The FDA has approved the use of pembrolizumab plus chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer who have PD-L1 expression identified via an FDA-approved test.
Pembrolizumab (Keytruda) plus chemotherapy with or without bevacizumab (Avastin) has been approved by the FDA as a treatment for patients with persistent, recurrent, or metastatic cervical cancer who have PD-L1 expression identified via an FDA-approved test.
Additionally, the FDA granted approval to single agent pembrolizumab for those with recurrent or metastatic, PD-L1–positive cervical cancer who experienced progression on or following chemotherapy.
In the phase 3 randomized, double-blind, placebo-controlled KEYNOTE-826 trial (NCT03635567), investigators assessed the use of pembrolizumab, paclitaxel and cisplatin or carboplatin, with or without bevacizumab in patients with first-line metastatic persistent recurrent cervical cancer who had not received treatment with chemotherapy. Findings from the study indicated that the therapy resulted in a median overall survival that was not reached (95% CI, 19.8–not reached) compared with 16.3 months in the placebo arm (95% CI, 14.5-19.4; HR, 0.64; 95% CI, 0.50-0.81; 1-sided P-value = .0001).
Additionally, the experimental regimen yielded a median progression-free survival of 10.4 months (95% CI, 9.7-12.3) vs 8.2 months in the placebo cohort (95% CI, 6.3-8.5); HR, 0.62; 95% CI, 0.50-0.77; 1-sided P-value <.0001). The overall response rates for the pembrolizumab and placebo regimens were 68% (95% CI, 62%-74%) and 50% (95% CI, 44%-56%) in both arms, respectively, with a median duration of response of 18.0 months and 10.4 months in each respective group.
Currently, pembrolizumab is recommended at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks until the occurrence of disease progression, unacceptable toxicity, or up to a period of 24 months.
The most common adverse effects associated with the regimen occurring in more than 20% of patients included peripheral neuropathy, alopecia, anemia, fatigue/asthenia, nausea, neutropenia, diarrhea, hypertension and, thrombocytopenia.
The FDA granted an accelerated approval to the companion diagnostic PD-L1 IHC 22C3 pharmDx for this indication in June 2018.
FDA approves pembrolizumab combination for the first-line treatment of cervical cancer. News release. FDA. October 13, 2021. Accessed October 13, 2021. https://bit.ly/3DFNexJ