First-line Immunotherapy Approved for Advanced Mesothelioma
Pembrolizumab plus chemotherapy was approved for certain patients with untreated malignant pleural mesothelioma.
The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda) with the chemotherapeutic pemetrexed and platinum-based chemotherapy as first-line therapy for patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Pembrolizumab is an immune checkpoint inhibitor, a type of immunotherapy that helps keep immune cells active against cancer cells. Pembrolizumab has been approved for several different cancer types, as well as for any cancer type with certain biomarkers, but this is its first approval specifically for malignant pleural mesothelioma.
rare cancer that can develop after exposure to asbestos (shown here).
Pembrolizumab is the third immune checkpoint inhibitor approved to treat malignant pleural mesothelioma (a combination of nivolumab [Opdivo] and ipilimumab [Yervoy] was approved in 2020 as first-line treatment for some patients with this disease).
The latest approval was based on results from KEYNOTE-483, a randomized, open-label phase II/III trial that enrolled patients with unresectable advanced or metastatic malignant pleural mesothelioma who had not received any previous systemic therapy for advanced or metastatic disease. Patients were randomly assigned (1:1) to receive either pembrolizumab plus pemetrexed and platinum-based chemotherapy (pembrolizumab arm) or pemetrexed and platinum-based chemotherapy (chemotherapy-only arm).
Treatment responses were observed in 52% of patients in the pembrolizumab arm, compared with 29% of patients in the chemotherapy arm. Further, patients in the pembrolizumab arm lived a median of 17.3 months, while those in the chemotherapy arm lived 16.1 months; this difference was statistically significant.
For the treatment of malignant pleural mesothelioma, the recommended dose for pembrolizumab is 200 mg every three weeks or 400 mg every six weeks until disease progression, unacceptable toxicity, or two years have passed.
Malignant pleural mesothelioma is a rare type of cancer that develops in the pleura (the lining of the chest cavity and lungs) and is most commonly diagnosed in people exposed to asbestos. It is estimated that 3,000 individuals are diagnosed with mesothelioma each year in the United States.
The FDA rendered its decision on September 17, 2024.
