Avistone Reveals Findings from Two Clinical Research Programs at 2024 ASCO Annual Meeting

Beijing Avistone Biotechnology Co., Ltd., a pioneering company in precision oncology therapeutics, unveiled promising results from its presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, IL. The presentations focused on the efficacy and safety of their drug vebreltinib in treating specific cancer mutations.

Oral Presentation: Vebreltinib for Glioblastoma

The first presentation, led by Dr. Zhaoshi Bao from Beijing Tiantan Hospital, centered on a randomized, multicenter, open-label Phase II/III trial assessing vebreltinib in patients with previously treated, secondary glioblastoma (GBM) or IDH-mutant GBM harboring the PTPRZ1-MET fusion gene (FUGEN). Gliomas with IDH mutations have a high rate of progressing from low-grade to high-grade within ten years, making effective treatments crucial yet scarce.

In this study, 84 patients were randomized to receive either 300 mg of vebreltinib twice daily or a chemotherapy regimen chosen by the investigator. The chemotherapy options included temozolomide or a combination of cis-platinum and etoposide, administered in 28-day cycles. The trial's primary endpoint was overall survival (OS), with secondary endpoints being progression-free survival (PFS) and objective response rate (ORR).

After a median follow-up of 4.44 months, results revealed that the median OS for the vebreltinib group was 6.31 months compared to 3.38 months for the chemotherapy group. The hazard ratio (HR) for OS stood at 0.52, indicating a statistically significant improvement. Median PFS was 1.87 months for the vebreltinib group versus 1.05 months for chemotherapy, with an HR of 0.54. ORR differences between the groups were not significant, at 9.5% for vebreltinib and 2.6% for chemotherapy.

Grade 3 or 4 treatment-related adverse events were lower in the vebreltinib group (7%) compared to the chemotherapy group (12.2%), and no treatment-related deaths occurred. These findings suggest vebreltinib as a potential new targeted therapy for patients with PTPRZ1-MET fusion gene-positive secondary glioblastoma or IDH-mutant glioblastoma, offering a new therapeutic pathway for high-grade gliomas.

Poster Presentation: Vebreltinib for Advanced NSCLC

The second presentation, delivered by Dr. Jin-Ji Yang from the Guangdong Lung Cancer Institute, focused on the efficacy and safety of vebreltinib in patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. This mutation is present in about 3-4% of NSCLC cases and is linked to poorer survival rates. Vebreltinib, a potent and highly selective c-MET inhibitor, previously showed superior ORR benefits in this patient population.

This Phase II study involved 52 patients who received 200 mg of vebreltinib twice daily until they met discontinuation criteria. Tumor tissue was analyzed for MET exon 14 skipping mutations via next-generation sequencing (NGS). The primary endpoint was ORR as assessed by a blinded independent review committee (BIRC).

With a median follow-up of 19.1 months, the BIRC-assessed ORR was 75%, the disease control rate (DCR) was 96.2%, and the median duration of response (DoR) was 16.5 months. Further, the median progression-free survival (PFS) was 14.3 months, and the median overall survival (OS) was 20.3 months, with a 3-year OS rate of 35.1%. Subgroup analysis showed varying ORRs based on baseline characteristics like brain and liver metastases and age.

Common treatment-related adverse events included peripheral edema, hypoalbuminemia, hypoproteinemia, and anemia. The study underscored vebreltinib’s potential as a leading treatment for MET exon 14 skipping mutation NSCLC.

About Avistone Biotechnology

Avistone Biotechnology is a forward-thinking company focused on developing innovative therapies for significant unmet medical needs, particularly in non-small cell lung cancer (NSCLC) and other solid tumors. The company's portfolio and pipeline highlight their commitment to advancing targeted cancer therapies globally.

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