Updated data support the use of pembrolizumab in combination with chemotherapy as first-line standard care for patients with persistent, recurrent, or metastatic cervical cancer, according to a presentation at the ASCO Annual Meeting 2023.
Researchers found that first-line pembrolizumab plus chemotherapy, with or without bevacizumab, improved progression-free and overall survival when compared with chemotherapy alone.
The findings come from the phase 3 KEYNOTE-826 trial (ClinicalTrials.gov Identifier: NCT03635567), which enrolled 617 patients with persistent, recurrent, or metastatic cervical cancer who had not received prior systemic chemotherapy and were not amenable to curative surgery or radiation.
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The patients were randomly assigned to receive pembrolizumab (n=308) or placebo (n=309) every 3 weeks for up to 35 cycles, in addition to chemotherapy (paclitaxel plus cisplatin or carboplatin). Bevacizumab was also administered to 63.6% of patients in the pembrolizumab arm and 62.5% of patients in the placebo arm.
The median follow-up was 39.1 months. The median overall survival was 26.4 months in the pembrolizumab arm and 16.8 months in the placebo arm (hazard ratio [HR], 0.63; 95% CI, 0.52-0.77; P <.0001).
The median progression-free survival was 10.4 months in the pembrolizumab arm and 8.2 months in the placebo arm (HR, 0.61; 95% CI, 0.50-0.74; P <.0001).
The objective response rate was 66.2% in the pembrolizumab arm and 51.5% in the placebo arm. The median duration of response was 18.0 months and 10.4 months, respectively.
In subgroup analyses, the benefits of pembrolizumab were seen in patients with a PD-L1 combined positive score (CPS) greater than or equal to 1 and in those with a CPS greater than or equal to 10. Benefits were seen with or without the addition of bevacizumab.
In both study arms, anemia, neutropenia, and hypertension were the most common grade 3 or higher adverse events (AEs). Grade 3 or higher treatment-related AEs occurred in 69.1% of patients in the pembrolizumab arm and 65.0% of those in the placebo arm. Treatment-related AEs led to death in 2 patients (0.7%) in the pembrolizumab arm and 4 patients (1.3%) in the placebo arm.
“This is consistent with data you’ve seen before, but I hope it adds confidence to the first-line use of pembrolizumab,” said study presenter Bradley J. Monk, MD, of the University of Arizona College of Medicine – Phoenix.
Dr Monk said these data support first-line pembrolizumab plus chemotherapy, with or without bevacizumab, as standard care for patients with persistent, recurrent, or metastatic cervical cancer.
Disclosures: This research was supported by Merck & Co, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Monk BJ, Colombo N, Tewari KS, et al. KEYNOTE-826: Final overall survival results from a randomized, double-blind, phase 3 study of pembrolizumab + chemotherapy vs placebo + chemotherapy for first-line treatment of persistent, recurrent, or metastatic cervical cancer. ASCO 2023. June 2-6, 2023. Abstract 5500.
