FDA Approves First-Line Pembrolizumab Plus Chemo With or Without Bevacizumab for Cervical Cancer

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.

Reference

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