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Korean pharmaceutical company HLB unveiled its roadmap for adding novel anticancer treatments for three cancer types to its portfolio by 2026, as part of its bid to cement its position as an oncology-focused specialist following the anticipated U.S. approval of its targeted anticancer treatment, Rivoceranib, next month.

According to HLB, the U.S. Food and Drug Administration is set to decide on approval of Rivoceranib as a liver cancer treatment by March 20.

Upon securing the approval, HLB also plans to commercialize Rivoceranib as an adenoid cystic carcinoma (ACC) treatment by adding it into the U.S. National Comprehensive Cancer Network (NCCN) guidelines as a preferred regimen. The company has successfully completed the world's first Phase 2 clinical trials for the drug as an ACC treatment, and plans to add it in the NCCN guidelines before starting Phase 3 trials.

The company also seeks to file a new drug application (NDA) for RLY-4008 as a bile duct cancer treatment by the end of the year. RLY-4008 was initially developed by U.S. Relay Therapeutics, and was licensed last year to HLB's U.S. subsidiary, Elevar Therapeutics.

Along with bile duct cancer, HLB said that it plans to develop RLY-4008 into a tumor-agnostic drug.

Tumor-agnostic drugs are approved for cancer treatment based on biomarkers, regardless of which organ the cancer starts in. The FDA approved Merck's Keytruda in 2017 as the world's first tumor-agnostic drug, and it now stands as the pharmaceutical industry's biggest blockbuster.

According to HLB, Relay Therapeutics anticipated RLY-4008's potential as a tumor-agnostic therapy when it initiated Phase 1/2 clinical trials in 2020, and recruited patients not only with bile duct cancer but also with various other tumors.

Elevar said the recruitment for the bile duct cancer patient group has been completed, and it plans to expand patient groups across other solid tumor types to further validate RLY-4008's efficacy as a tumor-agnostic treatment.

“Based on the prognosis of the patients enrolled so far, we believe RLY-4008 has a strong potential as a tumor-agnostic drug, prompting us to recruit more patients,” Elevar CEO Chong Sae-ho said.

“The approval of Rivoceranib as a liver cancer treatment is expected this year, and we are preparing for an NDA for the bile duct cancer treatment this year, reaching a landmark for both the company and patients.”