Hanmi Pharmaceutical enters phase 2 trial for targeted melanoma drug

(Hanmi)

Hanmi Pharmaceutical said on Thursday that it has entered a phase 2 clinical trial in South Korea for its targeted anticancer drug belvarafenib, marking a key step in the development of the country’s first targeted therapy for malignant melanoma.

According to the company, the Ministry of Food and Drug Safety approved the phase 2 investigational new drug application for belvarafenib on Jan. 5.

The phase 2 study is a multicenter, single-arm trial designed to evaluate the efficacy and safety of a combination therapy of belvarafenib and the MEK inhibitor cobimetinib in patients with locally advanced or metastatic melanoma carrying NRAS mutations, a key driver of tumor development.

Melanoma is a rare and intractable cancer with limited treatment options and a high risk of recurrence, with most available therapies currently supplied by overseas pharmaceutical companies. Hanmi said the development of belvarafenib aims to improve the domestic cancer treatment landscape while strengthening competitiveness in the oncology sector, which remains heavily reliant on imports.

Belvarafenib is an oral anticancer drug that inhibits the mitogen-activated protein kinase (MAPK) pathway by targeting RAF and RAS gene mutations involved in tumor cell growth and proliferation. It selectively inhibits RAF dimers.

According to the company, the combination of belvarafenib and cobimetinib overcomes the mechanistic limitations of existing BRAF monomer and MEK inhibitor combination therapies and may offer clinical benefits to a broader population of patients with diverse genetic mutations.

Kim Na-young, senior vice president and head of new product development at Hanmi Pharmaceutical, said the drug is expected to establish itself as a next-generation innovative therapy for rare and hard-to-treat cancers, including melanoma. She added that the company will work closely with healthcarel professionals, patients and regulators to ensure the successful development and commercialization of belvarafenib.

Hanmi plans to accelerate clinical development and pursue early commercialization through close collaboration with clinicians, patients, researchers and regulatory authorities, while also exploring opportunities to expand the drug’s indications to other rare and intractable cancers.

Chief Executive Officer Park Jae-hyun said addressing unmet medical needs in disease areas with limited treatment alternatives is a core mission of pharmaceutical companies, adding that Hanmi will spare no effort to position belvarafenib as an important treatment option for a wide range of cancer patients.

Earlier phase 1 trials involving patients with solid tumors confirmed the safety and preliminary efficacy of the belvarafenib–cobimetinib combination. Notably, the therapy demonstrated significant antitumor activity in patients with NRAS and other mutations, providing a foundation for further clinical development.