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Two Indications of Vebreltinib Included in the China 2024 National Reimbursement Drug List
Author：Avistone
Time：2024-11-28
In the newly released National Reimbursement Drug List (NRDL) for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2024), Vebreltinib, a novel MET inhibitor developed by Pearl Biotechnology, a wholly-owned subsidiary of Avistone has been successfully included. This marks the first time Vebreltinib’s dual indications for both non-small cell lung cancer (NSCLC) and glioblastoma have been incorporated into China’s NRDL.
As a China Category 1 innovative drug, Vebreltinib is a highly selective c-MET inhibitor. It was first approved on November 16, 2023, for the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 skipping mutations. On April 23, 2024, it received approval for adult patients with IDH-mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade glioma harboring the PTPRZ1-MET fusion gene who had failed prior therapies.
On July 27, 2024, the internationally renowned journal, Journal of Clinical Oncology, published the result of KUNPENG Study[1], a multicenter, multi-cohort, open-label Phase II clinical trial led by Professor Yilong Wu’s team of Guangdong Provincial People’s Hospital. The results assessed by BIRC showed that ORR reached 75.0%, mPFS was 14.1 months, mOS was 20.7 months, DCR was 96.2%, mDoR was 15.9 months, mTTR was 1.0 month. And its subgroup analyses showed that MET exon 14 skipping patients with MET amplification, brain metastases, with liver metastases or with those aged ≥75 years, Vebreltinib showed promising efficacy and favorable safety profiles, consistent with the overall population.
Another study of Vebreltinib showed promising results as well. FUGEN study[2], a randomized, controlled, open-label, multicenter Phase II/III trial led by Academician Tao Jiang’s team at Beijing Tiantan Hospital, presented an oral report at the 2024 ASCO Annual Meeting. The study evaluated Vebreltinib in PTPRZ1-MET fusion-positive secondary glioblastoma (sGBM) based on the WHO Classification of Central Nervous System Tumors (4th edition). Key findings included that Vebreltinib treatment group extended mOS from 3.38 months to 6.31 months, with HR value of 0.52. Its subgroup analyses showed that vebreltinib reduced mortality risk across most subgroups, particularly in patients with max lesion diameter at baseline≤3 cm, where OS reached 32.53 months—an 8 times improvement compared with the control group. And the safety profile remained favorable.
For Chinese patients, Vebreltinib’s inclusion in China 2024 NRDL will benefit more NSCLC and glioblastoma patients and enhance the drug’s affordability and accessibility. More patients with NSCLC or glioblastoma will gain opportunities to prolong its life cycle and have a better life.
Reference：
[1] Jin-Ji Yang et al. J Clin Oncol, 2024 Jul 26:JCO2302363.
[2] 2024 ASCO Meeting Abstracts 2003.
