Malignant pleural mesothelioma (MPM) is a cancer of the lining of the lungs, characterized by chest pain, shortness of breath, and dry cough. Nintedanib is a medication that targets various receptors and kinases that are implicated in MPM pathogenesis. This study aims to evaluate the safety of nintedanib when used in combination with pemetrexed and cisplatin in patients with unresectable MPM.
This randomized, double-blind, placebo-controlled, phase 3 trial included a total of 458 patients with unresectable epithelioid MPM. The patients were randomly assigned in a 1:1 ratio to receive 21-day cycles of nintedanib-cisplatin-pemetrexed (combination group, n=229) or matched placebo (placebo group). The primary outcome of the study was progression-free survival.
During a median treatment duration of 5.2 months and 250 events, no significant difference was found in the median progression-free survival between the nintedanib group (6.8 months) and the placebo group. (7.0 months). Neutropenia was the most commonly occurring grade 3 or 4 adverse event. The rate of serious adverse events was 44% in the nintedanib group and 39% in the placebo group.
The research concluded that nintedanib-cisplatin-pemetrexed combination therapy did not improve progression-free survival in patients with unresectable advanced malignant pleural mesothelioma.