Researchers have reported more promising results from an international, multicenter phase II clinical trial of the drug nintedanib, moving it another step closer to standard-of-care treatment for pleural mesothelioma.
Nintedanib is a small-molecule enzyme inhibitor being studied as a way to increase the effectiveness of chemotherapy on mesothelioma and certain types of lung cancer.
Researchers presented the results earlier this month at the World Conference on Lung Cancer in Vienna, Austria.
The randomized clinical trial treated mesothelioma patients with a placebo and chemotherapy (pemetrexed/cisplatin) or nintedanib and chemotherapy.
Patients given nintedanib did considerably better with 9.4 months of progression-free survival and 18.3 months of overall survival. The patients treated with the placebo had only 5.7 months of progression-free survival and 14.5 months of overall survival.
“We are very encouraged by these recent data,” Professor Giorgio Scagliotti, University of Torino, chairman of the department of oncology and lead investigator, said in a news release. “The results have led to an extension of the study into a phase III confirmatory trial that is now underway and will provide further insight into the potential of nintedanib for patients with mesothelioma.”
The U.S. Food and Drug Administration approved nintedanib, also known by the brand name Ofev, only for pulmonary fibrosis. The drug effectively softens the lungs and relieves breathing problems.
“It is potentially a new way of approaching [this disease],” medical oncologist Dr. Rama Balaraman said earlier this year. “It’s causing a lot of excitement.”
Oncologists in Europe already use nintedanib in combination with the chemotherapy drug docetaxel to treat certain lung cancer patients, but it has not been approved for any other cancer treatments.
Doctors in the U.S. are hoping the recent clinical trial success will speed up the FDA approval process.
Pleural mesothelioma is a rare and aggressive cancer caused by inhalation of asbestos fibers. It starts in the thin membrane surrounding the lungs and can spread throughout the thoracic cavity.
Chemotherapy is part of the standard-of-care treatment, but it works only sporadically and is unsustainable. Although therapies have improved in recent years, the life expectancy after diagnosis is still only 6-18 months.
Boehringer Ingelheim, a pharmaceutical company based in Germany, produces the drug and has pushed the clinical trial process.
“Current treatment options for unresectable malignant pleural mesothelioma are limited, and we are focused on developing treatment options that will fit the need of patients,” Dr. Victoria Zazulina, head of solid tumor oncology for Boehringer, said in the news release. “Our oncology research is driven by a determination to improve the lives of patients who are battling cancer.”
Previous studies have shown that nintedanib obstructs enzymes that allow tumors to develop new blood vessels, inhibiting tumor cell growth.
The U.S. portion of the phase III trial is recruiting patients now in:
To participate in the phase III trial, patients must have the epithelioid subtype of the disease and not yet taken systemic chemotherapy. Patient Advocates at The Mesothelioma Center can answer questions about eligibility.
Nintedanib also is part of a separate phase I clinical trial combining it with immunotherapy drug pembrolizumab. However, this trial is only taking place in Paris.