Bayer reports positive Phase III RESORCE trial results of Stivarga to treat HCC

29th June 2016 (Last Updated June 29th, 2016 18:30)

German-based pharmaceutical company Bayer has reported positive results from the Phase III RESORCE trial of Stivarga (regorafenib) tablets to treat unresectable hepatocellular carcinoma (HCC).

HCC

German-based pharmaceutical company Bayer has reported positive results from the Phase III RESORCE trial of Stivarga (regorafenib) tablets to treat unresectable hepatocellular carcinoma (HCC).

Stivarga is a prescription medicine indicated to be used for colon or rectal cancer that has spread to other parts of the anatomy and after the patient has been administered with chemotherapy medicines.

The Phase III RESORCE (REgorafenib after SORafenib in patients with hepatoCEllular carcinoma) clinical trial is a randomised, double-blind, placebo-controlled, multicentre study to evaluate Stivarga in treating patients with HCC who had a prior administration of sorafenib.

It involved about 573 patients who were randomised in a 2:1 ratio to be treated with either regorafenib and best supportive care (BSC) or placebo with BSC.

The study primarily focused on the overall survival of the patients.

The secondary endpoint of the trial focused on determining the time taken to progress, progression-free survival, objective tumour response rate and disease control rate.

The trial had also evaluated the safety and tolerability of Stivarga in patients.

"The improvement in overall survival seen with regorafenib in the RESORCE study signals the addition of a potential option in this treatment setting."

According to the assessment made by modified Response Evaluation Critieria in Solid Tumours (mRECIST) and RECIST 1.1 criteria, both the primary and secondary endpoints of the trial were met, while the safety and tolerability of Stivarga was consistent throughout the study.

University of Barcelona IDIBAPS CIBEREHD Spain Hospital Clinic BCLC Group liver unit Dr Jordi Bruix said: "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.

"The improvement in overall survival seen with regorafenib in the RESORCE study signals the addition of a potential option in this treatment setting."

Within the US, Stivarga is used to treat patients with metastatic colorectal cancer who have received a prior treatment with fluoropyrimidine-based, oxaliplatin-based and irinotecan-based chemotherapy.


Image: Autopsy specimen displaying HCC in a hepatitis C positive patient. Photo: courtesy of Ed Uthman via Wikipedia.