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Investigational Drug Nintedanib Found ‘Safe and Effective’ for MPM Patients

In December 2016, pharmaceutical company Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) had granted orphan drug designation to its new drug nintedanib (BIBF 1120) for the treatment of mesothelioma. Orphan drug designation is granted by the FDA to investigational compounds intended for the safe and effective diagnosis, treatment, or prevention of rare diseases or disorders that affect fewer than 200,000 people. 

The FDA’s decision was based in part on data from the Phase II cohort of the ongoing Phase II/III LUME-Meso trial. Now, the company has reported that nintedanib has been found “safe and effective” for patients with malignant pleural mesothelioma (MPM). In the trial, 44 of 87 patients treated with nintedanib showed improved progression free survival (PFS) and a trend for prolonged overall survival (OS). The greatest benefit was experienced by patients with epithelioid MPM, which is the most common and treatable subtype of mesothelioma. These patients showed a PFS of 9.7 months vs. 5.7 months and OS of 20.6 months vs. 15.2 months.

This study also showed that just 6.8% of adverse events in patients treated with nintedanib led to treatment discontinuation.

Nintedanib is “an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR 1-3) signalling pathways,” explains the company. “These three different angiokinase receptors, which are not yet targeted by any currently available therapies, play an important role not only in angiogenesis but also in tumor growth and the development of metastases.”

The findings of the study were announced at the International Association for the Study of Lung Cancer (IASLC) Multidisciplinary Symposium in Thoracic Oncology.

The success of nintedanib is just one example of how far treatment options have come in just the last seven years. The result is more MPM patients are living longer, more productive lives after being diagnosed.

If you have been diagnosed with mesothelioma, ask your doctor about clinical trials such as the LUME-Meso trial. This and other clinical trials are now recruiting at dozens of research centers across the U.S. Talk to your doctor today.

 

Sources

Grosso, F. "Nintedanib Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma: Phase II Results From the Randomized, Placebo-Controlled LUME-Meso Trial." Journal of Clinical Oncology. U.S. National Library of Medicine, 11 Sept. 2017. Web. 28 Oct. 2017.

"Nintedanib (BIBF 1120) in Mesothelioma." ClinicalTrials.gov. U.S. National Library of Medicine, 19 Oct. 2017. Web. 30 Oct. 2017.

"Nintedanib Granted Orphan Drug Designation for Treatment of Mesothelioma." Boehringer Ingelheim, 2016. Web. 28 Oct. 2017.

"Nintedanib Shows Promise for Malignant Pleural Mesothelioma." HemOnc Today, 16 Sept. 2017. Web. 28 Oct. 2017.