Phase III data confirms previous studies of Stivarga (regorafenib) in metastatic colorectal cancer- Bayer HealthCare

The Phase IIIb CONSIGN study has confirmed the benefit of Stivarga (regorafenib), from Bayer HealthCare, in patients with previously treated metastatic colorectal cancer (mCRC). CONSIGN was a prospective, observational study that was initiated to allow patients with mCRC access to regorafenib before marketing authorisation and to assess safety, which was the primary endpoint.

The randomised phase III CORRECT trial previously showed that regorafenib significantly improves survival in patients with pre-treated mCRC and led to regulatory approval. In CONSIGN, grade >3 adverse events occurred in 80% of patients. The estimated progression-free survival was 2.7 months and was similar across KRAS wild type and mutant subgroups. The safety profile and progression free survival were similar to phase III trial results. Data were announced at the ESMO 17th World Congress on Gastrointestinal Cancer.

Comment:Less pre-treatment may explain the larger gain of overall survival with regorafenib in the CONCUR trial compared to the CORRECT trial. An analysis of the characteristics and outcomes of patients in the CONCUR and CORRECT trials has confirmed the clinical benefit of regorafenib in patients with previously treated metastatic colorectal cancer. Overall survival improved in Asian and non-Asian patients and adverse events were similar across the two trials.