FDA Approves Pembrolizumab and Chemotherapy as a Standard of Care in Advanced Mesothelioma

FDA Approval of Pembrolizumab and Chemotherapy

The FDA has granted approval for the frontline treatment of pembrolizumab combined with chemotherapy in patients diagnosed with unresectable advanced or metastatic malignant pleural mesothelioma.

This significant approval is supported by findings from the 2/3 KEYNOTE-483 trial (NCT02784171). The data revealed that patients receiving pembrolizumab plus chemotherapy experienced a statistically significant improvement in overall survival (OS) compared to those receiving chemotherapy alone.

Key Findings from the KEYNOTE-483 Trial

• Improved Overall Survival: The combination showed a reduction in the risk of death by 21% (HR, 0.79; 95% CI, 0.64-0.98; 2-sided P = 0.0324).
• Median OS: Patients on the combination treatment achieved a median OS of 17.3 months, compared to 16.1 months with chemotherapy alone.
• Progression-Free Survival (PFS): A significant improvement was also observed, with a PFS of 7.13 months for the combination versus 7.16 months for chemotherapy.
• Overall Response Rate (ORR): The ORR was significantly higher at 62% for the pembrolizumab combination compared to 38% with chemotherapy alone.

With these promising statistics, the approval of this combined therapy marks a hopeful new chapter for patients battling advanced mesothelioma and reaffirms the importance of clinical trials in developing innovative cancer treatments.