Treatment with nintedanib significantly improved progression-free survival compared with placebo among heavily pretreated patients with metastatic colorectal cancer (mCRC) regardless of whether patients had received prior regorafenib, according to a paper being presented at the 2017 Gastrointestinal Cancers Symposium.1

The double-blind, phase 3 LUME-Colon 1 trial ( Identifier: NCT02149108) previously demonstrated that nintedanib, a triple angiokinase inhibitor of VEGFR, PDGFR, and FGFR, significantly improves progression-free survival (hazard ratio [HR], 0.58; 95% CI, 0.49-0.69; P < .0001), but not overall survival (HR, 1.01; 95% CI, 0.86-1.19; P = .8659), vs placebo among patients with mCRC after failure of standard therapies.

In a prespecified subanalysis, researchers evaluated the impact of prior regorafenib treatment on the effect of nintedanib therapy among 768 patients with mCRC randomly assigned 1:1 to receive nintedanib plus best supportive care or placebo plus best supportive care. Of those, 37% had received prior regorafenib.

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Among patients who had previously received regorafenib, those treated with nintedanib were 39% less likely to progress or pass away than those given placebo (HR, 0.61; 95% CI, 0.47-0.79). Among regorafenib-naive patients, those in the nintedanib group had a 38% reduced risk of progression or death (HR, 0.62; 95% CI, 0.51-0.76).

Median progression-free survival was 1.5 months with nintedanib and 1.4 months with placebo in both regorafenib-pretreated patients and regorafenib-naive patients.

There was no significant difference in median overall survival between the nintedanib and placebo arms in regorafenib-pretreated patients (HR, 0.90; 95% CI, 0.69-1.17), or those who had previously received regorafenib (HR, 1.09; 95% CI, 0.89-1.33).

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Nintedanib was tolerable regardless of prior regorafenib use; the most common adverse events were diarrhea, nausea, and vomiting in both subgroups.

According to the authors, these findings support the use of continuous antiangiogenic therapy in this setting.


  1. Lenz H-J, Yoshino T, Argiles G, et al. Nintedanib (N) plus best supportive care (BSC) versus placebo (P) plus BSC for the treatment of patients (pts) with colorectal cancer (CRC) refractory to standard therapies: Subanalysis of the phase III LUME-colon 1 study in pts by prior regorafenib (R) treatment. J Clin Oncol. 2017;35(suppl):4S. Abstract 660.