A New Immunotherapy Treatment Option for Advanced Cervical Cancer  

THE FDA APPROVED THE IMMUNE CHECKPOINT INHIBITOR PEMBROLIZUMAB IN COMBINATION AND AS A SINGLE AGENT FOR ADVANCED CERVICAL CANCER  

The U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without the targeted therapeutic bevacizumab (Avastin/Mvasi/Zirabev), as first-line treatment for certain patients with persistent, recurrent, or metastatic cervical cancer.  

The FDA also granted regular approval to pembrolizumab as a single-agent therapeutic for patients with recurrent or metastatic cervical cancer.  

Pembrolizumab had been granted accelerated approval for this indication in June 2018, together with a companion diagnostic test that identifies the presence of the PD-L1 protein on cancer cells. Both the combined and single-agent approvals are for patients whose tumors express PD-L1.  

PD-L1 is an immune checkpoint protein expressed on some cancer cells, which inhibits the function of immune cells, allowing the cancer to remain undetected. Pembrolizumab is an immune checkpoint inhibitor that helps release the “brakes,” allowing immune cells to recognize and kill the cancer cells.  

The clinical trial that led to the approval was a multicenter, randomized, double-blind, placebo-controlled study that enrolled 617 patients with persistent, recurrent, or first-line metastatic cervical cancer who had not previously received chemotherapy. Patients were enrolled in the study regardless of their PD-L1 status and received either pembrolizumab plus chemotherapy with or without bevacizumab, or placebo plus chemotherapy with or without bevacizumab. In both groups, chemotherapy was either paclitaxel and cisplatin or paclitaxel and carboplatin.  

For 548 patients with tumors expressing PD-L1, the median overall survival duration was not reached in the pembrolizumab group and was 16.3 months in the placebo group. The median progression-free survival duration was 10.4 months for patients who received pembrolizumab and 8.2 months for patients who received a placebo. The objective response rate was 68 percent for patients in the pembrolizumab group and 50 percent for patients in the placebo group. The median duration of response was 18 months in the pembrolizumab group and 10.4 months in the placebo group. 

It was estimated that 14,480 women would be diagnosed with cervical cancer in the U.S. in 2021. Most cervical cancer cases could be prevented with HPV vaccination and Pap tests. 

The FDA rendered the decision on October 13, 2021.