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Phase III Results Support Novel Combination for Unresectable Hepatocellular Carcinoma

By: Julia Fiederlein Cipriano, MS
Posted: Thursday, August 24, 2023

According to Arndt Vogel, MD, of Hannover Medical School, Germany, and colleagues, the anti–PD-1 antibody camrelizumab in combination with the VEGFR2-targeted tyrosine kinase inhibitor rivoceranib (also known as apatinib) significantly improved progression-free and overall survival versus the multitargeted tyrosine kinase inhibitor sorafenib alone in patients with unresectable or metastatic hepatocellular carcinoma. The results of the multicenter phase III CARES-310 trial, which were published in The Lancet, also seemed to support a manageable safety profile for this novel first-line treatment option.

“Camrelizumab plus rivoceranib showed a positive benefit-to-risk profile versus sorafenib,” the investigators commented. “The incorporation of an orally administered, antiangiogenic tyrosine kinase inhibitor in the immune combination regimen could provide clinicians with more flexibility in treatment selection in practice.”

Systemic therapy–naive patients were randomly assigned to receive either 200 mg of intravenous camrelizumab every 2 weeks in combination with 250 mg of oral rivoceranib once daily (n = 272) or 400 mg of oral sorafenib monotherapy twice daily (n = 271). At the primary analysis of progression-free survival and interim analysis of overall survival, the median durations of follow-up were 7.8 and 14.5 months, respectively.

Treatment with camrelizumab plus rivoceranib versus sorafenib was found to significantly prolong the median durations of progression-free (5.6 vs. 3.7 months; hazard ratio [HR] = 0.52) and overall (22.1 vs. 15.2 months; HR = 0.62) survival. Hypertension (camrelizumab plus rivoceranib: 38%; sorafenib: 15%), palmar-plantar erythrodysesthesia syndrome (12% vs. 15%), elevated aspartate aminotransferase levels (17% vs. 5%), and elevated alanine aminotransferase levels (13% vs. 3%) were the most frequently reported grade 3 or 4 treatment-related adverse events. Treatment-related serious adverse events were observed in 24% and 6% of patients who received camrelizumab plus rivoceranib and sorafenib, respectively. One treatment-related death was documented in each arm.

Disclosure: For full disclosures of the study authors, visit thelancet.com.


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