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FDA Approves First-Line Pembrolizumab Plus Chemotherapy for Patients With Unresectable Advanced Malignant Pleural Mesothelioma
On September 17th, 2024, the US Food and Drug Administration (FDA) approved pembrolizumab plus pemetrexed and platinum-based chemotherapy as first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma. This approval was based on efficacy results from the KEYNOTE-483 study.
In this open-label trial, 440 patients with unresectable advanced or metastatic malignant pleural mesothelioma were randomized on a 1-to-1 basis to receive up to 2 years of pembrolizumab plus 6 cycles of pemetrexed and platinum-based chemotherapy (n = 222) or 6 cycles of pemetrexed and platinum-based chemotherapy alone (n = 218). The primary end point was overall survival (OS). Key secondary end points included progression-free survival (PFS), objective response rate (ORR), and duration of response, assessed by blinded independent central review.
At analysis, median OS was 17.3 months in the pembrolizumab arm and 16.1 months in the chemotherapy arm (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.64 to 0.98; P = .0162). Median PFS was 7.1 months in both study arms. Confirmed ORR was 52% in the pembrolizumab arm and 29% in the chemotherapy arm and median duration of response was 6.9 months and 6.8 months, respectively.
The recommended dosage of pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression or unacceptable toxicity, for up to 2 years.
Source:
FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma. Accessed on September 18, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-unresectable-advanced-or-metastatic-malignant-pleural
