NDA Submitted for Rivoceranib/Camrelizumab Combo in Frontline Unresectable HCC

A new drug application (NDA) has been submitted to the FDA for the combination of rivoceranib and camrelizumab as a first-line treatment option for patients with unresectable hepatocellular carcinoma (uHCC).¹

The application is based on findings from the phase 3 CARES 310 study (NCT03764293), which showed that rivoceranib, a small-molecule VEGFR-2 TKI, and camrelizumab, a PD-1 inhibitor, elicited a statistically significant and clinically meaningful prolonged overall survival (OS) and progression-free survival (PFS) vs sorafenib (Nexavar) in the first-line setting for uHCC. The combination also improved overall responses vs sorafenib.

Specifically, results showed that the median OS for camrelizumab plus rivoceranib was 22.1 months (95% CI, 19.1-27.2) compared with 15.2 months (95% CI, 13.0-18.5) for sorafenib, leading to a 36% reduction in the risk of death (HR, 0.62; 95% CI 0.49-0.80; 1-sided P <.0001).

Additionally, the median PFS for the combination was 5.6 months (95% CI, 5.5-6.3) vs. 3.7 months (95% CI, 2.8-3.7) for sorafenib (HR, 0.52; 95% CI, 0.41-0.65; 1-sided P <.0001). The confirmed objective response rates (ORRs) were 25.4% (95% CI 20.3-31.0) and 5.9% (3.4-9.4) for camrelizumab/rivoceranib and sorafenib, respectively.

“The combination of camrelizumab and rivoceranib shows distinct promise as a potential therapy for advanced hepatocellular carcinoma,” Ahmed Omar Kaseb, MD, professor in the Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston, said in a news release. “As an oncologist focused on evolving the standard of patient care in HCC, I am encouraged by Elevar’s NDA filing and look forward to the completion of the FDA’s review process.”

The randomized, open-label, international CARES 310 trial comprised 543 patients and was conducted at 95 study sites across 13 countries/regions.

The results were found to be similar across prespecified subgroups, Elevar, the developer of rivoceranib, stated in the news release.

“Elevar Therapeutics’ submission of a new drug application for the combination of rivoceranib and camrelizumab marks an important milestone in our effort to provide an improved treatment option for patients confronted with uHCC,” Saeho Chong, chief executive officer of Elevar stated in a news release. “We thank the many physicians, institutions and patients who have contributed to rivoceranib’s development, and we look forward to working closely with the FDA during its evaluation period.”

The combination therapy of rivoceranib and camrelizumab was approved by China's National Medical Products Administration in February 2023 as a first-line treatment for liver cancer.

Reference

1. Elevar Therapeutics submits new drug application to FDA for combination of rivoceranib and camrelizumab as first-line treatment option for unresectable hepatocellular carcinoma. News release. Elevar Therapeutics. May 17, 2023. Accessed May 17, 2023. https://www.biospace.com/article/releases/elevar-therapeutics-submits-new-drug-application-to-fda-for-combination-of-rivoceranib-and-camrelizumab-as-first-line-treatment-option-for-unresectable-hepatocellular-carcinoma/