Avistone Announces the Approval of Vebreltinib as the First MET-TKI Treatment for a Rare Brain Glioma Subtype in China
April 25 2024 - 11:12AM
Business Wire
Beijing Avistone Biotechnology Co., Ltd. (also referred to as
Avistone Biotechnology or Avistone), an innovative biotechnology
company focused on precision oncology therapeutics, announced the
approval to expand the use of vebreltinib (also referred to as
PLB1001, APL-101, bozitinib, CBT-101) from the Chinese National
Medical Products Administration (NMPA) for the treatment of adult
patients with isocitrate dehydrogenase (IDH) mutant Astrocytoma
(World Health Organization grade 4) with the PTPRZ1-MET fusion gene
or glioblastoma with a history of low-grade disease who have the
PTPRZ1-MET fusion (ZM fusion) gene and have failed previous
treatments. This supplemental New Drug Application (sNDA) approval
makes vebreltinib the world’s first c-Met inhibitor approved for
treatment of Central Nervous System (CNS) tumor with c-Met
alteration. In November 2023, vebreltinib received conditional
approval for the treatment of metastatic patients with MET Exon14
Skipping non-small cell lung cancer (NSCLC) from the NMPA.
Glioma is a refractory primary malignant intracranial tumor,
accounting for approximately 46% of intracranial tumors [1].
Surgery, radiotherapy and chemotherapy are current standard
treatment strategies for gliomas, and the prognosis is poor. The
5-year overall survival (OS) rate of patients with malignant glioma
is less than 10% [2]. In previous studies in Chinese patients,
about 12% of brain gliomas were found to have MET fusion [3]. Among
the representative type PTPRZ1-MET fusion gene (hereinafter
referred to as ZM fusion) occurs in about 14% of glioblastomas with
a history of lower-grade disease, often co-occurring with MET Exon
14 skipping mutations and is associated with poor prognosis
[3-4].
The approval of vebreltinib for the ZM fusion-positive glioma
indications is based on the positive results of the FUGEN study
(NCT06105619). The FUGEN study is a randomized controlled, open
label, multicenter clinical registration phase II/III study. This
84-patient study compared the efficacy and safety of vebreltinib
with the dose-dense regimen of temozolomide or the combination of
etoposide and cisplatin, with OS as the primary endpoint. The
median OS for the vebreltinib monotherapy regimen was 6.31 months,
compared to 3.38 months for the control group, reducing the risk of
death by 48% and significantly improving the survival of patients
with recurrent relapsing ZM fusion glioma, with an acceptable
safety profile.
"The development of drugs for indications related to MET targets
has always been a difficult one. This is not only a victory for
translational medicine, but also marks the advent of the era of
targeted therapy in the field of brain glioma,” said Dr. Hepeng
Shi, Chairman, CEO, and Founder of Avistone.
About Avistone Biotechnology
Beijing Avistone Biotechnology Co., Ltd. (also referred to as
Avistone Biotechnology or Avistone) is an innovative biotechnology
company focused on developing innovative therapies for patients
with significant unmet medical needs globally. Avistone has an
extensive portfolio and pipeline of targeted therapies in Non-Small
Cell Lung Cancer (NSCLC) and in other solid tumors.
References:
[1] Louis D N. Annu Rev Pathol, 2006, 1: 97-117. [2] Qi Y, et
al. Front Immunol. 2020 Nov 27;11:578877. [3] Guo R, et al. Nat Rev
Clin Oncol. 2020 Sep;17(9):569-587. [4] Hu H, et al. Cell. 2018 Nov
29;175(6):1665-1678.e18.
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David Chung Chief Business Officer
david.chung@avistonebio.com