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The FDA approved Keytruda for use with chemotherapy with or without bevacizumab, for the treatment of a subset of patients with cervical cancer.
The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer with tumors that express the PD-L1 protein.
The FDA also approved Keytruda as a single agent to treat patients with recurrent or metastatic cervical cancer with disease progression while on or after treatment with chemotherapy and whose tumors express PD-L1, according to an FDA release.
In particular, PD-L is a protein that typically keeps the body’s immune responses under control. When it binds to another protein —PD-1 — found on T cells, it prevents T cells from killing other cells that contain PD-L1, including cancer cells. Keytruda blocks the PD-1 pathway and allows the immune system to detect and kill cancer cells.
This FDA approval was based on findings from the KEYNOTE-826 trial, which assessed Keytruda with chemotherapy in 617 patients with persistent, recurrent or first-line metastatic cervical cancer who did not previously receive chemotherapy. Specifically, patients were randomly assigned either 200 milligrams of Keytruda plus chemotherapy with or without bevacizumab or placebo plus chemotherapy with or without bevacizumab. Patients treated with Keytruda continued treatment until disease progression, unacceptable side effects or 24 months of treatment, whichever occurred first.
The main objectives of this trial were to assess overall survival (OS, percentage of patients who are still alive after treatment initiation) and progression-free survival (PFS, time during and after treatment that a patient lives with cancer without disease worsening). OS was not reached in patients assigned Keytruda (meaning that more than half of patients were alive when this was assessed) compared with 16.3 months in those assigned placebo. Median PFS was 10.4 months in the Keytruda group versus 8.2 months in the placebo group.
In addition, objective response rates (a measurable response to treatment) were 68% in patients assigned Keytruda compared with 50% in those assigned placebo. The median duration of response (the time that a tumor responds to treatment without cancer growth or spread) was 18 months in the Keytruda group versus 10.4 months in the placebo group.
The most common side effects that occurred in at least 20% of patients treated with Keytruda, chemotherapy and bevacizumab in the KEYNOTE-826 trial included hair loss, weakness and numbness to the hands and feet, fatigue/weakness, anemia, neutropenia (low white blood cell counts called neutrophils), nausea, high blood pressure, diarrhea, constipation, low platelet count, vomiting, joint pain, rash, urinary tract infection, underactive thyroid, low level of white blood cells that may affect the ability to fight infection and decreased appetite.
According to the FDA release, the recommended dose of Keytruda is 200 milligrams every three weeks or 400 milligrams every six weeks until disease progression, unacceptable side effects or up to 24 months.
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