The addition of nintedanib (Ofev) to standard of care pemetrexed (Alimta) plus cisplatin failed to delay disease progression in patients with unresectable malignant pleural mesothelioma, according to phase III results of the LUME-Meso study.
After a median treatment duration of more than 5 months, median progression-free survival was 6.8 months for patients assigned to nintedanib, an oral triple angiokinase inhibitor, compared with 7.0 months for those assigned to placebo (P=0.91), reported Giorgio V. Scagliotti, MD, PhD, of the University of Turin, San Luigi Hospital in Italy, and colleagues.
“Despite promising data from the phase II part of the LUME-Meso study, the primary endpoint (progression-free survival) was not met in the phase III part,” they wrote in the Lancet Respiratory Medicine. “New treatment options are still needed in patients with malignant pleural mesothelioma.”
In an editorial that accompanied the research, Michele Maio, MD, PhD, and Luana Calabrò, MD, PhD, both of the Center for Immuno-Oncology and the University Hospital of Siena in Italy, noted that the LUME-Meso trial is another in a series of trials over the last decade that have “now failed to demonstrate therapeutic efficacy from the targeting of angiogenesis with anti-vascular endothelial growth factor monoclonal antibodies, as well as with multitargeted small-molecule protein kinase inhibitors.”