Nintedanib in combination with oxaliplatin, leucovorin, and fluorouracil (mFOLFOX6) showed efficacy as first-line therapy in patients with metastatic colorectal cancer (mCRC) and a manageable safety profile, a new study published online ahead of print in the journal Annals of Oncology has shown.
For the open-label, phase 1/2 study, researchers sought to evaluate the safety and efficacy of nintedanib in combination with chemotherapy compared with bevacizumab plus chemotherapy as first-line treatment in patients with mCRC.
Researchers enrolled 128 patients with histologically confirmed mCRC and randomly assigned them 2:1 to receive nintedanib 200 mg twice daily plus mFOLFOX6 or bevacizumab combined with mFOLFOX6.
Results showed that 9-month progression-free survival was 62.1% with nintedanib vs 70.2% with bevacizumab. Confirmed objective responses were observed in 63.5% and 56.1% of patients, respectively.
In regard to safety, 37.6% of patients in the nintedanib arm experienced serious adverse events compared with 53.7% of patients in the bevacizumab arm.
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Pharmacokinetic analyses demonstrated no interaction between nintedanib and the components of mFOLFOX6.
The findings suggest that further studies are warranted to evaluate the efficacy and safety of nintedanib 200 mg twice daily combined with mFOLFOX6 as first-line treatment for this patient population.
Nintedanib is already approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis and is being studied in various solid tumors.
- van Cutsem E, Prenen H, D’Haens G, et al. A phase I/II, open-label, randomised study of nintedanib plus mFOLFOX6 versus bevacizumab plus mFOLFOX6 in first-line metastatic colorectal cancer patients. Ann Oncol. 2015. [epub ahead of print]. doi: 10.1093/annonc/mdv286.