FDA Approves Keytruda Plus Pemetrexed for Advanced Malignant Pleural Mesothelioma

The FDA approved Keytruda (pembrolizumab) plus pemetrexed and platinum chemotherapy for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.

This disease is a cancer that develops in the thin tissue that covers the lungs and lines the chest wall, known as the pleura.

This approval was based on findings from the KEYNOTE-483 trial, according to a release from the FDA. The trial included patients who had not previously received systemic therapy for advanced/metastatic disease.

KEYNOTE-483 Trial Findings

Patients were randomly assigned to receive either Keytruda for up to two years plus pemetrexed and platinum-based chemotherapy for up to six cycles, or chemotherapy alone. The main focus of the study was to assess overall survival rates and other key endpoints.

• Median overall survival for the Keytruda plus chemotherapy group was 17.3 months compared to 16.1 months in the chemotherapy alone group.
• The confirmed overall response rate was 52% for the Keytruda group compared to 29% for chemotherapy alone.

Side Effects and Safety Profile

According to findings published in The Lancet, treatment-related severe (grade 3) side effects occurred in 27% of the Keytruda group, with serious side effects leading to hospital admissions in 18% of these patients.

As the standard treatment is platinum-pemetrexed chemotherapy, this combination with Keytruda could represent a significant advancement in cancer treatment for those diagnosed at an advanced stage.