Late-stage data, which showed significant overall and progression-free survival benefits in unresectable hepatocellular carcinoma patients, supports Elevar’s New Drug Application filed in May 2023.
Pictured: Illustration of a liver with tumors/iStock, libre de droit
A pre-specified primary analysis of the Phase III CARES 310 trial showed that Elevar Therapeutics’ cancer candidate rivoceranib, when combined with fellow investigational drug camrelizumab, significantly improved survival in patients with unresectable hepatocellular carcinoma, the company announced Monday.
Patients who received the drug combination saw a 48% reduction in the risk of death or disease progression, an effect that was significantly better as compared with Bayer’s Nexavar (sorafenib), the standard first-line treatment for unresectable hepatocellular carcinoma (uHCC).
At the interim analysis, overall survival was also significantly longer in the rivoceranib-camrelizumab group versus Nexavar.
Results of CARES 310 showed that “camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma,” Elevar CEO Saeho Chong said in a statement.
The study’s findings were published Monday in the medical journal The Lancet.
CARES 310 is a randomized, open-label and international trial enrolling more than 540 patients with unresectable or metastatic HCC who had not yet been treated with any systemic regimen. Rivoceranib was given as a 250-mg oral dose once a day, while 200-mg camrelizumab was administered intravenously every two weeks.
The study also assessed the safety of the combination regimen and found a higher prevalence of side effects. Treatment-related serious adverse events arose in 24% of patients who received the rivoceranib-camrelizumab combo, as opposed to only 6% in the sorafenib group.
Two treatment-related deaths were documented, one involving multiple organ dysfunction in a patient who received the investigational treatment, and another involving respiratory failure and circulatory collapse in a sorafenib-treated patient.
Rivoceranib is a small-molecule tyrosine kinase inhibitor that works by blocking the VEGFR-2 pathway, which tumors hijack to create a rich network of blood vessels to sustain their malignant growth. Camrelizumab, developed by Chinese biotech Hengrui Pharma, is a monoclonal antibody that blocks the PD-1 receptor, allowing immune players to target and kill cancer cells.
Leveraging the two approaches to cancer treatment, and backed with promising data from CARES 310, Elevar in May 2023 submitted a New Drug Application (NDA) to the FDA for the drug combination. At the time, the company highlighted the regimen’s efficacy results which were “generally consistent across all subgroups” and suggested that it could be beneficial to a “global uHCC population.”
The FDA accepted the NDA last week but did not grant it Priority Review. The target action date is on May 16, 2024.
Elevar is continuing to evaluate rivoceranib as a single-agent treatment for adenoid cystic carcinoma, as well as exploring its potential in other tumor cell types.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
