China greenlights first targeted therapy for NRAS-mutated melanoma

2024-03-18

临床结果免疫疗法临床2期上市批准

Chinese biotech KeChow Pharma has secured approval from the country's drug regulator for tunlametinib (HL-085), an oral MEK inhibitor indicated for patients with NRAS-mutated advanced melanoma previously treated with PD-1/PD-L1 immune checkpoint inhibitors.

The company noted Monday that its drug, developed entirely in-house by KeChow, becomes the first approved targeted therapy for this patient population. Melanoma harbouring NRAS mutations represents approximately 10-12% of melanoma patients in China and is characterised by more aggressive disease and poorer outcomes, it added.

The approval was based on positive data from a pivotal single-arm Phase II study involving 100 patients in China. KeChow said the trial demonstrated an overall response rate (ORR) of 35.8%, with median progression-free survival of 4.2 months. In a subset of patients previously treated with immunotherapy, the ORR increased to 40.6%.

Side effects include rash and dermatitis acneiform. The most common Grade ≥3 treatment-related adverse event was increased blood creatine phosphokinase, which occurred at a rate of 38%, and was mostly asymptomatic and manageable with dose modification, according to the company.

KeChow owns worldwide rights to tunlametinib and has a clinical development plan evaluating it, both as a monotherapy and in combination regimens, across multiple cancer types such as melanoma, neurofibromatosis type 1–related plexiform neurofibromas, colorectal cancer, and non-small-cell lung cancer in China, CEO Hongqi Tian said.

The company is also looking to expand the product by "establishing partnerships on a worldwide basis," the executive added.

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