ESMO 2016

LUME study of nintedanib finds improved PFS, but no overall survival boost

Prof Eric Van Cutsem - University of Leuven, Leuven, Belgium

The LUME study was a study evaluating the role of nintedanib which is a multi-targeted tyrosine kinase inhibitor targeting VEGF, FGF, PDGF and we studied that drug in chemo-refractory colorectal cancer in a placebo randomised study, it was a phase III study, so in later lines of treatment, placebo controlled. We found that in this study nintedanib had some activity but the study, formally speaking, was negative because there were two co-primary endpoints, one which was a progression free survival and the other was a clear benefit. Nintedanib stopped the tumours more from growing than placebo, leading to a longer progression free survival but, however, there was no significant survival benefit for nintedanib versus placebo. We don’t have yet a full explanation why this is, despite some activity of the drug. Part of it is that patients on the placebo arm got a bit longer and more later lines of treatment and then we are looking further into the biology of the tumours also.

The bottom line message is that despite the fact that nintedanib has some activity the study is negative because one of the main primary endpoints being survival was not met so there was no survival benefit for patients treated with nintedanib in this situation. So that’s the main message of the trial.

How was toxicity managed?

Nintedanib, and that was one of the reasons why we looked at the drug, has clearly a very favourable safety profile. Of course when you give to patients a cancer drug there is always some toxicity but the toxicity was very limited and minimal and that’s, for sure, not the reason why the trial failed. Because there were very few patients who stopped their treatment because of toxicity also.