China greenlights first targeted therapy for NRAS-mutated melanoma

18 Mar 2024
Clinical ResultImmunotherapyPhase 2Drug Approval
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.
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.