Dr. Jordi Bruix on Efficacy and Safety of Regorafenib in HCC After Sorafenib

Jordi Bruix, MD, head of the Barcelona Clinic Liver Cancer (BCLC) at University of Barcelona, discusses the efficacy, safety, and quality-of-life with regorafenib, a novel second-line agent that is currently being considered for approval by the FDA for second-line systemic therapy for patients with hepatocellular carcinoma (HCC) who progressed on sorafenib.

The clinical improvement demonstrated with regorafenib is very relevant, says Bruix.

In the phase III RESORCE trial, regorafenib reduced the risk of death by 37% (HR 0.63; 95% CI 0.50-0.79; p<0.001).

This is a large improvement for patients in terms of life expectations.

Importantly, it is also well tolerated, says Bruix. Regorafenib had a bad reputation in colorectal patients because in some patients, it was poorly tolerated. This was because many patients had undergone several other treatments before receiving regorafenib, says Bruix.

In the RESORCE trial only 10% of patients had to interrupt treatment because of adverse events. This means that 90% of the patients tolerated the drug properly, with some dose adjustments.

Study investigators also looked at patient reported outcomes and quality of life, and there was no clinical impairment that is clinically significant due to regorafenib. Having a drug that is well-tolerated, effective, and safe is exciting, says Bruix.