Hanmi Pharmaceutical(128940) said on the 10th that phase 2 of a domestic clinical trial of the oral targeted anticancer drug "Belvarafenib," which targets NRAS gene mutation melanoma with no available treatments, is proceeding smoothly. The company plans to finish patient enrollment by 2027 and apply for conditional approval in Korea in 2028.
Hanmi Pharmaceutical presented a poster on the phase 2 trial design and study status of Belvarafenib at the 52nd Korean Cancer Association Annual Meeting (KCA 2026), held on the 25th–26th at the Grand Intercontinental Seoul Parnas in Gangnam-gu, Seoul.
Belvarafenib works by selectively inhibiting RAS dimers, a target in the MAPK (mitogen-activated protein kinase) signaling pathway involved in tumor cell growth and proliferation.
Melanoma is a hard-to-treat cancer with a high risk of recurrence and limited treatment options. In particular, NRAS-mutant melanoma is known to be more invasive and more likely to metastasize than general melanoma, with a shorter overall survival, but there is currently no approved standard therapy in Korea or overseas.
In a prior global phase 1 trial, Belvarafenib demonstrated antitumor activity in patients with solid tumors harboring NRAS and BRAF mutations. Based on this, a follow-up trial is underway in Korea in patients with NRAS-mutant locally advanced or metastatic melanoma.
The domestic phase 2 is a multicenter, single-arm study evaluating the efficacy and safety of Belvarafenib in combination with the MEK inhibitor "cobimetinib." The company expects that this combination will complement the limitations of existing BRAF inhibitor plus MEK inhibitor regimens and improve treatment effects in a broader range of patients with genetic mutations.
This trial has been underway at 10 research sites nationwide since the first patient was enrolled in February. Hanmi Pharmaceutical plans to complete enrollment of 45 patients by 2027 and apply for conditional approval to the Ministery of Food and Drug Safety in 2028 based on the clinical results.
Currently, Belvarafenib is being administered on a limited basis to some patients through the expanded access program. It was also selected last year as a task for "Guide," a productization support program for innovative products by the Ministery of Food and Drug Safety. This program, linked to expedited review (GIFT), supports preparation of approval materials and reviews of drafting standards.
Lee Mun-hee, clinical team leader (executive director) at Hanmi Pharmaceutical, said, "Through the phase 2 study of Belvarafenib, we are systematically verifying efficacy and safety in patients with NRAS-mutant melanoma and focusing on securing a treatment option that can address medical unmet needs," and added, "As patient enrollment is ongoing, we hope this will provide a new treatment opportunity for patients with limited options."