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Bayer submits supplemental NDA for Stivarga for advanced HCC
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Bayer announced it has submitted a supplemental New Drug Application to the FDA for Stivarga as a second-line systemic treatment for patients with unresectable hepatocellular carcinoma.
The supplemental NDA submission is indicative of data from the phase 3 RESORCE trial, which investigated Stivarga (regorafenib, Bayer HealthCare) in patients with unresectable HCC whose disease progressed during treatment with Nexavar (sorafenib, Bayer HealthCare).
“Regorafenib is the first treatment to demonstrate overall survival benefit in the second-line setting for unresectable HCC in clinical trials and, if approved, has the potential to change the treatment landscape for patients who progress on sorafenib,” Jordi Bruix, MD, head of the Barcelona Liver Clinic Group, Hospital Clinic, University of Barcelona, Spain, said in a press release.
In the study, 573 patients were matched two to one to receive either regorafenib or placebo. Results showed patients treated with regorafenib had a longer median overall survival compared with patients treated with placebo plus best supportive care (10.6 months vs. 7.8 months; HR = 0.62; 95% CI, 0.5-0.78). These data were first presented by Bruix at the European Society of Medical Oncology 18th World Congress on Gastrointestinal Cancer in June. Bruix presented updated data from RESORCE at the European Society for Medical Oncology annual congress in October and told Healio.com/Hepatology the data showed that patients who underwent treatment with regorafenib had an overall 37% reduction in the risk for mortality compared with the placebo group.
“[This was] based on the hazard ratio of 0.63 (95% CI, 0.50-0.79),” Bruix told Healio.com/Hepatology. “We were also able to present additional data, which showed regorafenib did not negatively impact the Quality of Life of patients with HCC. These positive data show the potential of regorafenib to become the new standard of care for patients with unresectable hepatocellular carcinoma who progress on sorafenib.”
Disclosure: Bruix reports consulting for AbbVie, Arqule, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, BTG, Gilead Sciences, Kowa, Novartis, Onxeo, OSI, Roche and Terumo.