The benefit of Bayer’s regorafenib, marketed under the name Stivarga, in patients with previously treated metastatic colorectal cancer (mCRC) has been confirmed in the phase IIIb CONSIGN study. Safety profile and progression-free survival rates were consistant with phase III trial results.
“We began CONSIGN at the suggestion of the authorities and to fulfil the wishes of patients and doctors for a larger expanded access. Today we report on safety and progression-free survival in a large cohort of patients that more closely resembles daily clinical practice than the pivotal registration trial.”
The CONSIGN study involved over 2,800 patients at 188 sites in 25 countries, receiving regorafenib for a median of 2.5 months. The estimated progression-free survival was 2.7 months.
Dr Dirk Arnold, director of the Department of Medical Oncology, Klinik für Tumorbiologie in Freiburg, Germany, commented:
“CONSIGN confirms the efficacy and safety data of the randomised phase III CORRECT and CONCUR trials. The merit of CONSIGN is that it translates phase III data into the clinical routine since patients had similar characteristics and pre-treatment to what we see in daily practice.
There were no surprising findings in terms of toxicity. All of the adverse events were quite class specific and also likely manageable.”
Regorafenib is a multi-kinase inhibitor that targets angiogenic, stromal and oncogenic receptor tyrosine kinase. It has been approved by the FDA for metastatic colorectal cancer since 2012.