Merck’s Keytruda regimen granted FDA approval to treat endometrial cancer

18 Jun 2024
pmlive.com
Clinical ResultDrug ApprovalVaccine
Merck’s Keytruda regimen granted FDA approval to treat endometrial cancer
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Source: PMLiVE
Merck & Co – known as MSD outside the US and Canada – has received expanded approval from the US Food and Drug Administration (FDA) for the use of Keytruda in endometrial cancer.
The anti-PD-1 therapy can now be used in combination with carboplatin and paclitaxel, and then as a single agent, to treat adults with primary advanced or recurrent endometrial carcinoma.
Approximately 67,880 new cases of uterine cancer will be diagnosed in the US this year and endometrial carcinoma is the most common type.
Administered as an intravenous infusion, Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumour cells.
The therapy already holds a range of approvals in the US, including for two other endometrial carcinoma indications as a monotherapy and in combination with Eisai’s Lenvima (lenvatinib).
The FDA’s latest decision was supported by positive results from the late-stage KEYNOTE-868 trial, in which the Keytruda regimen reduced the risk of disease progression or death by 40% in patients whose cancer was mismatch repair proficient (pMMR) and by 70% in those with mismatch repair deficient (dMMR) disease, compared to placebo plus carboplatin and paclitaxel followed by placebo alone.
For patients whose cancer was pMMR, median progression-free survival (PFS) in the Keytruda regimen group was 11.1 months versus 8.5 months for the placebo plus carboplatin and paclitaxel arm. For those with dMMR disease, median PFS was not reached in the Keytruda group versus 6.5 months for the placebo.
Dr Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, said: “This approval represents the first and only anti-PD-1-based option for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status, building on the established role of Keytruda in certain types of advanced endometrial carcinoma as [a] monotherapy and in combination with Lenvima.”
Beyond endometrial carcinoma, Keytruda holds approvals to treat a wide range of cancers, including specific cases of cervical cancer, bladder cancer, biliary tract cancer, non-small cell lung cancer and renal cell carcinoma.
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