Tunlametinib Wins Approval in China for NRAS+ Advanced Melanoma After PD-1/PD-L1 Therapy
Source: OncLive, March 2024
China’s NMPA has approved tunlametinib for the treatment of patients with NRAS-mutated advanced melanoma after prior anti–PD-1/PD-L1 therapy.
China’s National Medical Products Administration (NMPA) has approved tunlametinib (HL-085) for the treatment of patients with advanced melanoma harboring NRAS mutations who were previously treated with anti–PD-1/PD-L1 therapy.
The approval was supported by data from a single-arm phase 2 trial (NCT05217303), which demonstrated that evaluable patients with NRAS-mutated disease treated with the MEK inhibitor (n = 95) experienced an independent radiological review committee (IRRC)–assessed objective response rate (ORR) of 35.8% per RECIST v1.1 criteria. Furthermore, the disease control rate (DCR) was 72.6%, and the median duration of response (DOR) was 6.1 months.
Tunlametinib elicited a median progression-free survival (PFS) of 4.2 months and a median overall survival (OS) of 13.7 months.