GOOD NEWS丨Yeedozencom Helps China's First Independently Developed MEK Inhibitor Tunlametinib Receive NMPA Approval for Marketing
On March 15, 2024, our cooperative client Shanghai KeChow Pharmaceuticals Co., Ltd. received a notification from the NMPA that KeChow's declared Class 1 innovative drug, Tunlametinib, has been approved. The product is indicated for patients with advanced melanoma with NRAS mutations who have failed PD-1/PD-L1 therapy. Warmly congratulations to Shanghai KeChow Pharmaceuticals on the approval of Tunlametinib.
In the process of NDA application of the Tunlametinib, Yeedo worked closely with the KeChow to formulate a targeted pre-NDA communication strategy based on the characteristics of the product, and reached an agreement with the CDE on key issues through communication meetings. At the same time, Yeedo conducted a comprehensive and systematic evaluation of the application materials, and KeChow carried out additional research and improvement in advance according to Yeedo's suggestions, which greatly shortened the time limit of supplementary research, and enabled the Tunlametinib to obtain rapid marketing approval within 13 months. Yeedo provided full technical support and consulting services for this project, which contributed to the rapid and smooth approval of the project.
This approval is based on the results of a single-arm, multicenter pivotal Phase II clinical study designed to evaluate the efficacy and safety of Tunlametinib (HL-085) in the treatment of patients with NRAS-mutated advanced melanoma, which enrolled a total of 100 subjects, and as of February 19, 2023, as assessed by an independent review committee, the confirmed Objective Remission Rate (ORR) in the efficacy analysis set was 34.7% (see Figure 1), with a median Progression-Free Survival (mPFS) of 4.2 months, the one-year OS rate was 57.2%, and an ORR of 39.1% for those who had received prior immunotherapy. The most common grade 3 and higher treatment-related adverse events with Tunlametinib included elevated blood creatine kinase, diarrhea, and edema, and the overall safety profile was manageable and controllable, with no subjects dying because of the study drug during the study.
Tunlametinib moves up the evidence hierarchy for advanced melanoma treatment in the 2023 edition of the CSCO Melanoma Treatment Guidelines.
For patients with advanced cutaneous as well as extremity melanoma (with/without brain metastases) who carry an NRAS mutation, treatment with Tunlametinib (HL-085) is recommended, moving forward from the original second-line class III recommendation to class I;
For patients with unresectable or stage IV mucosal melanoma who carry an NRAS mutation, treatment with Tunlametinib (HL-085) is recommended, which has been moved forward from the original class III recommendation to class I.
Currently, the validation Phase III RCT of Tunlametinib (HL-085) for the treatment of NRAS-mutated advanced melanin is underway, and the pivotal registration and clinical study of Tunlametinib (HL-085) in combination with a BRAF inhibitor for the treatment of metastatic NSCLC and metastatic colorectal cancer with BRAF V600 mutation is also underway. It is believed that with the approval and marketing of Tunlametinib (HL-085), it will surely benefit more patients with solid tumours with RAS and RAF mutations.
