FDA Approves Pembrolizumab Plus Chemoradiotherapy to Treat FIGO 2014 Stage III-IVA Cervical Cancer


The approval was based on the results of a phase 3 trial that found an improvement in progression-free survival among individuals treated with pembrolizumab.

The FDA has approved pembrolizumab (Keytruda; Merck), an anti-programmed death receptor-1 (PD-1) therapy, plus chemoradiotherapy (CRT) to treat individuals with International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage III-IVA cervical cancer.

Female Reproductive System Anatomy - Image credit: mi_viri | stock.adobe.com

Image credit: mi_viri | stock.adobe.com

“Today’s approval of Keytruda plus chemoradiotherapy is welcome news and gives patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer, for the first time ever, the option of an anti-PD-1-based regimen to treat their cancer,” said Bradley Monk, MD, oncologist and professor of obstetrics and gynecology at the University of Arizona’s College of Medicine and Creighton University School of Medicine, in a press release. “This Keytruda-based regimen offers a new treatment option for these patients, so today’s approval has important implications for the way we treat them moving forward.”

Cervical cancer forms in the cells that line the cervix, in the lower area of the uterus. The study authors noted that cervical cancer is the fourth most common cancer among women around the globe. Approximately 13,960 cases of invasive cervical cancer and around 4310 occurred in the United States in 2023.

Pembrolizumab is a 100 mg injection designed to expand the body’s immune system to detect and attack tumor cells.

The study authors noted that pembrolizumab in combination with chemotherapy, with or without bevacizumab, is approved in the United States to treat individuals with recurrent cervical cancer.

The current approval was based on the results of the Phase 3 KEYNOTE-A18 trial— a multicenter, randomized, double-blind, placebo-controlled study, that assessed pembrolizumab connected with CRT among individuals with FIGO 2014 Stage III-IVA disease.

The study included 1060 individuals diagnosed with cervical cancer who were not previously treated with definitive surgery, radiation, or systemic therapy for cervical cancer. The individuals were randomly assigned to receive pembrolizumab plus CRT or a placebo with CRT.

The results found an improvement in progression-free survival (PFS) in individuals that were treated with pembrolizumab, compared to the placebo. The study authors noted that risk of disease progression or death was reduced by 41%. However, medium PFS was not achieved in either group.

Immune-mediated adverse reactions when being treated with pembrolizumab plus CRT included pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation, according to study authors.

The study authors noted that identifying and managing immune-related adverse reactions early on in treatment are essential to guarantee safe use with pembrolizumab.

“Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Gursel Aktan, MD., vice president, global clinical development, Merck Research Laboratories, in a press release. “This approval provides newly diagnosed patients with an anti-PD-1-based treatment option that has the potential to reduce the risk of disease progression or death compared to chemoradiotherapy alone.”


FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer. Merck. News release. January 12, 2024. Accessed January 15, 2024. https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-plus-chemoradiotherapy-as-treatment-for-patients-with-figo-2014-stage-iii-iva-cervical-cancer/.

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