Boehringer Ingelheim’s Phase 2 clinical trial investigating nintedanib in malignant pleural mesothelioma showed improvements in both progression-free and overall survival compared to treatment with chemotherapy alone.
The company is now recruiting patients for the Phase 3 extension part of the LUME-Meso trial (NCT01907100), aiming to confirm the Phase 2 data.
Researchers presented the data at the recent 17th IASLC World Conference on Lung Cancer in Vienna, Austria.
The trial randomized patients to treatment with a combination of nintedanib and Alimta (pemetrexed) or Platinol (cisplatin) chemotherapy, or a placebo and chemotherapy.
Data presented at the meeting showed that progression-free survival in the nintedanib group was 9.4 months. This was significantly longer than the 5.7 months observed in the placebo group. Overall survival also increased, from 14.5 months to 18.3 months for patients treated with nintedanib.
“No targeted therapies are currently approved for the treatment of mesothelioma, a rare and difficult to treat cancer,” Giorgio V. Scagliotti, a professor at the University of Torino in Italy, chair of the Department of Oncology, and lead study investigator, said in a news release.
“We are very encouraged by these recent data. The results have led to an extension of the study into a Phase 3 confirmatory trial that is now underway and will provide further insight into the potential of nintedanib for patients with malignant pleural mesothelioma,” he said.
The most common adverse events that occurred more often in patients receiving active treatment, compared to placebo, were low numbers of immune cells called neutrophils. These low counts were present in 34% of nintedanib-treated patients, compared to 10% in the placebo group.
Elevated liver enzymes were found in 14% and 2% in the nintedanib and placebo groups, respectively, and an increase in the enzyme gamma glutamyltransferase was found in 14% of the active treatment group compared to no increase in the placebo group.
In the European Union, nintedanib is approved — in combination with the chemotherapy drug Taxotere (docetaxel) — for adults with a specific lung cancer type. For this use, nintedanib is marketed as Vargatef. So far, the drug has not been approved for any other cancer treatments.
In the U.S., nintedanib is FDA-approved only for treatment of lung fibrosis under the brand name Ofev.