Ofev Drug Fails in Mesothelioma Clinical Trial

Ofev (nintedanib), a once-promising drug for mesothelioma, has failed to slow disease progression in a clinical trial. The immunotherapy drug was part of a multicenter study across 27 countries. Ofev had shown considerable potential in previous studies.

The new trial results, published by Lancet Respiratory Medicine, are another setback in the use of certain immunotherapy drugs to treat mesothelioma.

In the most recent trial, 458 patients were randomly assigned to cisplatin and pemetrexed chemotherapy in addition to Ofev or a placebo. 

Ofev offered no advantage. The median progression-free survival for patients taking Ofev was 6.8 months compared to seven months in patients taking the placebo. Overall, the median survival rate with the Ofev group was 14.4 months compared to 16.1 months for the placebo group. Additionally, 44% of patients receiving Ofev experienced serious side effects. 

Based on these results, the study of Ofev has been halted. The outcome was disappointing, as there had been earlier successes with the drug. Doctors in the U.S. and U.K. had been using the drug in combination with chemotherapy to treat certain types of lung cancer. 

Other immunotherapy drugs have shown more promising results. 

"Patients experiencing a relapse were given nivolumab (Opdivo) and ipilimumab (Yervoy), and in both cases 44% and 50% of patients experienced slowed cancerous cell growth," says Vogelzang Law.

Japan has already approved the use of nivolumab (under the brand name "Opdivo") to treat pleural mesothelioma in specific cases. The study used for approval in Japan involved 34 patients. Each patient received 240 milligrams of nivolumab every two weeks until they experienced "progressive disease or unacceptable toxicity."

Ten of the 34 participants had positive results, which means that the antibody was successful at stopping PD-1 and PD-L1 binding while helping the immune system attack tumors. Among these patients, 68% saw their tumors stagnate or decrease in size.

Median overall survival for these patients was 17.3 months, longer than the life expectancy for many people suffering with pleural mesothelioma. 

Nivolumab is already approved for use in the U.S. for many diseases, including some lung cancers and melanoma. But the drug would have to go through rigorous clinical trials and testing before it could be approved for use for mesothelioma. 

Baylor College of Medicine's Lung Institute is running a clinical trial using nivolumab paired with an adenovirus known as MTG201. Nivolumab's ability to target the PD-1 and PD-L1 relationship allows the immune system to remain activated. The adenovirus offers a quicker cell death by releasing antigens that encourage nivolumab to attack the disease directly.