FDA Approves Keytruda in Combination with Chemo-radiotherapy for Cervical Cancer

The FDA has approved Keytruda with chemoradiotherapy for treating cervical cancer, based on the KEYNOTE-A18 trial. This marks the first approval of an anti-PD-1 therapy in this combination, showing significant improvement in progression-free survival.

Merck has announced that the US Food and Drug Administration (FDA) approved Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with chemoradiotherapy (CRT), for treating FIGO 2014 Stage III-IVA cervical cancer. Keytruda reduces the risk of disease progression or death by 41% compared to placebo plus CRT. This advancement represents a significant leap in cervical cancer therapy, marking the third FDA approval for Keytruda in cervical cancer and its 39th indication in the US.

Dr. Bradley Monk, an oncologist and professor of obstetrics and gynecology, stated, “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.”

This approval was based on the findings of the KEYNOTE-A18 trial, a robust, multicenter, randomized, double-blind, placebo-controlled study. It enrolled 1060 patients who had not undergone any prior definitive surgery, radiation, or systemic therapy for their cervical cancer. The study showed a notable improvement in progression-free survival (PFS) among patients, particularly those with Stage III-IVA disease, when treated with pembrolizumab in conjunction with CRT.

“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.” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.

In the KEYNOTE-A18 trial, patients were either given pembrolizumab or a placebo, along with CRT. The pembrolizumab regimen included a dose of 200 mg every three weeks for five cycles, followed by a dose of 400 mg every six weeks for 15 cycles. The CRT regimen consisted of cisplatin and external beam radiation therapy (EBRT), supplemented by brachytherapy.

The results were quite promising, showing a significant improvement in progression-free survival (PFS) among the overall population, with a remarkable 41% reduction in the risk of disease progression or death. This benefit was particularly pronounced in patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA disease, compared to those with Stage IB2-IIB disease.

However, it’s crucial to note that, while this treatment option opens new avenues for patients, it also comes with its share of risks. The common adverse reactions observed in the trial included nausea, diarrhea, vomiting, and urinary tract infections, among others. More severe and potentially fatal immune-mediated adverse reactions were also reported. Therefore, it's vital for healthcare providers to monitor patients closely and manage any adverse reactions effectively.