KeChow Pharma Announces NMPA Approval of Tunlametinib (HL-085) as the First Targeted Therapy for Patients with NRAS Mutated Advanced Melanoma and Previously Treated with PD-1/PD-L1

18 Mar 2024
Drug ApprovalClinical ResultPhase 2Priority ReviewNDA
-- Tunlametinib is poised to be a potential best-in-class MEK inhibitor based on positive data from the pivotal Phase 2 study
SHANGHAI, March 18, 2024 /PRNewswire/ -- KeChow Pharma, a commercial-stage pharmaceutical company focused on developing and commercializing differentiated small molecule therapeutics for cancer, today announced that the China National Medical Products Administration (NMPA) has approved tunlametinib (HL-085) for the treatment of patients with NRAS mutated advanced melanoma who were previously treated with PD-1/PD-L1. This is the first approved targeted therapy for this patient population and the first product originated from KeChow's in-house research and development activities since the company's inception.
The new drug application (NDA) of tunlametinib was previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA. The approval was based on the results of a multicenter, single-arm, phase II, pivotal registrational study which conducted in 100 patients in China (NCT 05217303). Clinical efficacy data of tunlametinib in China, as assessed by independent radiological review committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, include an overall response rate (ORR) of 35.8%, median progression free survival (PFS) of 4.2 months, and disease control rate (DCR) of 72.6%. Subgroup analysis showed that in patients who had previously received immunotherapy, the ORR was 40.6%. The most common treatment-related skin event was rash (53%), followed by dermatitis acneiform (24%). The most common grade ≥3 TRAE in this study was blood creatine phosphokinase increased (38.0%), which was mostly asymptomatic and manageable with dose modification [1].
"We are excited and proud of this major milestone for KeChow. Tunlametinib, approved in China, is the first internally designed and developed molecule by KeChow team ." said Dr. Hongqi Tian, Founder, Chief Executive Officer and Chairman of KeChow. "The approval of tunlametinib is an important milestone to provide new treatment option for Chinese patients with NRAS-mutated advanced melanoma who previously received PD-1/PD-L1. We would like to express our sincere gratitude to the clinicians and patients who participated in our trials, and we thank the health authorities for their strong support. We are committed to making tunlametinib available in China as soon as possible to serve this patient population."
"We own the worldwide rights to tunlametinibKeChow has a comprehensive clinical development plan to evaluate tunlametinib as a monotherapy and in combination with other standard of care therapies to treat multiple cancers including melanoma, neurofibromatosis type 1–related plexiform neurofibromas, colorectal cancer, and non-small cell lung cancer in China," said Dr. Hongqi Tian. "We look forward to expanding the product potential of tunlametinib through establishing partnerships on a worldwide basis."
Melanoma is one of the most common cutaneous cancers. There are an estimated 20,000 newly diagnosed melanoma patients in China each year [2]. NRAS mutations accounted for 10.4~12.6% of melanoma patients in China [3], and 15-25% globally [4-7]. NRAS-mutated melanoma is more aggressive and associated with poorer outcomes [8-11]. There were no approved targeted therapies for patients with NRAS-mutant melanoma. Tunlametinib is the first small molecule drug approved for this indication.
Tunlametinib is a small molecule inhibitor of Mitogen-activated protein kinase kinase (MEK) discovered and developed by KeChow. Tunlametinib targets the Mitogen-activated protein kinase (MAPK)/extracellular regulated protein kinases (ERK) signaling pathway (also known as RAS/RAF/MEK/ERK signaling pathway) by inhibiting the activity of MEK kinase, blocking downstream signaling pathways, inhibiting the growth and proliferation of tumor cell. MAPK/ERK signaling pathway plays a critical role in cancer cell proliferation and apoptosis. Aberrant activation of this signaling pathway has been implicated in more than one-third of all malignancies. Compared to other approved MEK inhibitors, tunlametinib demonstrated stronger target inhibition and improved pharmacokinetic properties.
Shanghai KeChow Pharma, Inc. is a commercial-stage pharmaceutical company focusing on differentiated small molecule therapeutics for cancer. The company was founded by Dr. Hongqi Tian in 2014, and is headquartered in Shanghai Zhangjiang Pharmaceutical Valley. Since its inception, KeChow is committed to accelerate the discovery, development and commercialization of novel small molecule therapeutics through scientific innovation and by leveraging extensive pharmaceutical expertise from the management team. The company has a science driven corporate culture and is specialized in the development of best-in-class innovative therapeutics to address unmet medical needs of patients around the world.
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