FDA Approves Merck’s Keytruda for First-Line Mesothelioma Treatment

Merck & Co, known as MSD outside the US and Canada, has obtained approval from the US Food and Drug Administration (FDA) for the use of Keytruda (pembrolizumab) in treating malignant pleural mesothelioma. This anti-PD-1 therapy has been sanctioned for use in conjunction with pemetrexed and platinum-based chemotherapy as an initial treatment for adults with unresectable advanced or metastatic forms of the disease.

In 2022, over 30,000 new cases of mesothelioma, a cancer originating in the linings of various body parts, were reported worldwide. Pleural mesothelioma, which emerges in the lining of the lungs, represents about 75% of all malignant mesothelioma cases and is known for its rapid progression.

The FDA’s approval is based on encouraging results from the phase 2/3 IND.227/KEYNOTE-483 trial. This study revealed that Keytruda, when combined with chemotherapy, reduced the risk of death by 21% compared to chemotherapy alone. Patients receiving the combination treatment had a median overall survival of 17.3 months, in contrast to 16.1 months for those receiving only chemotherapy. Additionally, the combination therapy showed significant enhancements in both progression-free survival and overall response rate.

Gregory Lubiniecki, Vice President of Oncology Clinical Research at Merck Research Laboratories, expressed satisfaction with the approval, stating, "We’re pleased to offer a new first-line treatment option for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, a disease where prognoses are generally poor."

Keytruda functions by enhancing the immune system’s ability to detect and combat tumor cells. It is already approved in the US for multiple indications, including specific forms of breast, lung, and bladder cancer. This recent approval follows a series of other authorizations for Keytruda, including an expanded FDA approval three months ago for a regimen combining Keytruda with carboplatin and paclitaxel to treat primary advanced or recurrent endometrial carcinoma. In January, the FDA also approved Keytruda for use with chemoradiotherapy in newly diagnosed cervical cancer patients with stage 3 to 4a disease.

Currently, there are over 1,600 ongoing trials involving Keytruda, including studies evaluating its effectiveness when combined with Merck and Moderna’s investigational skin cancer vaccine.