On July 17, 2023 Elevar Therapeutics, a fully integrated biopharmaceutical company focused on improving treatment options for patients with limited or inadequate therapeutic choices, announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for rivoceranib, an investigational oral TKI, in combination with camrelizumab, a PD-1 inhibitor. The NDA seeks approval for the first-line treatment of unresectable hepatocellular carcinoma (uHCC). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for May 16, 2024.
“Rivoceranib plus camrelizumab has demonstrated the potential to improve the lives of those confronted with unresectable hepatocellular carcinoma. 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.”
– Saeho Chong, Elevar chief executive officer
The NDA is based on data from the Phase III CARES 310 study (NCT03764293). This international trial, conducted across 13 countries/regions with 543 patients, demonstrated that the combination of rivoceranib and camrelizumab achieved statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared to the standard first-line treatment, sorafenib, for uHCC.
Results from the trial showed that the median OS for camrelizumab + rivoceranib was 22.1 months, compared to 15.2 months for sorafenib. The combination therapy also demonstrated a longer median PFS of 5.6 months compared to 3.7 months for sorafenib. The confirmed objective response rate for camrelizumab + rivoceranib was 25.4%, while it was only 5.9% for sorafenib.
The efficacy of the combination therapy was consistent across different patient subgroups, suggesting its potential benefit for a global uHCC population. Notably, it showed efficacy in patients with both hepatitis C virus-based etiology and non-viral etiology, which represent the majority of HCC cases in the US
In China, the National Medical Products Administration (NMPA) approved the combination therapy of rivoceranib and camrelizumab as a first-line treatment for liver cancer in February 2023.
In addition to uHCC, Elevar is also investigating rivoceranib as a monotherapy for adenoid cystic carcinoma (ACC) and exploring its potential as a mono or combination therapy for other types of tumors.
