HLB said Thursday it has obtained approval from the U.S. Food and Drug Administration to conduct the phase-2 trial of rivoceranib to treat adenoid cystic carcinoma (ACC). HLB’s subsidiary LSK BioPharma (LSKB) is the developer of the investigational drug.
The phase-2 study will be an open-label and multi-center trial evaluating rivoceranib’s efficacy and safety as a monotherapy in 55 patients with recurrent or metastatic ACC.
ACC is a malignant and highly metastatic tumor that occurs mainly in the salivary glands. Although its growth is slow, it has a high recurrence rate (over 40 percent after the initial treatment) and a low cure rate due to its aggressiveness. If it relapses or spreads after surgery or radiation therapy, the patient should receive chemotherapy.
Chemotherapies include the combination of doxorubicin, cisplatin, and cyclophosphamide. However, there is no standard chemotherapy for ACC.
“As there is no standard chemotherapy for ACC, we aim to secure rivoceranib’s efficacy and safety through the phase-2 trial and commercialize it through the fast-track review program for orphan drugs,” HLB Chairman Jin Yang-gon said.