Bayer Announces Positive Phase 3 Data for Stivarga

Bayer announced today that results from the Phase III RESORCE trial show that Stivarga (regorafenib) tablets achieved a median overall survival improvement in patients with unresectable hepatocellular carcinoma (HCC) who progressed after treatment with Nexavar (sorafenib) tablets. The study, which will be presented during the European Society of Medical Oncology (ESMO) 18th World Congress on Gastrointestinal Cancer (WCGC) in Barcelona, Spain, found that patients taking Stivarga had a median overall survival of 10.6 months versus 7.8 months for placebo plus best supportive care (HR 0.62; 95% CI 0.50-0.78; p)

“The global incidence of liver cancer continues to increase and has more than tripled in the United States over the last three decades, and currently there are no proven or approved systemic second-line treatment options for patients with advanced HCC,” said Dr. Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain. “The improvement in overall survival seen with regorafenib in the RESORCE study signals the addition of a potential option in this treatment setting.”

In addition to the primary endpoint of the study, all secondary endpoints, which were assessed by modified Response Evaluation Critieria in Solid Tumors (mRECIST) and RECIST 1.1 criteria, were also met. Median progression-free survival was 3.1 months in patients taking regorafenib vs 1.5 months in the control group (HR 0.46; 95% CI 0.37‒0.56; p

In the study, safety and tolerability were generally consistent with the known profile of regorafenib. The most common grade ≥3 treatment-emergent adverse events occurring more frequently in the regorafenib group (regorafenib vs placebo group) were hypertension (15.2% vs 4.7%), hand-foot skin reaction (12.6% vs 0.5%), fatigue (9.1% vs 4.7%), and diarrhea (3.2% vs 0%).

Bayer plans to submit data from the RESORCE study as the basis for marketing authorization of regorafenib in the treatment of unresectable HCC in the U.S. and other markets worldwide in 2016.

“Bayer has a deep heritage in the exploration of therapeutic options for HCC, since the introduction of sorafenib for unresectable HCC in 2007,” said Mark Rutstein, vice president of Oncology Clinical Development at Bayer. “We are committed to exploring the use of kinase inhibitors across difficult-to-treat cancers, so that we can better understand the full clinical utility of these therapies.”

About the Phase III Study

The RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] clinical trial is a randomized, double blind, placebo controlled, multicenter Phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) whose disease has progressed after treatment with sorafenib. The trial enrolled approximately 573 patients who were randomized in a 2:1 ratio to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC.

Patients received 160 mg regorafenib once daily, for 3 weeks on/1week off, or placebo with 28 days constituting one full treatment cycle. The primary endpoint of the study was overall survival, and secondary efficacy endpoints were time to progression, progression-free survival, objective tumor response rate and disease control rate. Safety and tolerability of patients were continuously monitored.