The success of the CARES 310 Trial Phase III (NCT03764293 ) was reported this week in Biospace by Elevar Therapeutics. The combination of two drugs, rivocera, and camrelizumab proved to be a significant improvement over Nexavar (sorafenib), Bayer’s standard treatment for inoperable hepatocellular carcinoma (HCC).
The midterm analysis was also impressive showing a much longer progression-free overall survival in the new group as opposed to Nexavar. The results of the trial were recently published in The Lancet.
The international trial enrolled over 540 patients who had metastatic or inoperable HCC. The participants had not yet received treatment with full-body (systemic) medication. Elevar’s CEO said that the results of CARES 310 indicate significant potential for rivoceranib plus camrelizumab as an improved therapy for advanced hepatocellular carcinoma.
However, in checking the new combination for safety, treatment-related adverse events were listed at 24% while the sorafenib group showed 6%. In addition, there were two deaths related to treatment. The first death involved multiple organ dysfunction. The patient had been treated with the investigational regime. The second death involved circulatory collapse and respiratory failure in a patient who had been treated with sorafenib during the trial.
About Rivoceranib and Camrelizumab
When the vascular endothelial growth factor receptor-2 (VEGFR-2) is activated, it creates an abnormal expansion of blood vessels that support the growth of solid tumors. Therapeutic interventions such as Rivoceranib that inhibit the VEGFR-2 pathway have therefore become a mainstay of cancer treatment.
Rivoceranib is a tyrosine kinase inhibitor. It blocks the VEGFR-2 pathway. Camrelizumab is a monoclonal antibody that was developed by Hengrui Pharma that blocks PD-1 and fosters the exposure and killing of cancer cells.
In May of 2023, Elevar submitted its New Drug Application. Elevar stressed the regimen’s efficiency results as being consistent in most areas of subgroups and highlighted its benefit across a global HCC.The NDA was accepted but Elevar was not yet granted Priority Review. The target date is May 2024.
Meanwhile, Elevar continues to look at rivoceranib as a single-agent intervention for adenoid cystic carcinoma and is considering its potential in other tumor subtypes.