KeChow Pharma announced the release of efficacy and safety data for its MEK inhibitor, Tunlametinib, targeting patients with advanced NRAS-mutant melanoma. The data was presented as a poster discussion at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago, U.S., from June 2 to 6. The findings are derived from a multi-center, open-label, single-arm, Phase II pivotal registration clinical study. 

The poster announcement details are as follows:

NRAS-mutant melanoma is a highly malignant cancer with a poor prognosis and limited effective treatment options. Currently, no targeted drugs have been approved globally, underscoring the urgent need for effective therapeutic developments.

In this study, 100 patients with advanced NRAS-mutant melanoma received Tunlametinib at a dosage of 12 mg, administered orally twice daily. Of these, 95 patients were included in the efficacy analysis, showing an objective response rate (ORR) of 34.7% as confirmed by an independent imaging evaluation committee. The median progression-free survival (PFS) was 4.2 months, and the disease control rate (DCR) was 72.6%. Notably, the ORR reached 39.1% among patients who had previously undergone immunotherapy. The safety analysis included all patients and demonstrated that Tunlametinib was safe and well-tolerated, with no unexpected adverse events or study drug-related fatalities reported.

About KeChow Pharma

KeChow Pharma is dedicated to developing innovative treatments for tumors, free radical-related diseases, and other therapeutic areas. Its pipeline includes MEK inhibitor, chemoprotective agents, KRASG12C inhibitor, pan-RAF inhibitor, and multiple other tumor-targeted inhibitors. Notably, its MEK inhibitor, Tunlametinib (HL-085), has submitted a new drug application in China and is included in the CSCO guidelines. Another novel drug, a chemoprotective agent, demonstrates superior efficacy and safety compared to current clinical counterparts. All research efforts aim to address unmet clinical needs globally and within China by developing original small molecule drugs with “best-in-class” potential, bridging domestic gaps and fulfilling scientific aspirations to enhance quality of life.