Mesothelioma: KEYTRUDA® / Pembrolizumab + Chemo Receives FDA Approval

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The FDA has approved pembrolizumab (Keytruda) in combination with platinum-based chemotherapy for the treatment of unresectable, advanced, or metastatic malignant pleural mesothelioma. This approval, based on the results of the KEYNOTE-483 trial, offers new hope to patients facing this aggressive cancer.

Key Findings from the KEYNOTE-483 Trial:

Overall Survival (OS): Patients treated with pembrolizumab and chemotherapy experienced a median OS of 17.3 months, compared to 16.1 months for those who received chemotherapy alone, reflecting a 21% reduction in the risk of death.

Progression-Free Survival (PFS): Both groups had a median PFS of 7.1 months, but pembrolizumab provided a significant improvement in overall response.

Objective Response Rate (ORR): 52% of patients responded to pembrolizumab plus chemotherapy, compared to just 29% in the chemotherapy-alone group.

Duration of Response (DoR): Patients in the pembrolizumab arm experienced a median DoR of 6.9 months, compared to 6.8 months in the chemotherapy arm.

Understanding Mesothelioma:

Malignant pleural mesothelioma is a rare and aggressive cancer primarily caused by asbestos exposure. For many patients, surgical removal of the tumor is not possible, making new treatments like pembrolizumab a vital option.

Safety Profile:

Common side effects included fatigue, nausea, and constipation, with more severe immune-mediated conditions like pneumonitis and colitis requiring careful monitoring.

Pembrolizumab's approval marks the first new treatment for mesothelioma in over 15 years, offering a new standard of care for this challenging disease.

Sources:
https://www.fda.gov/drugs/resources-i...

https://www.merck.com/news/fda-approv...