MSD’s PD-1 inhibitor Keytruda (pembrolizumab) has received approval from the US Food and Drug Administration (FDA) for the first-line treatment of certain cervical cancer patients.
The FDA has cleared Keytruda in combination with chemotherapy – with or without bevacizumab – for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1.
In the Phase III KEYNOTE-826 trial in this patient population, Keytruda plus chemotherapy – with or without bevacizumab – demonstrated both superior overall survival (OS) and progression-free survival (PFS) compared to chemotherapy in PD-L1-positive patients.
On top of that, more patients responded to Keytruda plus chemotherapy compared to chemotherapy alone, with an objective response rate (ORR) of 68% versus 50%.
Among responding patients, the median duration of response (DoR) was 18.0 months for Keytruda plus chemotherapy versus 10.4 months for chemotherapy.
“Today’s news is a meaningful step forward, as it offers a new therapeutic option for these patients and reinforces the role of Keytruda in treating certain types of cervical cancers, with a second indication for the disease,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
“The data showing a 36% reduction in the risk of death are compelling, and this approval brings an important new first-line treatment option to women with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥1),” he added.
The FDA also converted the accelerated approval for Keytruda as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression, whose tumours express PD-L1 to a regular approval, based on the confirmatory KEYNOTE-826 data.