Hanmi Pharmaceutical said on the 19th it has enrolled the first patient and completed the first dosing in a phase 2 clinical trial at a domestic university hospital evaluating belvarafenib in patients with locally advanced or metastatic melanoma harboring NRAS mutations.
Belvarafenib received approval for a domestic phase 2 clinical trial protocol (IND) from the Ministery of Food and Drug Safety in January. About a month after approval, dosing of a patient was carried out.
Melanoma is a hard-to-treat cancer with limited treatment options and a high risk of recurrence. In particular, NRAS-mutant melanoma has a poor prognosis, and there is no approved standard therapy domestically or internationally. In current clinical practice, belvarafenib is being administered on a limited basis to some patients through approval for treatment purpose use.
Belvarafenib is an oral targeted anticancer drug candidate that targets and inhibits RAF and RAS gene mutations in the mitogen-activated protein kinase (MAPK) pathway, which is involved in tumor cell growth and proliferation.
This phase 2 trial will evaluate the treatment effect (efficacy) and safety of the combination therapy of the targeted anticancer agent belvarafenib and the MEK inhibitor cobimetinib in a total of 45 patients.
The company said, "The combination therapy of belvarafenib and cobimetinib is assessed as a treatment strategy that can overcome the limitations of existing BRAF monomer and MEK inhibitor combination therapy and provide clinical benefits in a broader population of patients with genetic mutations."