The pathways that the drug uses are a potent intracellular inhibitor of tyrosine kinases. It targets platelet derived growth factor receptors (PDGFR) a and B, vascular endothelial growth factor receptor VEGFR 1,2, and 3. FGFR 1,2 1nd 3 fibroblast growth factor receptors.
The LUME-Meso phase 11 trial in patients, showed patients given this drug by mouth plus the standard chemotherapy of pemetrexed and cisplatin had significantly longer progression –free survival than those treated with a placebo and the standard therapy. Overall survival was also longer with Nintedanib (18.3 vs. 14.5 months.)
The company Boehringer Ingelheim applied and was granted approval as an orphan drug status for the drug Nintedanib for the treatment of malignant pleural mesothelioma by the United States Food and Drug Administration in December 2016. Currently Nintedanib, under the tradename Offev, is approved for the treatment of idiopathic pulmonary fibrosis.
In 2011, a clinical trial of patients who have idiopathic pulmonary fibrosis, a debilitating disease that affects the lungs, characterized by disease progression that includes lung deterioration and scarring. The disease is difficult to predict but the mean survival time from diagnosis is 2.5 to 3.5 years. This study in which 432 patients compared BIBF 1120 with a placebo and found those who took the drug Ofev had a decline in their rate of reduction of lung function, with fewer acute exacerbations and preserved the quality of life of the participants. Nintedanib was approved by the Federal Drug Administration in 2014 for the treatment of idiopathic pulmonary fibrosis.
The recommended dose is 150mg of Nintedanib is twice a day by mouth. It should be taken with food. It is not recommended for patients with liver disease, depending on the stage of the disease.
One of the most important thing to know is that OFEV can cause birth defects. Women should not become pregnant while taking OFEV,
Some of the more common side effects are elevation in liver function tests, diarrhea, nausea and vomiting. Decreased appetite was also reported. A small number of patients had thromboembolic events that have led to myocardial infarctions- heart attacks, strokes, and small number of gastrointestinal perforation.
Currently there are 4 Clinical Trials on www.clinicaltrials.gov listed for mesothelioma and Nintedanib. Three are recruiting and one is not yet recruiting. The LUME-Meso phase ll trial is a multicenter worldwide trial, with sites in the United States. The second trial is to be based in Europe, and is not yet recruiting. The third trial listed is based in the United States and is for treatment of recurrent mesothelioma with Nintedanib. The fourth trial is based in France for many solid tumor cancers, including mesothelioma and nintedanib.
We have reviewed the 2 clinical trials for Nintedanib and malignant pleural mesothelioma. One is being tested as a drug option for recurrence. The second is being given along with first line chemotherapy. The research is exciting and the results promising. Ask your mesothelioma doctor if your disease might benefit from these clinical trials.