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Page Updated August 30, 2019

Disappointing Results in Ofev Mesothelioma Clinical Trial

Page Reviewed and Edited by

Mesothelioma Attorney Paul Danziger

Immunotherapies, treatments that harness the immune system to fight cancer cells, hold a lot of promise for all types of cancer and even treatment for mesothelioma, a difficult type of cancer. Some treatments have been successful in some patients, while others have fallen short. One immunotherapy drug that held great promise for mesothelioma patients has unfortunately recently failed in clinical trials.

Ofev and Immunotherapy

Ofev is the brand name for an immunotherapy drug known as nintedanib. Developed by Boehringer Ingelheim, nintedanib is currently used to manage idiopathic pulmonary fibrosis associated with non-small-cell lung cancer and for some cases of lung cancer.

This drug works by targeting growth factor receptors, which are part of the process of the development of pulmonary fibrosis, scarring in the lungs. For treating cancer, Ofev may help by slowing the formation of new blood vessels that carry nutrients and oxygen to cancer cells. Without these blood vessels tumor growth slows and may even stop or result in cell death. Unlike chemotherapy, this kind of immunotherapy drug is specific and targets cancer cells, not healthy cells.

The Mesothelioma Clinical Trial – Hopes and Failures

Ofev has shown some promise in managing lung cancers, which gave researchers and patients hope that it could also treat mesothelioma. Early trials were promising. The results with lung cancer were successful enough that the U.S. Food and Drug Administration granted orphan drug status for Ovef, allowing it to be used for some mesothelioma patients even without final approval.

In the second phase of the clinical trial to use Ofev for mesothelioma patients, results were positive. Patients who received Ofev along with chemotherapy had a survival time of 18.3 months compared to 114.2 months for patients who only received chemotherapy. The progression-free survival times were 9.4 months and 4.7 months, respectively.

While these results indicated Ofev with chemotherapy could extend a mesothelioma patient’s life, the next round of the trial proved disappointing. The most recent results showed know benefits. A group of 458 patients received cisplatin chemotherapy and pemetrexed, an immunotherapy drug. Some got a placebo as well, while others received Ofev.

The overall survival time was 16.1 months for patients who received the placebo. It was just 14.4 months for those who received Ofev. In terms of symptoms and side effects the Ofev group faired only slightly better. Unfortunately, due to these results the study was halted.

More Results with Ofev Expected

While the phase III results for Ofev disappointed patients and researchers, other trials are ongoing and provide hope. A clinical trial being conducted at Wayne State University is about to complete phase II and results are expected soon. The trial is using Ofev alone in patients with pleural mesothelioma. There are other factors to be considered than those tested in the failed trial. Researchers in this current trial hope that they will see better, more hopeful results.

Whether the results from the Wayne State trial will be positive remains to be seen. In the meantime, researchers continue to test new drugs, develop more promising immunotherapies, and give patients with this terrible cancer a little more hope.