The FDA has granted Priority Review designation to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as a first-line treatment for patients with advanced or metastatic malignant pleural mesothelioma that can’t be removed through surgery.
The federal agency gave the pharmaceutical company the go-ahead based on positive data from a clinical trial, which found that Keytruda, combined with chemotherapy, significantly improved survival.
During Phase 3 of the trial, 440 malignant pleural mesothelioma patients were randomly selected to receive either 200 mg of Keytruda through IV every three weeks in addition to chemotherapy or chemotherapy alone.
Merck announced the trial results in June 2023 during the American Society of Clinical Oncology Annual Meeting. The trial showed that Keytruda added to chemotherapy reduced the risk of death by 21%. The median overall survival period was 17.3 months compared to 16.1 months for chemotherapy alone.
The FDA has set a target completion date of September 25, 2024, for its review of Merck’s application. The Priority Review designation makes that timeline shorter than usual.
Keytruda Gives Hope to Mesothelioma Patients
Mesothelioma is a rare but deadly form of cancer. Asbestos exposure is the only known risk factor. The most common form of this disease is pleural mesothelioma, which affects the membrane around the lungs.
The average 5-year survival rate for those diagnosed with malignant pleural mesothelioma is only 10%. That rate may be as high as 18% if the disease is detected in its early stages, but it could be as low as 7% if the tumors have spread.
Life expectancy for malignant pleural mesothelioma patients ranges from 12 to 21 months on average. Keytruda, in combination with chemotherapy, could extend the time patients have to spend time with their loved ones, even if it is only a few more months.
“Malignant pleural mesothelioma is typically diagnosed in advanced stages when curative surgery is not an option and progresses quickly,” said Dr. Gregory Lubiniecki, VP of oncology clinical research at Merck Research Laboratories, in a press release. “We continue to evaluate Keytruda in new and difficult-to-treat tumors and look forward to working with the FDA to help bring Keytruda as a potential treatment option to certain patients with advanced malignant pleural mesothelioma.”
