Avistone Announces Encouraging Results for Vebreltinib plus Andamertinib (PLB1004) in EGFR-mutated NSCLC with MET Amplification or Overexpression at ASCO Annual Meeting 2025

Beijing Avistone Biotechnology Co., Ltd (“Avistone”), an innovative biotechnology company focused on precision oncology therapeutics, today announced that the clinical data for Vebreltinib plus Andamertinib (PLB1004), its innovative combination of potent mesenchymal-epithelial transition factor (MET) inhibitor and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has been presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025.

The details of the poster presentation are provided below:

Poster title: Vebreltinib plus Andamertinib (PLB1004) in EGFR-mutated NSCLC with MET Amplification or Overexpression after failure on EGFR-TKIs treatment: phase Ib/II KYLIN-1 study
Abstract Number For Publication: 8632
Session: Poster Session-Lung Cancer- Non-Small Cell Metastatic
Location: Poster Board, 112
Session Date/Time: 5/31/2025 1:30pm-4:30pm CDT

MET amplification or overexpression is the most common “off-target” mechanism that drives resistance to EGFR-TKIs in NSCLC patients. The results from Phase Ib/II KYLIN-1 study (NCT06343064) showed that Vebreltinib plus Andamertinib demonstrated notable efficacy and manageable safety in EGFR-mutated NSCLC patients with MET amplification or overexpression after EGFR-TKIs failure.

Among the 56 patients enrolled at a dose of Vebreltinib 150mg BID plus Andamertinib 80mg QD (RP2D), the confirmed overall response rate (ORR) was 50.0%, and the median progression-free survival (mPFS) was 9.9 months. In 19 patients with brain metastases, ORR was 42.1% and mPFS was 9.5 months. Grade 3 or higher treatment related adverse events (TRAEs) occurred in 19.6% of the patients. None discontinued treatment or died due to TRAEs. No new safety signal was observed.

A multicenter Phase III study, KYLIN-3 study (NCT06970782), is currently ongoing to further evaluate Vebreltinib plus Andamertinib versus platinum-based doublet chemotherapy in patients with EGFR mutations, MET amplification and/or overexpression, locally advanced or metastatic NSCLC following EGFR-TKI failure.

To obtain a copy of the poster, please email Avistone.

About Vebreltinib

Vebreltinib is an orally, potent and selective c-Met inhibitor. Chinese National Medical Products Administration (NMPA) has formally approved the use of Vebreltinib in locally advanced or metastatic NSCLC patients with MET exon 14 skipping mutations, as well as adult patients with isocitrate dehydrogenase mutant astrocytoma with the PTPRZ1-MET fusion gene or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion gene and have failed previous treatments. Currently, Chinese Center for Drug Evaluation (CDE) has formally accepted its New Drug Application (NDA) and granted it priority review, intended for patients with locally advanced or metastatic NSCLC with MET amplification.

About Andamertinib (PLB1004)

Andamertinib (PLB1004) is an oral, potent, irreversible, and selective EGFR-TKI with potent blood-brain barrier penetration and broad tyrosine kinase activity. Preclinical studies have shown that it can effectively and irreversibly target exon 20 insertion. Additionally, it can also potently target classical EGFR mutations, such as Del19, L858R and T790M with a high degree of selectivity.

About Avistone Biotechnology

Beijing Avistone Biotechnology Co., Ltd. (“Avistone”) is an innovative biotechnology company dedicated to precision therapies with significant unmet medical needs for patients worldwide. Avistone maintains an extensive pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and other solid tumors.

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