European Agency Signals Approval for Keytruda as First-Line Mesothelioma Treatment
核心洞察
The European Medicine Agency's CHMP has recommended Keytruda for first-line treatment of epithelioid malignant pleural mesothelioma (搜索) in adults.
This endorsement mirrors the FDA approval of Keytruda plus pemetrexed and platinum-based chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma (搜索).
The approval was based on the KEYNOTE-483 trial, which showed a statistically significant improvement in overall survival compared to chemotherapy alone.
Weeks after the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma (搜索), the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a similar endorsement, signaling its approval of the drug for use in adult patients with the epithelioid cell type of the rare, asbestos-related disease.
European Endorsement of Mesothelioma Drug Echoes American Approval
The CHMP’s positive opinion recommending the approval of the combination of medications for the treatment of mesothelioma (搜索), as well as approval from the FDA, followed the release of data from the phase 2/3 KEYNOTE-483 trial, which demonstrated statistically significant improvement in overall survival compared to treatment with chemotherapy alone. That study showed that patients who received the treatment had an overall survival of 17.3 months compared with 16.1 months for the chemotherapy group.
Though the study revealed no difference in median progression-free mesothelioma (搜索) survival between the combination treatment and the chemotherapy treatment, the overall response rate for the combination treatment was 52% compared to just 29% for the chemotherapy group.
Merck Applauds Approval
In response to the CHMP’s endorsement, Gregory Lubiniecki, MD, vice president of Oncology Clinical Research at Merck (搜索) Research Laboratories, said the following in a press release: “The CHMP’s positive opinion marks an important milestone for patients in Europe with non-epithelioid mesothelioma (搜索), who experience worse survival outcomes than patients with epithelioid mesothelioma. The positive CHMP opinion moves us closer to offering a new first-line treatment option with a proven OS benefit for certain patients in the European Union with this difficult-to-treat cancer.”
The groundbreaking study that preceded both agencies’ approval included adult patients with advanced pleural mesothelioma (搜索) unsuitable for surgery. None of the participants had prior systemic therapy, though chemotherapy more than one year before the study was permitted.