Rivoceranib plus Airuika demonstrates improvement for survival in patients with unresectable hepatocellular carcinoma, a subset of liver cancer.
The treatment combination of rivoceranib (apatinib) and Airuika (camrelizumab) has shown survival improvements for patients with unresectable hepatocellular carcinoma (uHCC), as reported in a press release from Elevar Therapeutics Inc.
Rivoceranib is an oral tyrosine kinase inhibitor (TKI), which inhibits a main pathway for tumor angiogenesis (formation of new blood vessels), known as vascular endothelial growth factor receptor 2 (VEGFR-2). VEGFR-2 inhibition limits tumors from growing and diseases from progressing, as Elvar explained in the press release.
Hepatocellular carcinoma (HCC) is considered the most common form of liver cancer, noted in the press release. HCC typically occurs in individuals who have chronic liver diseases, including cirrhosis that was caused by an infection from hepatitis B or hepatitis C. Additionally, HCC is known to have a poor prognosis and does not have many treatment options, therefore making it more medically urgent, as stated in the press release. Unresectable hepatocellular carcinoma (uHCC) refers to a common form of liver cancer that cannot be surgically removed.
The Food and Drug Administration (FDA) has accepted a new drug application (NDA) for rivoceranib, which is to be combined with Airuika (camrelizumab), an anti-PD-1 immune checkpoint inhibitor, for front-line treatment in patients with uHCC, according to the press release.
“Rivoceranib plus (Airuika) has demonstrated the potential to improve the lives of those confronted with unresectable hepatocellular carcinoma,” said Saeho Chong, the CEO of Elevar. “With the FDA’s acceptance of our new drug application, we are pleased to reach another milestone in the development of this combination therapy. We look forward to working closely with the FDA during this review process and are focused on making the combination commercially available as quickly as possible should we gain approval.”
A phase 3 study from Elevar Therapeutic Inc. included 543 patients who were randomly assigned into subgroups. The purpose for this study was to analyze the overall survival (OS, the period from diagnosis or treatment where patients are still alive), progression-free survival (PFS, the period during and after treatment of cancer when the disease does not get worse) and the overall response rate (ORR, percentage of the treatment group who have a partial or complete response to treatment within a given period) in patients with uHCC receiving rivoceranib plus Airuika. These results were compared with patients with uHCC receiving only Nexavar (sorafenib, a type of chemotherapy).
The OS for patients who received the rivoceranib and Airuika combination was 22.1 months, whereas patients who received Nexavar alone had an OS of 15.2 months. The median PFS was 5.6 months for patients who received rivoceranib plus Airuika and 3.7 months for patients who received Nexavar alone. Furthermore, the ORR percentage for rivoceranib plus Airuika was 25.4%, compared to 5.9% for Nexavar, as stated in the press release.
Although the trial had the participants randomly assigned into subgroups, the press release noted that these results were generally consistent across each of the groups within the study. Thus, the press release emphasized that “the data suggested the combination confers a benefit in a global uHCC population.” The press release also established that rivoceranib plus Airuika benefited patients who had hepatitis C virus-based etiology (cause for disease) and non-viral etiology.
Moving forward, Elevar plans to develop rivoceranib as a monotherapy used to treat adenoid cystic carcinoma (ACC, an uncommon type of cancer that typically develops in the salivary glands and the head and neck region). The biopharmaceutical company also has plans to develop rivoceranib as mono and combination therapies for other tumor cell types.
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