Ofev is a small-molecule enzyme inhibitor drug. It was meant to be a treatment for mesothelioma when paired with either cisplatin or pemetrexed chemotherapy. Up until now, Ofev has shown promising results. But that was the first two parts of the study.
In the phase III part of the study, Ofev failed. This study was run in multiple centers over 27 countries. This phase of the study consisted of 458 patients. Lancet Respiratory Medicine published the results. These results signaled another setback as far as mesothelioma treatment goes. The patients in the study were randomly assigned to pemetrexed or cisplatin chemotherapy paired with either Ofev or a placebo. Ofev did not show any advantage. Actually, it proved worse than the placebo. The average overall survival for patients with Ofev in this study was 14.4 months. In contrast, the average overall survival for patients with the placebo was, disappointingly, 16.1, one point seven months more than the actual drug. The average progression-free survival for those with Ofev was 6.8 months, and with the placebo, it was 7 months. The only measure in which the Ofev drug proved better was the quality of life and symptoms. But at that, Ofev was only slightly favored. Even though Ofev was favored, that doesn’t mean it was good. 44% of the patients with Ofev had severe side effects. A third required dose reduction. Even though this outcome is so terrible, in the past the drug looked promising. Doctors in both the United Kingdom and the United States have been using it with chemotherapy to treat certain lung cancers. In 2017 the U.S. Food and Drug Administration (FDA) granted Ofev an orphan drug designation. This encouraged its use without officially accepting it. With chemotherapy alone, the average progression-free survival rate of patients with mesothelioma is 4.7 months. In phase II of the study, the average progression-free survival rate of patients using both Ofev and chemotherapy was 9.4 months. And the average overall survival rate when using chemotherapy is 14.2 months, but in phase II with Ofev and chemotherapy, it was 18.3 months. In past trials Ofev did well with lung cancer because it softened the lungs, making it easier for the patient to breath. Sadly, this is not the first time that a highly praised drug has failed to live up to its expectations. Both Tremelimumab and Anetumab have failed. But they are still being tested. Not as the main drug for treatment, but as a part of drug combination treatments. The FDA has already approved Ofev for pulmonary fibrosis. Another study with Ofev is currently going on at Wayne State University in Detroit. This trial is using only Ofev for patients with recurrent pleural mesothelioma. While it is still showing no improvement with chemotherapy, a survival benefit has been seen for those with a higher platelet count in comparison with those with a lower platelet count. This has been noticed even though the study was not designed to consider that variable. This failure in Ofev, after so many failures of drugs of its kind, brings up a question. Should we continue trying to use this approach? Mesothelioma is a deadly cancer of the lining of the lungs. It is cancer caused solely by asbestos exposure. Those who are not exposed to asbestos don’t get mesothelioma. Call us today at (313) 437-4530 for a free estimate for asbestos testing and removal.