There are also some risks of bleeding, gastrointestinal toxicities such as diarrhea and bowel perforation, and thrombosis. However, these AEs are familiar to those who have used other VEGF inhibitors. “I don’t think there’s a single medical oncologist who has not used sunitinib, sorafenib, axitinib, this cluster of drugs. Nintedanib is expected to be similar,” Vogelzang commented. Standard dosereduction criteria and the time off the drug, if needed, are built into LUME-Meso’s trial design.
Should this trial be successful, nintedanib could secure a new indication, because it is a registrational trial for the FDA and the European Medicines Agency. It also could be tested n other tumor types, particularly in non–small cell lung cancer. Nintedanib is being developed by Boehringer Ingelheim, which is also sponsoring the trial.
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- Zalcman G, Mazieres J, Margery J, et al; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial [published correction in Lancet 2016;387(10026):e24). Lancet. 2016;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6.
- Ofev [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2017.
- Nowak AK, Grosso F, Steele N, et al. Mature overall survival (OS) results from the LUME-Meso study of nintedanib (N) + pemetrexed/cisplatin (PEM/CIS) vs placebo (P) + PEM/CIS in chemo-naïve patients (pts) with malignant pleural mesothelioma (MPM) [ASCO abstract 8506]. J Clin Oncol. 2017;35(suppl). http://meetinglibrary.asco.org/ record/153088/abstract.