Phase III LUME-colon 1 trial data on Vargatef (nintedanib) shows improved progression-free survival but not overall survival in metastatic colorectal cancer- Boehringer

Vargatef (nintedanib), from Boehringer, improves progression-free survival but not overall survival in patients with metastatic colorectal cancer who are not responding to standard therapies, according to results of the phase III LUME-colon 1 trial. LUME-colon 1 was the first phase III trial of nintedanib in patients with metastatic colorectal cancer refractory to all available treatments including chemotherapy and biological therapies. Patients had to be in good general condition (defined as performance status 0 and 1) and have good organ function. The trial included 768 patients who were randomised 1:1 to nintedanib or placebo.

All patients received best supportive care. The co-primary endpoints were progression-free survival and overall survival. Nintedanib significantly improved median progression-free survival compared to placebo (1.5 vs 1.4 months). There was no difference in overall survival between the two groups. Disease control was improved with nintedanib compared to placebo (26% vs 11%). Serious adverse events occurred in 39% of patients taking nintedanib and 35% on placebo. Some 14% of patients in the nintedanib group discontinued treatment due to adverse events, compared to 11% in the placebo group. Data were presented at the ESMO 2016 Congress in Copenhagen.

Comment: Nintedanib appears to delay disease progression and increases the rate of stable disease but these gains are lost when it comes to overall survival. This seems to be in contrast to regorafenib and trifluridine/tipiracil which both showed increases in both progression-free survival and overall survival in this line of treatment. More data is needed to explain the findings and understand how strong the benefit of nintedanib really is.