Pierre Gholam, MD, discusses his thoughts on a phase 3 trial which evaluated camrelizumab plus rivoceranib vs sorafenib in the first-line for patients with unresectable hepatocellular carcinoma.
Pierre Gholam, MD, professor at Case Western Reserve University School of Medicine in Cleveland, Ohio, discusses his thoughts on a trial (NCT03764293) which evaluated camrelizumab (AiRuiK) and rivoceranib vs sorafenib (Nexavar) in the first-line for patients with unresectable hepatocellular carcinoma (HCC).
In the phase 3 study, the PD-1 inhibitor camrelizumab was combined with the VEGFR2 tyrosine kinase inhibitor (TKI) rivoceranib. Findings showed that this combination significantly improved progression-free and overall survival vs treatment with sorafenib among patients with HCC.
Regarding safety, the combination was generally well-tolerated, and the safety profile was in line with each individual agent and the underlying disease.
0:08 | This was a study primarily from China where these 2 agents are compared to sorafenib. In the setting, the combination achieved the median overall survival of 22.1 months vs 15.2 months for sorafenib. I think it's notable that the baseline characteristics of the patients included a very strong emphasis on patients whose liver disease was driven by hepatitis B. About roughly 76% of the patients had hepatitis B.
0:48 | Aside from that, the overall characteristics of the patients were fairly similar to what one would expect in a first-time study. The objective response rate for the combination was 25.4 months and for sorafenib alone, it was 5.9 months.
1:08 | The adverse events that were reported were fairly on par with what one would expect in the setting of a combination of an immune checkpoint inhibitor and TKI. I think that the conclusion from all the data that we reported in this study is that this may be a viable combination, certainly in the subset of patients with hepatitis B driven disease. We'll see whether this combination takes its way through the regulatory process towards potential approval in the [United States] and Northern Europe.