FDA Approves KEYTRUDA for Advanced Endometrial Cancer

The US Food and Drug Administration (FDA) has granted approval to MSD for their anti-PD-1 therapy, KEYTRUDA, to be used in conjunction with carboplatin and paclitaxel, followed by KEYTRUDA monotherapy, for the treatment of primary advanced or recurrent endometrial carcinoma in adults. This marks KEYTRUDA's third approved indication for endometrial carcinoma in the United States, expanding its total approved indications to 40.

The FDA's approval is based on the findings from the Phase III NRG-GY018 (KEYNOTE-868) clinical trial, a randomized, multicenter, double-blind, placebo-controlled study. The trial's results showed significant improvements in progression-free survival (PFS) for patients who were treated with the combination of KEYTRUDA and chemotherapy, compared to those who received a placebo with chemotherapy.

Specifically, the combination therapy of KEYTRUDA with carboplatin and paclitaxel, followed by KEYTRUDA alone, was found to reduce the risk of disease progression or mortality by 40% in patients with proficient mismatch repair (pMMR) cancer and by 70% in those with deficient mismatch repair (dMMR) cancer. For patients with pMMR cancer, the median PFS was 11.1 months, compared to 8.5 months for those in the placebo group.

In addition to this new indication, KEYTRUDA is already approved in the US for two other uses in endometrial carcinoma: in combination with LENVIMA (lenvatinib) and as a monotherapy for certain advanced cases.

Dr. Gursel Aktan, Vice President of Global Clinical Development at Merck Research Laboratories, commented on the significance of this approval. He noted that endometrial cancer has become the most prevalent gynecological cancer in the US, with mortality rates expected to exceed those of ovarian cancer by 2024. This highlights the urgent need for new treatment advancements. Dr. Aktan emphasized that this approval is particularly noteworthy as it represents the first and only anti-PD-1-based treatment option for adult patients with primary advanced or recurrent endometrial carcinoma, regardless of their mismatch repair status. This builds on the established role of KEYTRUDA in treating certain types of advanced endometrial carcinoma, both as a monotherapy and in combination with LENVIMA.

This approval follows MSD's recent agreement to acquire all outstanding shares of Eyebiotech (EyeBio) through a subsidiary, in a deal valued at $3 billion.