On June 5, Anna Nowak, MD, PhD, of the University of Western Australia and member of the Meso Foundation’s Science Advisory Board, presented phase II results from LUME-Meso, a mesothelioma clinical trial sponsored by Boehringer Ingelheim, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
LUME-Meso is a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of nintedanib, an oral triple angiokinase inhibitor, in combination with the standard first-line chemotherapy of pemetrexed/cisplatin in malignant pleural mesothelioma patients.
The study included 87 patients with unresectable epithelioid or biphasic malignant pleural mesothelioma who had not received previous systemic chemotherapy. Patients were randomized into two arms of the study. The experimental arm received nintedanib in combination with pemetrexed/cisplatin followed by nintedanib alone until progression or toxicity. The placebo comparator arm received a placebo in combination with pemetrexed/cisplatin followed by a placebo alone until progression or toxicity.
The clinical trial yielded the following results:
- A 46% reduction in disease progression was demonstrated in the experimental arm vs. the placebo arm
- Median progression-free survival (PFS) improved by 3.7 months in the overall study population in the experimental arm compared to the placebo arm (9.4 vs. 5.7 months)
- Median PFS improved by 4 months in patients with an epithelioid cell type who received nintedanib vs. the placebo (9.7 vs. 5.7 months)
- Median overall survival (OS) improved by 4.1 months in the overall study population in the experimental arm compared to the placebo arm (18.3 vs. 14.2 months)
- Median OS improved by 5.4 months in patients with an epithelioid cell type who received nintedanib vs. the placebo (20.6 vs. 15.2 months)
- Drug-related adverse events (AEs) in patients who received nintedanib vs. patients in the placebo arm were 97.7% vs. 97.6%
- AEs led to trial discontinuation in only 3 (6.8%) patients in the experimental arm vs. 7 (17.1%) in the placebo arm
“The data shows that this combination strongly inhibits cell growth and an increased survival in the experimental arm when compared to the placebo arm, indicating the combination may have some promising clinical significance,” commented Gleneara Bates, MS, MSW, PhD (c), Director of Research and Medical Outreach at the Meso Foundation.
The promising results show that adding nintedanib to the standard first-line treatment of pemetrexed/cisplatin gives a strong signal towards improved overall survival in malignant pleural mesothelioma, with the greatest clinical benefit being observed in patients with an epithelioid cell type who showed a median survival of 20.6 months.
“These results are from a randomized phase II trial and hence, whilst the study met its primary endpoint, it should not be considered practice changing. However, it encourages us all to enroll patients in the ongoing phase III trial to get a definitive answer as soon as possible. We can now be very hopeful that the LUME-Meso III trial may change our standard of care. Watch this space,” said Dr. Nowak in a statement to the Meso Foundation.
The LUME-Meso Phase III trial of nintedanib in mesothelioma is currently recruiting at trial sites worldwide. Click here to learn more.