ORR), assessed per Response Evaluation Criteria in Solid Tumors (version 1.1) by independent central radiologic review. Safety was a secondary end point.

Results: Ninety-eight patients were treated. Median age was 46.0 years (range, 24 to 75 years), and 65.3% of patients had Eastern Cooperative Oncology Group performance status of 1. Eighty-two patients (83.7%) had programmed death-ligand 1 (PD-L1)-positive tumors (combined positive score ≥ 1), 77 having previously received one or more lines of chemotherapy for recurrent or metastatic disease. Median follow-up was 10.2 months (range, 0.6 to 22.7 months). ORR was 12.2% (95% CI, 6.5% to 20.4%), with three complete and nine partial responses. All 12 responses were in patients with PD-L1-positive tumors, for an ORR of 14.6% (95% CI, 7.8% to 24.2%); 14.3% (95% CI, 7.4% to 24.1%) of these responses were in those who had received one or more lines of chemotherapy for recurrent or metastatic disease. Median duration of response was not reached (range, ≥ 3.7 to ≥ 18.6 months). Treatment-related adverse events occurred in 65.3% of patients, and the most common were hypothyroidism (10.2%), decreased appetite (9.2%), and fatigue (9.2%). Treatment-related grade 3 to 4 adverse events occurred in 12.2% of patients.

Conclusion: Pembrolizumab monotherapy demonstrated durable antitumor activity and manageable safety in patients with advanced cervical cancer. On the basis of these results, the US Food and Drug Administration granted accelerated approval of pembrolizumab for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy.

Indexed on Europe PMC as PubMed record 30943124 (DOI 10.1200/jco.18.01265). Its abstract cites the registry id NCT02628067, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Tags: europepmc-ingest
- Journal: Journal of Clinical Oncology
- Year: 2019
- DOI: 10.1200/jco.18.01265
- Authors: Chung HC, Ros W, Delord JP, et al.
- What it means: This is the paper Europe PMC returns for registry id NCT02628067 with the most citations, so it is the natural first reading for anyone following the KEYNOTE-158 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.

## Sources

- J Clin Oncol 2019: https://doi.org/10.1200/jco.18.01265
- PubMed: https://pubmed.ncbi.nlm.nih.gov/30943124/
- Europe PMC: https://europepmc.org/article/MED/30943124
- ClinicalTrials.gov NCT02628067: https://clinicaltrials.gov/study/NCT02628067

## Connected records

- trials: [KEYNOTE-158](https://onco.cc/trials/keynote-158/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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