Hanmi Pharmaceutical has initiated patient dosing in a domestic Phase 2 clinical trial of its oral targeted anticancer candidate belvarafenib for the treatment of malignant melanoma.
The company announced that on Feb. 12 it enrolled and dosed the first patient with locally advanced or metastatic melanoma harboring NRAS mutations at a university hospital in South Korea. The milestone comes about one month after receiving investigational new drug (IND) approval from the Ministry of Food and Drug Safety in January.
The multicenter, single-arm Phase 2 study will enroll 45 patients to evaluate the efficacy and safety of belvarafenib in combination with the MEK inhibitor cobimetinib.
Melanoma remains a difficult-to-treat cancer with limited therapeutic options and a high risk of recurrence. NRAS-mutant melanoma, in particular, has a poor prognosis and lacks approved standard treatments globally, representing a significant unmet medical need.
Belvarafenib, discovered and developed by Hanmi, targets RAF and RAS gene mutations within the MAPK signaling pathway, which regulates tumor cell growth and proliferation. Unlike conventional BRAF inhibitors that primarily act on monomers, belvarafenib is designed to selectively inhibit RAF dimers, including BRAF and CRAF, with the aim of overcoming resistance associated with RAF dimer formation.
Hanmi expects that combining belvarafenib with cobimetinib may address the mechanistic limitations of existing BRAF and MEK inhibitor therapies and provide clinical benefits to a broader population of patients with genetic mutations.
CEO Park Jae-hyun said the company remains committed to developing innovative therapies for patients with limited treatment options, adding that belvarafenib has the potential to become a key option in melanoma and other rare or difficult-to-treat cancers.
