Cancer researchers say the VEGF-inhibitor nintedanib (Ofev) extended mesothelioma survival by more than five months in patients on standard chemotherapy in a new trial.
That is among the findings of a recently-published Phase II study of nintedanib as an adjunct therapy to pemetrexed (Alimta) and cisplatin for malignant pleural mesothelioma.
Nintedanib Trial Details
Nintedanib is currently used to treat idiopathic pulmonary fibrosis and some types of non-small cell lung cancer.
To test its effectiveness in mesothelioma treatment, the LUME-Meso trial, a multi-center trial sponsored by drug maker Boehringer Ingelheim, recruited 87 people with either epithelioid or biphasic pleural mesothelioma. Patients could not have received any chemotherapy previously and were required to have a good performance status, meaning they had few other serious health problems.
Study subjects were randomized to receive the standard combination of mesothelioma chemotherapy drugs with the addition of either 200 mg of nintedanib or a placebo twice a day. Patients could undergo up to six 21-day cycles of the treatment, after which they received nintedanib or the placebo as a monotherapy (by itself) until their mesothelioma began to progress again.
Drug Appears to Slow Mesothelioma Progression
Although it is too early to say that nintedanib definitely extends mesothelioma survival, the preliminary results of the Phase II trial are encouraging, especially for people with the most common type of mesothelioma.
“Benefit was evident in epithelioid histology, with a median overall survival gain of 5.4 months and median progression free survival gain of 4 months,” reports Federica Grosso, the Italian researcher whose name appears first on the report in the latest issue of the Journal of Clinical Oncology.
While 6.8% of patients had to discontinue the use of nintedanib due to side effects, that was actually less than half of the number of patients who had the same reaction to the placebo drug.
VEGF Inhibition and Mesothelioma Treatment
VEGF is a protein which stimulates the formation of new blood vessels which are needed to support the growth of mesothelioma tumors. Emerging evidence also suggests that VEGF may suppress the immune system’s response to malignant mesothelioma and other cancers.
Bevacizumab (Avastin), another VEGF inhibitor, made headlines in 2016 when the French-led MAPS study found that adding it to standard chemotherapy extended mesothelioma survival by 23 percent.
The nintedanib trial will now move into the Phase III confirmation part of the study, which will eventually include a total of 450 pleural mesothelioma patients.
Grosso, F, et al, “Nintedanib Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma: Phase II Results From the Randomized, Placebo-Controlled LUME-Meso Trial”, September 11, 2017, Journal of Clinical Oncology, Epub ahead of print