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NINTEDANIB and Malignant Pleural Mesothelioma

The drug Offev or Nintedanib, also known as BIBF 1120, is currently showing promise in treating patients with malignant pleural mesothelioma. Nintedanib is classified as an oral triple angiokinase inhibitor. Nintedanib targets receptors that play a role in tumor growth and development of metastasis in malignant pleural mesothelioma. The cancer cells release growth factors, bind to activate growth factor. In order for the tumor to spread or metastasize angiogenesis takes place. Angiogenesis is blood vessel formation. The tumor needs new blood vessels to grow. Nintedanib uses anti-angiogenic strategy that is different from other approved treatments. Nintedanib is a small molecule that targets three receptors known to be involved in angiogenesis.

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 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.

What’s in the Genes? New Research on Malignant Pleural Mesothelioma

malignant pleural mesotheliomaCutting edge scientific research in mesothelioma is technical, intricate, and can be confusing to most of us. On February 29, 2016, in the journal Nature in the category, Nature Genetics, an article was published entitled: “Comprehensive Genomic Analysis of Malignant Pleural Mesothelioma Identifies Recurrent Mutations, Gene Fusions and Splicing Alterations”. The lead author is Dr. Raphael Bueno.

This research was a collaborative effort involving scientists, physicians, bioinformatics groups, and personnel at the tumor bank at the Brigham and Women’s Hospital. It was supported partly by grants to Dr. Bueno from the National Cancer Institute, the International Mesothelioma Program at Brigham and Women’s Hospital, and Genentech Inc.

The article is written in scientific research form. What the researchers did was analyze tissue from the tumor specimens from 216 cases of malignant pleural mesothelioma, regardless of the type of mesothelioma. Because mesothelioma is a rare cancer, previous studies have been limited by the numbers of tissue samples available. This research had the samples available to study and looked for genetic alterations in the tumors. The article states: “Understanding the genetic alterations that drive MPM [malignant pleural mesothelioma] is critical for successful development of diagnostics, prognostics, and personalized therapeutic modalities.” For example in previous studies, loss of function mutations in gene CDKN2A have been identified in a small number of samples of patients with malignant pleural mesothelioma. The scientific understanding of the mutation of genes in malignant pleural mesothelioma is limited. The article explains: “However, understanding of the mutational landscape of MPM is not yet sufficient to affect classification or treatment strategies.”

Tumors are currently classified as epithelioid, biphasic , and sarcomatoid. This research identified four distinct sub types: sarcomatoid, epithelioid, biphasic-epithelioid (biphasic-E) and biphasic-sarcomatoid (biphasic-S).

The research also identified mutations (changes) in 10 genes and recurrent mutations in several genes. They also recognized changes and alterations in signaling pathways to several genes. This information is vital in furthering research into the treatment and allowing for potentially more treatment options for patients.

What does this all mean to someone diagnosed with malignant pleural mesothelioma today?

Mesothelioma has long been difficult to diagnose and as a result most people do not get diagnosed until the disease is advanced. The diagnosis is difficult to make. Past research has proven that every person’s mesothelioma tumor is as different as every person’s fingerprint.   This research clearly identified four distinct molecular subtypes of malignant pleural mesothelioma and recurrent mutations in several genes expressed in the tumor sample. This is a building block towards taking this research and incorporating it into a clinical test or series of tests to tailor patient care to a pathway that is scientifically proven effective. This is an important step in the progress toward a cure for malignant pleural mesothelioma.

One of the potential ways that this research could impact future treatment of mesothelioma patients is in the development of drugs for specific tumor types and gene mutations.

Scientific research and progress is built on previous research. For this research 100 sources were referenced in the article.

Important research like this takes time, resources, collaboration and dedication of many people. For a patient and their families diagnosed with malignant pleural mesothelioma, this research hopefully will make treatment options more targeted and ultimately more successful.

The full text of the article is located here.

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Your message to us will be held in strict confidence. All requests for information by mesothelioma patients and their family members will be answered within 24 hours. Mesothelioma Treatment and Care Guides are sent to mesothelioma patients and families by overnight delivery.

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