The US Food and Drug Administration (FDA) has approved MSD’s anti-PD-1 therapy KEYTRUDA for use with carboplatin and paclitaxel, followed by KEYTRUDA monotherapy, to treat primary advanced or recurrent endometrial carcinoma in adults.

The development marks the third endometrial carcinoma indication for KEYTRUDA in the US, bringing its total to 40.

The FDA granted approval for this treatment regimen based on results from the randomised, multicentre, double-blind, placebo-controlled Phase III NRG-GY018 (KEYNOTE-868) clinical trial.

The trial demonstrated significant improvements in progression-free survival (PFS) for patients treated with KEYTRUDA plus chemotherapy, compared to those receiving a placebo with chemotherapy.

KEYTRUDA plus carboplatin and paclitaxel followed by KEYTRUDA alone reduced the disease progression or mortality risk by 40% in patients with mismatch repair proficient (pMMR) cancer and by 70% in those with mismatch repair deficient (dMMR) cancer.

For patients with pMMR cancer, the median PFS was 11.1 months compared to 8.5 months in the placebo group.

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KEYTRUDA also has two additional approved indications in the US for endometrial carcinoma, including in combination with LENVIMA (lenvatinib) and as a single agent for certain advanced cases.

Merck Research Laboratories global clinical development vice-president Dr Gursel Aktan stated: “Endometrial cancer is now the most common gynaecological cancer in the US, and deaths from the disease are projected to surpass deaths from ovarian cancer in 2024, underscoring the need for treatment advances for more patients.

“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 monotherapy and in combination with LENVIMA.”

The latest development comes after MSD signed a definitive agreement to acquire all outstanding shares of Eyebiotech (EyeBio) through a subsidiary for $3bn.