Hanmi Pharmaceutical will begin a domestic phase 2 clinical trial of the targeted anticancer drug "belvarafenib" for melanoma treatment.
Hanmi Pharmaceutical said on the 8th that it received approval for a domestic phase 2 clinical trial plan (IND) for belvarafenib from the Ministery of Food and Drug Safety on the 5th.
The trial will target melanoma patients whose cancer is caused by specific genetic abnormalities. It will test belvarafenib in combination with the anticancer drug cobimetinib in patients with locally advanced or metastatic melanoma who have mutations in the "NRAS" gene associated with tumor growth, assessing treatment efficacy and side effects. Multiple hospitals in Korea will participate, and the study will proceed without a comparator arm, with all participants receiving the same treatment.
Melanoma is considered a cancer with a high risk of recurrence and difficult to treat. In particular, melanoma with NRAS gene mutations lacks a clear standard therapy, limiting the treatment options available to patients. Most therapies currently in use also rely on products from overseas pharmaceutical companies.
Belvarafenib is an oral anticancer drug that blocks pathways that send signals for cancer cells to grow. It suppresses tumor proliferation by preventing the activation process in which proteins inside cancer cells, acting as a "growth switch," bind to each other. While existing therapies block only some signals and therefore lose effectiveness over time, the company said belvarafenib is designed to reduce the likelihood of such resistance.
A company representative said, "In the prior phase 1 trial, we confirmed the safety of the combination therapy in patients with various solid tumors, and in some patient groups we also observed tumor reduction," adding, "Based on this, we have entered phase 2."
Belvarafenib was also selected for the "Guide" productization support program operated by the Ministery of Food and Drug Safety to accelerate the development of innovative new drugs. As a result, it will receive government support throughout the entire process from trial design to approval.
In Korea, belvarafenib is being administered on a limited basis to some NRAS-mutant melanoma patients with no treatment alternatives through treatment-use approval. Hanmi Pharmaceutical plans to use this phase 2 trial to secure evidence on efficacy and safety and to consider ways to broaden its scope of application.