The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for rivoceranib plus camrelizumab to treat unresectable hepatocellular carcinoma (HCC).
HCC is a rare liver cancer characterized by nodules composed of neoplastic epithelial cells with hepatocellular differentiation. The majority of tumors are caused by chronic liver disease or exposure to exogenous agents. Common symptoms include abdominal pain, weight loss, hepatosplenomegaly, jaundice, and ascites.
This CRL is the second for Elevar Therapeutics’ treatment, following a CRL issued in May 2024 for manufacturing concerns. Reasons for the second CRL have not been disclosed by the FDA.
The submission for approval for rivoceranib, a VEGFR2-targeted TKI, and camrelizumab, an anti–PD-1 antibody, followed results from the phase 3 CARES-310 clinical trial.
A total of 543 patients were randomized to receive the combination therapy or sorafenib. At a median follow-up of 22.1 months (combination) and 14.9 months (sorafenib), the median overall survival was 23.8 months and 15.2 months, respectively. After 24 months, this rate was 49% for patients receiving the combination and 36.2% for those on sorafenib. Progression free survival was 5.6 months for the combination therapy and 3.7 months for sorafenib. Additionally, median overall response rate was 26.8% in the combination group with a median duration of response of 17.5 months compared to 5.9% overall response rate and 9.2 month median duration of response for the sorafenib group.
The most common treatment emergent adverse events included hypertension, increased aspartate aminotransferase, palmar-plantar erythrodysesthesia syndrome, increased blood bilirubin, decreased platelet count, diarrhea, and increased gamma-glutamyl transferase. Discontinuation rates were 17.6% for camrelizumab, 16.9% for rivoceranib, 4.4% for both therapies, and 4.8% for sorafenib.
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To learn more about HCC and other rare hematologic conditions, visit https://checkrare.com/diseases/hematologic-disorders/
