Joy Persaud, pharmaphorum
The FDA has approved Merck’s Keytruda as a first-line therapy for advanced cervical cancer.
Keytruda (pembrolizumab) can be used in combination with chemotherapy, with or without bevacizumab, to treat patients with persistent, recurrent or metastatic cervical cancer where the tumour expresses a certain level of PD-L1.
The protein, Programmed Death-Ligand 1 (PD-L1), is found on the surface of many cells throughout the body. Some cancer cells contain large amounts of PD-L1, which helps them to evade the body’s immune system.
Approval follows a phase 3 KEYNOTE-826 trial that evaluated Keytruda administered intravenously as well as chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, compared to the same chemotherapy regimens, with or without bevacizumab.
In the multi-centre, randomised, double-blind, placebo-controlled trial, 617 patients with persistent, recurrent or first-line metastatic cervical cancer who had not been treated with chemotherapy apart from when used concurrently as a radio-sensitising agent were enrolled.
The approved treatment regime demonstrated superior overall survival (OS; HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (PFS; HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) compared to chemotherapy, with or without bevacizumab, where tumours expressed PD-L1 (CPS ≥1).
Patients who received the Keytruda and chemotherapy combination, with or without bevacizumab, enjoyed 19.8 months of overall survival compared to 16.3 months for the group that received a placebo plus chemotherapy.
Dr Bradley Monk, oncologist and professor of obstetrics at Creighton University School of Medicine, said: “Cervical cancer more commonly affects younger women and certain women of colour in the US and unfortunately, women diagnosed with persistent, recurrent or metastatic cervical cancer often have a low survival rate.
“There have been no first-line approvals for women with persistent, recurrent or metastatic cervical cancer in the past seven years. I am excited for today’s approval of a new combination with Keytruda, which offers a new treatment option for appropriate patients.”
Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said the data showing a 36% reduction in the risk of death “are compelling”.
According to Cancer Research UK, there are around 3,200 new cervical cancer cases in the UK every year with incidence rates for cervical cancer in the UK highest in females aged 30-34 (2016-2018). One-third of patients diagnosed with cervical cancer in the UK receive chemotherapy as part of their primary cancer treatment.