HLB submits new drug application to FDA for Rivoceranib liver cancer drug

HLB Co. announced on May 17 that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of Rivoceranib, a targeted anti-cancer drug, as a first-line treatment for liver cancer. It is intended for a combination therapy with Camrelizumab, which is an immune checkpoint inhibitor developed by Hengrui Pharmaceuticals. 

HLB holds the global patent for Rivoceranib. HLB, through its US subsidiary Elevar Therapeutics, has been developing the combination therapy of Rivoceranib and Camrelizumab as a first-line treatment option for liver cancer in collaboration with Hengrui Pharmaceuticals. 

A global phase 3 clinical trial (CARES 310) was conducted on 543 patients in 13 countries. Results from the clinical trial demonstrated that after the Rivoceranib-Camrelizumab combination therapy, complete remission (CR) was reported in three patients with median overall survival (mOS) of 22.1 months, median progression-free survival (mPFS) of 5.6 months, and objective response rate (ORR) of 25.4%. In the Sorafenib (control drug)-treated group, complete remission (CR) was reported in one patient with mOS of 15.2 months, mPFS of 3.7 months, and ORR of 25.4%. 

Earlier in February 2023, the combination therapy of Rivoceranib and Camrelizumab was approved in China as a first-line treatment for liver cancer. 

“The combination of camrelizumab and rivoceranib shows distinct promise as a potential therapy for advanced hepatocellular carcinoma,” said Ahmed Omar Kaseb, M.D., professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston. “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.”

Rivoceranib inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), thereby blocking the supply of oxygen and nutrients which are essential for cancer growth. It is an oral drug of the TKI class.

“Expectations for approval are high in that there is no licensed first-line treatment for liver cancer based on a combination therapy of a TKI anti-cancer drug with an angiogenesis-inhibiting mechanism and an immuno-anticancer drug,” said the company. Elevar has started preparing for its commercialization in the US to facilitate sales immediately after the approval. 

HLB Life Sciences holds the Korean sales rights for Rivoceranib and some profit rights in Europe and Japan, and Hengrui Pharmaceuticals holds the sales rights in China. Eleva holds the global sales right for other regions.

Write to Min-soo Han at hms@hankyung.com