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Previously, the study met the other primary endpoint of progression free survival, showing statistically significant and clinically meaningful improvements compared to chemoradiotherapy alone.
Pembrolizumab (Keytruda; Merck) in combination with chemoradiotherapy met its primary endpoint of overall survival (OS) in individuals who were newly diagnosed with high-risk locally advanced cervical cancer, according to a news release from the company. In the phase 3 KEYNOTE-A18 trial, the safety profile of the drug was also consistent with previous findings, with no new safety signals identified.1
“This is the first phase 3 trial in which an immunotherapy-based regimen has shown a statistically significant and clinically meaningful improvement in [OS] compared to chemoradiotherapy alone,” Gursel Aktan, MD, PhD, vice president of global clinical development at Merck Research Laboratories, said in the press release. “Building on the positive progression-free survival (PFS) findings from this study, these results underscore our commitment to exploring the role of [pembrolizumab] across different types of cancers in earlier stages of disease, where there is a greater potential for better outcomes.”1
The trial, also known as ENGOT-cx11/GOG-3047, is a randomized double-blind phase 3 trial that investigated pembrolizumab in combination with cisplatin and external beam radiotherapy followed by brachytherapy compared with the placebo and concurrent chemoradiotherapy, according to the press release. Patients in the study had high risk stage IB2-IIB lymph node-positive disease and stage III-IVA disease with or without lymph node-positive disease locally advanced cervical cancer. There were 1060 individuals enrolled who had not previously received any definitive surgery, radiation, or systemic therapy. Primary endpoints included PFS and OS, and secondary endpoints included complete response rate, objective response rate, and safety.1
Treatment was randomized with either pembrolizumab 200 mg intravenously on day 1 of each 3-week cycle for 5 cycles followed by 400 mg on day 1 of each 6-week cycle for an additional 15 cycles plus concurrent chemoradiotherapy; or the placebo intravenously every 3 weeks for 5 cycles with cisplatin weekly for 5 cycles and radiotherapy, according to the press release.1
Previously, the study also met the other primary endpoint of PFS, showing statistically significant and clinically meaningful improvements compared with chemoradiotherapy alone. Data will be presented at the European Society for Medical Oncology Congress 2024. The data supported the FDA’s decision to approve the drug in combination with chemoradiotherapy for the treatment of individuals with International Federation of Gynecology and Obstetrics 2014 Stage III-IVA cervical cancer, according to the press release.1,2
“These findings are important for patients and the medical community alike, and reinforce previous data from the KEYNOTE-A18 trial, now showing this regimen has the potential to extend the lives of patients with locally advanced cervical cancer,” Domenica Lorusso, MD, PhD, professor of Obstetrics and Gynecology at Humanitas University, said in the press release.1
Currently, there are 2 other indications for pembrolizumab in the cervical cancer space, including in combination with chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 as determined by an FDA-approved test; and as a single agent for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA test, according to the news release.1
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