Avistone Announces Phase II Results for Vebreltinib, a c-Met Tyrosine Kinase Inhibitor (TKI) at the European Society for Clinical Oncology (ESMO) Congress

On October 23, 2023 Avistone Biotechnology Co., Ltd. ("Avistone" or "the Company"), a clinical-stage biotechnology company focused on precision oncology therapeutics, reported preliminary results of the Phase II KUNPENG study of Vebreltinib in Patients (Pts) with advanced Non-small cell lung cancer (NSCLC) Harboring MET (mesenchymal-epithelial transition factor) alterations (Poster# 1379P) at the European Society for Clinical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Madrid, Spain (Press release, Avistone Pharmaceuticals, OCT 23, 2023, View Source [SID1234636284]).

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MET signaling is implicated in cell proliferation, migration, invasion, and survival. Genomic alterations in MET can manifest in driving oncogenesis in the form of MET exon 14 skipping mutations (METex14) or other activating mutations, MET gene amplification, gene fusion and MET protein overexpression. METex14 is an independent prognostic factor associated with poorer survival rates in patients with NSCLC. Avistone is developing Vebreltinib (also referred to as PLB1001, Bozitinib) to treat NSLCLC patients with MET exon 14 skipping alternations and in other potential indications in China.

As of August 9, 2022, 113 patients were enrolled in the China study, among whom 52 patients had METex14 skipping mutations (Cohort 1). Per the blinded independent review committee (BIRC), the primary endpoint of objective response rate (ORR) was 75% (95% CI: 61.1%-86.0%), with 39 participants achieving a complete response (CR) or partial response (PR). The treatment-naïve and previously treated patients displayed an ORR of 77.1% (95% CI, 59.9%-89.6%) and 70.6% (95% CI,44.0%-89.7%), respectively. The median progression free survival (PFS) was 14.1 months (95% CI, 6.4-17.9) and the median overall survival (OS) was 20.7 months (95% CI, 16.2-NE). Most of the TRAEs were grade 1/2.

"We are proud and excited to share data for Vebreltinib at this year’s ESMO (Free ESMO Whitepaper) Congress which has best-in-class potential for patients with MET aberrations in NSCLC," said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone.

Electronic copies of the poster presented at the ESMO (Free ESMO Whitepaper) Congress are available upon request.