The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, as a first-line treatment for unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
The approval is based on the Phase 3 CCTG IND.227/KEYNOTE-483 trial. In this trial, KEYTRUDA plus chemotherapy showed a statistically significant improvement in overall survival (OS) compared to chemotherapy alone. The risk of death was reduced by 21%, with a median OS of 17.3 months for the combination therapy compared to 16.1 months for chemotherapy alone.
KEYTRUDA plus chemotherapy improved progression-free survival (PFS) and overall response rate (ORR). Median PFS was 7.1 months for the combination therapy and 7.1 months for chemotherapy alone. ORR was significantly higher for the combination therapy at 52% compared to 29% for chemotherapy alone.
KEYTRUDA is an anti-PD-1 therapy that blocks the PD-1 protein in immune cells, allowing them to recognize better and attack cancer cells. It is generally well-tolerated, but immune-mediated adverse reactions may occur. Early identification and management of these reactions are crucial.
The approval of KEYTRUDA plus chemotherapy provides a new first-line treatment option for patients with MPM, a challenging disease with limited treatment options. This milestone reflects the ongoing commitment to advancing research and developing innovative therapies for patients with difficult-to-treat tumors.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
