The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) plus chemoradiotherapy for the treatment of patients with stage 3-4A cervical cancer, according to a press release from the agency.
The approval is based off findings from the randomized KEYNOTE-A18 clinical trial, which included 1,060 patients with cervical cancer who did not previously undergo definitive surgery, radiation or systemic therapy — 596 patients had stage 3-4A disease, and 462 patients had stage 1B-2B disease with cancer in the lymph nodes.
KEYNOTE-A18 trial participants were randomly assigned to receive either Keytruda every three weeks for five cycles, as well as chemoradiotherapy, including cisplatin and external beam radiation therapy, followed by brachytherapy or placebo plus chemoradiotherapy, external beam radiation therapy and brachytherapy.
Findings showed that the Keytruda group had superior progression-free survival (time from treatment until disease progression or death) compared to the placebo group, with 21% and 31% of patients with stage 3-4A disease treated with Keytruda or placebo, respectively, experiencing disease progression or death. At the time of the data analysis, overall survival (time from treatment until death of any cause) data were not yet mature, meaning that not enough patients on the study had died for the researchers to calculate an average time until death.
The most common side effects that were observed in 10% or more of patients receiving Keytruda included: nausea, diarrhea, vomiting, urinary tract infection, fatigue, hypothyroidism, constipation, decreased appetite, weight loss, abdominal pain, fever, hyperthyroidism, painful urination, rash and pelvic pain.
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