In a Phase III trial, significant improvements in progression-free survival for patients treated with KEYTRUDA plus chemotherapy were observed. Credit: Nemes Laszlo / Shutterstock.
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.
For patients with pMMR cancer, the median PFS was 11.1 months compared to 8.5 months in the placebo group.
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.
The latest development comes after MSD signed a definitive agreement to acquire all outstanding shares of Eyebiotech (EyeBio) through a subsidiary for $3bn.
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