HLB subsidiary Elevar Therapeutics has submitted a new drug application to the US Food and Drug Administration for its rivoceranib drug candidate plus camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC), which is the most common type of liver cancer.

The application is supported by positive results from the Phase III CARES 310 randomised, open-label, international trial.

The trial enrolled 543 patients and was carried out at 95 sites across 13 countries and regions worldwide.

Rivoceranib plus camrelizumab showed prolonged overall survival and progression-free survival as well as an enhanced overall response rate, as against a standard first-line treatment for uHCC, sorafenib.

Efficacy was consistent across all subgroups of the trial.

The therapy combination offered benefit in a global uHCC population and showed efficacy among patients with hepatitis C virus-based etiology and non-viral etiology.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In February 2023, China’s National Medical Products Administration approved rivoceranib and camrelizumab combination therapy as a first-line treatment for liver cancer.

Rivoceranib is an oral TKI, while camrelizumab is a PD-1 inhibitor.

Elevar Therapeutics CEO Saeho Chong stated: “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.”

Elevar is also developing rivoceranib as a monotherapy to treat adenoid cystic carcinoma (ACC) and as mono and combination therapies in other types of tumour cells.