In women whose cervical cancer had grown after chemotherapy, pembrolizumab on its own shrank the tumour in about 1 in every 7 patients whose tumour was PD-L1 positive, and these responses often lasted a long time.
Recurrent or metastatic disease with progression on or after chemotherapy, PD-L1 CPS ≥1; patients not previously treated with immunotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Pembrolizumab | 200 mg every 3 weeks or 400 mg every 6 weeks (30-minute infusion) | IV | Day 1 |
Grade 3–4 treatment-related adverse events occurred in 12.2%. Monitor for and manage immune-mediated adverse events as with other pembrolizumab regimens.
On the page “Cervical cancer” · Metastatic or recurrent disease: second line and beyond
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Pembrolizumab 200 mg IV on day 1 of each 3-week cycle, for up to 35 cycles (about 2 years) or until progression, unacceptable toxicity, or physician or patient decision. Imaging every 9 weeks for the first 12 months, then every 12 weeks.
Source of the regimen details: Abstract of the paper and ClinicalTrials.gov NCT02628067 (day 1 every 3 weeks, up to 35 cycles)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with previously treated advanced cervical cancer; 83.7% had PD-L1-positive tumours (CPS ≥1).
Median age 46 years; 65.3% ECOG 1; 77 of the 82 PD-L1-positive patients had previously received one or more lines of chemotherapy for recurrent or metastatic disease. Patients with autoimmune disease or conditions requiring immunosuppression were excluded (FDA label for pembrolizumab).
Primary endpoint: objective response rate (RECIST 1.1, independent central review). Secondary endpoint: safety.
Treatment-related adverse events in 65.3%; most common: hypothyroidism (10.2%), decreased appetite (9.2%) and fatigue (9.2%). Treatment-related grade 3 to 4 adverse events in 12.2%.
Basis of the FDA accelerated approval of pembrolizumab for PD-L1-positive cervical cancer after chemotherapy; the NCCN guideline lists pembrolizumab as preferred in the second line and beyond for PD-L1-positive, MSI-H/dMMR or TMB-H tumours.
Single-arm, no comparator group; interim report with short follow-up.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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