FDA Approval of Keytruda Sparks Endometrial Cancer Battle

Merck & Co.’s Keytruda (pembrolizumab) has achieved a groundbreaking milestone by becoming the first anti-PD-1 therapy approved by the FDA for use in combination with chemotherapy in adults with primary advanced or recurrent endometrial carcinoma, irrespective of their mismatch repair status. This approval marks Keytruda's third indication for endometrial cancer and its 40th overall in the United States.

The FDA's decision closely follows its recent approval of AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) combined with chemotherapy for treating adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). Additionally, GSK’s PD-1-blocking antibody Jemperli (dostarlimab) has received US approval for first-line treatment of advanced or recurrent dMMR endometrial cancer. A decision is anticipated by August 23 on whether Jemperli’s use will be expanded to include all adults with primary advanced or recurrent endometrial cancer.

Keytruda’s latest approval stems from the positive results of the Phase III KEYNOTE-868 study. The trial investigated the efficacy of Keytruda combined with carboplatin and paclitaxel, followed by Keytruda alone. The findings were significant: in patients whose cancer was mismatch repair proficient (pMMR), the treatment reduced the risk of disease progression or death by 40%. For those with dMMR tumors, the risk reduction was even more pronounced at 70%, when compared to a placebo combined with carboplatin and paclitaxel, followed by placebo alone.

The approval of Keytruda for this new indication adds another vital treatment option for patients with advanced or recurrent endometrial carcinoma, offering hope for better management of this challenging condition. This development underscores the importance of ongoing research and clinical trials in expanding the therapeutic landscape for cancer patients.