KeChow Pharma, a prominent pharmaceutical company specializing in developing and commercializing innovative small molecule therapeutics for cancer, has reached a significant achievement. The China National Medical Products Administration (NMPA) has granted approval for tunlametinib (HL-085) to be used in treating patients with advanced melanoma carrying NRAS mutations who have previously undergone PD-1/PD-L1 treatment. This approval marks a breakthrough as the first targeted therapy specifically tailored for this patient group and represents the first product originating from KeChow's internal research and development efforts since its inception.

The new drug application (NDA) for tunlametinib had undergone priority review by the Center for Drug Evaluation (CDE) of the NMPA. Approval was based on the results of a pivotal phase II registrational study conducted across multiple centers involving 100 patients in China (NCT 05217303). Clinical data evaluating tunlametinib's efficacy in China, assessed by an independent radiological review committee according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, showed an overall response rate (ORR) of 35.8%, a median progression-free survival (PFS) of 4.2 months, and a disease control rate (DCR) of 72.6%. Subgroup analysis revealed a notable ORR of 40.6% among patients previously treated with immunotherapy. The most commonly reported treatment-related adverse events (TRAEs) included rash (53%) and dermatitis acneiform (24%), with the predominant grade ≥3 TRAE being increased blood creatine phosphokinase (38.0%), mostly asymptomatic and manageable with dosage adjustments.

Dr. Hongqi Tian, Founder, Chief Executive Officer, and Chairman of KeChow, expressed excitement and pride in achieving this significant milestone. He highlighted tunlametinib's approval as a crucial step forward in providing a novel treatment option for Chinese patients with NRAS-mutated advanced melanoma who have undergone prior PD-1/PD-L1 therapy. Dr. Tian extended gratitude to the clinicians and patients involved in the trials, as well as acknowledging the steadfast support from health authorities. KeChow remains dedicated to swiftly making tunlametinib accessible in China to serve this patient population.

KeChow holds global rights to tunlametinib and has devised a comprehensive clinical development strategy to explore its efficacy as both a monotherapy and in combination with standard-of-care therapies across various cancers, including melanoma, neurofibromatosis type 1-related plexiform neurofibromas, colorectal cancer, and non-small cell lung cancer in China. Dr. Tian emphasized the company's commitment to expanding tunlametinib's potential through establishing partnerships on a global scale.

Melanoma ranks among the most prevalent cutaneous cancers, with approximately 20,000 new diagnoses reported annually in China. NRAS mutations are identified in 10.4-12.6% of melanoma cases in China and 15-25% globally. NRAS-mutated melanoma is characterized by aggressiveness and poor prognosis, yet prior to tunlametinib, no approved targeted therapies were available for this patient subset. Tunlametinib represents a groundbreaking advancement as the first small molecule drug approved for this indication.

Tunlametinib, a MEK inhibitor discovered and developed by KeChow, targets the MAPK/ERK signaling pathway by inhibiting MEK kinase activity, thereby blocking downstream signaling pathways and curbing tumor cell growth and proliferation. This pathway plays a pivotal role in cancer cell proliferation and apoptosis, with aberrant activation implicated in over one-third of all malignancies. Notably, tunlametinib demonstrates stronger target inhibition and enhanced pharmacokinetic properties compared to other approved MEK inhibitors.

This milestone underscores KeChow's commitment to advancing precision oncology and addressing unmet medical needs in cancer treatment, underscoring a promising future for tunlametinib's therapeutic potential on a global scale.

 

Source: prnewswire.com

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