Pembrolizumab plus chemoradiotherapy extends PFS in advanced cervical cancer

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The addition of pembrolizumab to concurrent chemoradiotherapy conferred a statistically significant and clinically meaningful increase in PFS among women with newly diagnosed high-risk locally advanced cervical cancer, topline data showed.

The prespecified interim analysis of the phase 3 KEYNOTE-A18 trial also revealed a favorable trend in OS, the other primary endpoint of the trial, although these data remained immature.

Pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, exhibited a safety profile consistent with previous reports, and researchers observed no new safety signals.

“Patients with high-risk locally advanced cervical cancer often have a poor prognosis, with more than half of patients experiencing disease recurrence within 2 years. However, there have been limited new treatment advances for these patients beyond the current standard of care in the last 20 years,” Domenica Lorusso, MD, PhD, the study’s overall principal investigator, lead investigator for European Network for Gynecological Oncological Trial (ENGOT) groups, and associate professor of obstetrics and gynecology at Catholic University of Rome, said in a Merck press release. “These results are very encouraging and support the use of pembrolizumab combined with the current standard of care in locally advanced cervical cancer to help address the need for new treatment options beyond chemoradiotherapy alone.”

The Merck-sponsored trial, also known as ENGOT-cx11/GOG-3047, enrolled 1,060 women with newly diagnosed high-risk (stage IB2 to stage IIB with lymph node-positive disease and stage III to stage IVA with and without lymph node-positive disease) locally advanced cervical cancer. Researchers randomly assigned women to a combination of pembrolizumab and concurrent chemoradiotherapy (external beam radiotherapy plus concurrent chemoradiotherapy with cisplatin, followed by brachytherapy) or placebo and the same concurrent chemoradiotherapy regimen.

PFS and OS served as primary endpoints. Secondary endpoints included complete response rate, objective response rate and safety.

Trial data will be presented at a future medical meeting and submitted to regulators, according to the press release.

Pembrolizumab has been FDA approved for two cervical cancer indications for women with PD-L1 tumor expression indicated by an FDA-approved test. These include in combination with chemotherapy, with or without bevacizumab (Avastin, Genentech), for women with persistent, recurrent or metastatic disease, and as a single agent for women with recurrent or metastatic cervical cancer and disease progression on or after chemotherapy.