Hanmi Pharmaceutical Begins Phase 2 Dosing of New Melanoma Drug "Belvarafenib"

Validating combination therapy with cobimetinib
Targeted inhibition of RAF and RAS mutations

Hanmi Pharmaceutical has begun dosing patients in a domestic Phase 2 clinical trial of belvarafenib, the first oral targeted anticancer drug in Korea for the treatment of melanoma.

Hanmi Pharmaceutical announced on the 19th that on the 12th it enrolled the first patient and completed the first dosing in a Phase 2 clinical trial at a university hospital in Korea, evaluating belvarafenib in patients with locally advanced or metastatic melanoma harboring NRAS gene mutations. The trial began roughly one month after the Ministry of Food and Drug Safety approved the domestic Phase 2 investigational new drug (IND) application for belvarafenib last month.

Abdominal CT image showing lesion changes over time in a clinical trial of combination therapy with belvarafenib and cobimetinib in patients with NRAS-mutant melanoma. Hanmi Pharm

This Phase 2 trial will evaluate the efficacy and safety of the targeted anticancer drug belvarafenib in combination with cobimetinib, a MEK inhibitor that blocks an enzyme involved in cell proliferation, in a total of 45 patients.

Melanoma is a hard-to-treat cancer with limited treatment options and a high risk of recurrence, and most current therapies are supplied by global pharmaceutical companies. In particular, NRAS-mutant melanoma is associated with poor prognosis and has no approved standard therapies in Korea or abroad, making it an area of high unmet medical need. At present, belvarafenib is being administered to a limited number of patients in clinical practice under treatment-use approval.

Belvarafenib, originally developed by Hanmi Pharmaceutical, is an oral targeted anticancer agent that inhibits RAF and RAS gene mutations within the mitogen-activated protein kinase (MAPK) pathway, which is involved in tumor cell growth and proliferation. Unlike conventional BRAF inhibitors, which mainly suppress monomers, belvarafenib is designed to inhibit both BRAF and CRAF dimers, thereby helping to overcome resistance associated with RAF dimer formation.

Hanmi Pharmaceutical expects that the combination therapy of belvarafenib and cobimetinib will overcome the mechanistic limitations of existing regimens that combine BRAF monomer inhibitors with MEK inhibitors, and will provide clinical benefits across a broader range of patients with various genetic mutations.

Park Jaehyun, CEO of Hanmi Pharmaceutical, said, "We will do our utmost to ensure that belvarafenib becomes a key treatment option capable of filling the long-standing therapeutic gap in various rare and hard-to-treat cancers, including melanoma."

This content was produced with the assistance of AI translation services.