Merck – known as MSD outside the US and Canada – has revealed positive results for its checkpoint inhibitor Keytruda in patients with persistent, recurrent or metastatic cervical cancer.
The phase 3 KEYNOTE-826 trial evaluated Keytruda (pembrolizumab) in combination with platinum-based chemotherapy with or without Roche’s Avastin (bevacizumab) for the first-line treatment of adults with persistent, recurrent or metastatic cervical cancer.
According to an interim analysis conducted by an independent data monitoring committee, Keytruda plus chemotherapy, both with or without Avastin, demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) compared to the same chemotherapy regimens with or without Avastin alone.
Importantly, the OS and PFS benefits were observed in patients regardless of their PD-L1 status, making Keytruda the first anti-PD-1/PD-L1 therapy to do so.
The safety profile of Merck’s drug in the KEYNOTE-826 trial was also found to be consistent with previously reported studies.
The positive results are a win for Merck, given that KEYNOTE-826 is the confirmatory trial for the current accelerated approval of Keytruda as a second-line treatment of patients with recurrent or metastatic cervical cancer, following chemotherapy, whose tumours express PD-L1.
“Women diagnosed with metastatic cervical cancer have a particularly poor prognosis, and there is an urgent need for new treatment options,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
“KEYNOTE-826 is the first study to show positive results for immunotherapy in first-line persistent, recurrent or metastatic cervical cancer, and we look forward to sharing these findings at an upcoming congress and discussing them with regulatory authorities,” he added.
In March, Sanofi and Regeneron revealed positive data for their PD-1 inhibitor Libtayo (cemiplimab) in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic.
The phase 3 study included women with either cervical squamous cell carcinoma or adenocarcinoma, who were randomised to receive Libtayo monotherapy or an investigator’s choice of commonly used chemotherapy.
In comparison to chemotherapy, Libtayo reduced the risk of death by 31% compared to chemotherapy in the total population.
For women with cervical squamous cell carcinoma, Libtayo also reduced the risk of death by 27% compared to chemotherapy, and for adenocarcinoma the risk of death was reduced by 44%.