Boehringer Ingelheim’s Ofev Fails in Clinical Trials for Lung Cancer

Jul 30, 2019 | Challenging Results, Mesothelioma, News, Non-Small Cell Lung Cancer

Boehringer Ingelheim’s Ofev Fails in Clinical Trials for Lung Cancer

Ofev was a promising drug for mesothelioma (a form of lung cancer). Unfortunately, the search for a cure hit another barrier as recently this promising immunotherapy drug combined with chemotherapy failed to slow disease progression in a phase III study.

The Study

Ofev (nintedanib) was studied in a multi-center study covering 27 counties. The trial included 458 patients randomly selected to recieve pemetrexed and cisplatin chemotherapy plus either Ofev or a placebo.

The Results

As published in Lancet Repository Medicine, the study results revealed no advantage. Median progression-free survival was 6.8 months for patients assigned Ofev as compared with seven months for those with the placebo.

What is Ofev?

Also called nintedanib, Ofev is an oral medication used for the treatment of idiopathic pulmonary fibrosis along with other medications for some types of non-small-cell lung cancer. Common side effects include abdominal pain, vomiting and diarrhea. It is a small molecule tyrosine-kinase inhibitor, targeting vascular endothelial growth factor receptor, fibroblast growth factor receptor, and platelet derived growth factor receptor.

Approvals

The drug was approved for idiopathic pulmonary fibrosis in October 2014 by the Food and Drug Administration and received a positive opinion from the European Medicines Agency on November 2014, being approved there in January 2015. It is also approved in Canada, Japan, Switzerland, and other countries.

Nintedanib was approved for combination of non-small-cell lung cancer in the EU in 2014.

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