June 12, 2018
The U.S. Food and Drug Administration (FDA) expanded the approval of an anti-PD-1 therapy for the treatment of patients with recurrent or metastatic cervical cancer.
Keytruda (pembrolizumab, Merck) is now approved for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA approved test.
“Keytruda is now the first anti-PD-1 therapy approved for the treatment of advanced cervical cancer, providing an important new second-line option for certain patients with this disease,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press release (June 12, 2018). “This approval also marks the first indication for Keytruda in a gynecologic cancer and reflects our ongoing commitment to bring forward innovative treatment options across a broad range of cancers, including cancers that disproportionately affect women.”
This approval is based on the KEYNOTE-158 trial, which enrolled a total of 98 patients. Among those patients, 79% had tumors that expressed PD-L1 with a CPS greater than or equal to 1. For the 77 patients whose tumors expressed PD-L1 with a CPS ≥1, the objective response rate was 14.3 percent with a complete response rate of 2.6 percent and partial response rate of 11.7 percent. Among the 11 responding patients, median DOR was not yet reached and 91 percent experienced a duration of response of six months or longer.
The most commonly reported adverse reactions among patients with cervical cancer included fatigue, pain, pyrexia, peripheral edema, musculoskeletal pain, diarrhea/colitis, abdominal pain, nausea, vomiting, constipation, decreased appetite, hemorrhage, UTI, infections, rash, hypothyroidism, headache, and dyspnea.
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