The FDA approval is based on the Phase 3 KEYNOTE-826 trial, which showed superior overall survival and progression-free survival
Merck’s Keytruda approved to treat cervical cancer in US. (Credit: Merck KGaA, Darmstadt, Germany.)
Merck has received the US Food and Drug Administration (FDA) approval for its anti-PD-1 therapy Keytruda, in combination with chemotherapy, to treat a type of cervical cancer.
Keytruda plus chemotherapy with or without bevacizumab, is indicated for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1.
The humanised monoclonal antibody therapy works by harnessing the ability of the body’s immune system to help detect and fight tumour cells.
Keytruda has been previously approved for several indications in Melanoma, Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Cancer, Hodgkin Lymphoma, among other diseases.
Merck Research Laboratories global clinical development head and senior vice president Roy Baynes said: “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.
“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 tumors express PD-L1 (CPS ≥1).”
The FDA approval is based on the Phase 3 KEYNOTE-826 trial evaluating Keytruda plus chemotherapy including paclitaxel plus cisplatin or paclitaxel plus carboplatin.
In the study, Keytruda plus chemotherapy, with or without bevacizumab showed superior overall survival and progression-free survival compared to chemotherapy.
Also, large proportion of patients responded to Keytruda combination compared to chemotherapy, with an objective response rate (ORR) of 68%.
Among patients who responded, the median duration of response (DOR) was 18 months for Keytruda combination and 10.4 months for chemotherapy.
The serious adverse reactions include febrile neutropenia, urinary tract infection, anaemia, and acute kidney injury and sepsis.
Cervical cancer occurs in the cells lining the cervix, the lower part of the uterus, and is the fourth most commonly diagnosed cancer in women.