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Safety and efficacy of regorafenib determined in Phase III liver cancer trial

Data from the Phase III RESOURCE trial presented at the EMSO 18th Word Congress of Gastrointestinal Cancer (Barcelona, Spain) indicate that regorafenib increases survival rates in patients with hepatocellular carcinoma.

The oral multikinase inhibitor regorafenib has been determined to improve survival rates compared with placebo in individuals with hepatocellular carcinoma, potentially paving the way for a new second-line treatment.

After promising results in Phase I/II trials, the study’s principal investigator Jordi Bruix (Barcelona Clinic Liver Cancer Group) and colleagues enrolled 573 patients with intermediate- or advanced-stage hepatocellular carcinoma, who had all been previously treated with sorafenib. Patients were randomized 2:1 to either receive oral regorafenib (160 mg) or placebo once daily for 1–3 of each 4-week cycle, alongside best supportive care.

Patients treated with regorafenib demonstrated a 38% decrease in the risk of death and a 54% reduction in risk of disease progression or death compared with placebo, following a median 3.6 months of treatment.

The mean progression-free survival for regorafenib was 3.1 versus 1.5 months for placebo, while overall survival was higher in regorafenib-treated patients at 10.6 versus 7.8 months for placebo.

In total, 65.2% patients on regorafenib showed complete or partial response, compared with 36.1% response in those treated with placebo.

The current treatment for patients suffering from hepatocellular carcinoma consists of a single agent – sorafenib – many others having failed Phase I/II trials.

Bruix commented: “This is a very difficult to treat cancer but now we have an effective second-line agent, which is good news for the patients and also for the field as interest in further developments will be stimulated.”

Bruix also commented that future analysis of biomarkers could reveal whether there might be certain subgroups of patients likely to derive even greater benefit from regorafenib therapy.

Source: ESMO press release