Dr Gholam on Camrelizumab Plus Rivoceranib in Unresectable HCC

Pierre Gholam, MD, associate professor, Department of Medicine, School of Medicine, Digestive Health Research Institute, Case Western Reserve University, discusses findings from the phase 3 CARES-310 trial (NCT03764293) of camrelizumab plus rivoceranib in patients with unresectable hepatocellular carcinoma (HCC).

CARES-310 evaluated the PD-1 inhibitor camrelizumab in combination with the VEGFR-2 inhibitor rivoceranib vs the historical standard of care, sorafenib (Nexavar), in the frontline setting for patients with unresectable HCC, Gholam begins. The findings from this study, which were published in The Lancet, demonstrated that at a median follow-up of 7.8 months (interquartile range, 4.1-10.6), the camrelizumab/rivoceranib combination elicited a median progression-free survival of 5.6 months (95% CI, 5.5-6.3) vs 3.7 months (95% CI, 2.8-3.7) with sorafenib (HR, 0.52; 95% CI, 0.41-0.65; 1-sided P < .0001). Furthermore, at a median follow-up of 14.5 months (interquartile range, 9.1-18.7), the median overall survival favored the combination arm, at 22.1 months (95% CI, 19.1-27.2) vs 15.2 months (95% CI, 13.0-18.5) with sorafenib (HR, 0.62; 95% CI, 0.49-0.80; 1-sided P < .0001), Gholam reports.

The most common grade 3/4 treatment-related adverse effects (AEs) observed in this trial were hypertension (camrelizumab/rivoceranib arm, 38%; sorafenib arm, 15%), palmar-plantar erythrodysaesthesia syndrome (12%; 15%), increased aspartate aminotransferase (17%; 5%), and increased alanine aminotransferase (13% vs 3%). Twenty-four percent of patients in the camrelizumab/rivoceranib arm experienced serious treatment-related AEs vs 6% of those in the sorafenib arm.

CARES-310 primarily enrolled patients at sites in Asia, and small numbers of patients were also enrolled at sites in Europe and the United States, Gholam says. Therefore, the findings from this trial may be influenced by drivers of HCC that are common in Asia, such as hepatitis B, Gholam notes. However, these findings may still be generalizable to a more global population, Gholam emphasizes. Future regulatory decisions may define the optimal use of camrelizumab plus rivoceranib in patients with unresectable HCC, Gholam concludes.