ASCO GI 2022 | RENOBATE: investigating regorafenib plus nivolumab as 1st-line therapy for unresectable HCC

Changhoon Yoo, MD, PhD, Asan Medical Center, Seoul, Republic of Korea outlines the Phase II RENOBATE (NCT04310709) clinical trial investigating regorafenib plus nivolumab as first-line therapy for patients with unresectable hepatocellular carcinoma (uHCC). Regorafenib and nivolumab are approved agents for the management of uHCC and there is preclinical evidence indicating potential synergism between the antiangiogenic and immune checkpoint inhibiting treatments, such that regorafenib enhances the antitumor activity of nivolumab in this patient population. This generated the rationale of the Phase II trial investigating the combination of regorafenib and nivolumab in the first-line setting. The primary endpoint was overall response rate (ORR) and the secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety profile. At the time of analysis, the primary endpoint was met, with the trial achieving an ORR of 31.2%. The median PFS was 5.5 months. The median OS was not reached at the time of analysis, however, at 6 months the OS rate was 90.4%. The adverse events were manageable, with no unexpected adverse events exhibited for patients receiving regorafenib and nivolumab. This interview took place at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2022.