[ESMO ASIA 2025 Express] Avistone Unveils Groundbreaking Research Findings: New Evidence for Treating MET-Altered NSCLC Patients with EGFR-TKI Resistance

Abstract number：998P

Session：Poster presentation

Principal Investigator：Caicun Zhou (Department of Oncology, Shanghai East Hospital)

Presentation Period：December 5–7, 2025

Venue Location：Room 311

Core Study Results (Data Cut-off: May 30, 2025)
1. High Consistency of MET Detection Results

• Among the 46 patients in the Recommended Phase 2 Dose (RP2D) cohort who underwent all three detection assays (NGS, FISH and IHC), 67.4% achieved concordant positive results; in the 70-patient screening cohort, the concordant positive rate stood at 64.3% (see Poster Figure 2A and 2B for details).
• In the 70-patient screening cohort, the Positive Percent Agreement (PPA) between NGS and FISH was 82.76%, with an Overall Percent Agreement (OPA) of 81.43%; the PPA between IHC and FISH reached 88.33%, and the OPA was 78.67% (see Poster Table 1B for details).

2. Notable Efficacy of the Dual-target Combination Regimen; IHC 3+ Serves as a Potential Biomarker

• In the RP2D cohort (n=56), the Blinded Independent Central Review (BICR)-confirmed Objective Response Rate (ORR) reached 53.6% (95% CI: 39.7–67.0), with a median Progression-Free Survival (mPFS) of 9.5 months (95% CI: 5.6–13.8), demonstrating favorable clinical benefits (see Poster Figure 3 for details).
• The IHC 3+ subgroup (including FISH-negative patients, n=51) exhibited promising efficacy, with an ORR of 59.1% (95% CI: 43.2–73.7) and an mPFS of 8.3 months (95% CI: 5.6–13.8) (see Poster Figure 3 and Table 2 for details).

3. Impressive Intracranial Efficacy Data

• For patients with baseline brain metastases (n=19), the intracranial ORR was 52.6% (95% CI: 28.9–75.6), and the 6-month and 9-month intracranial PFS rates both reached 79.5% (95% CI: 48.1–93.1) (see Poster Table 3 for details).
• In patients with baseline intracranial target lesions (n=5), the intracranial ORR was as high as 80.0% (95% CI: 28.4–99.5), the 6-month intracranial PFS rate was 75.0% (95% CI: 12.8–96.1), and the 9-month intracranial PFS rate was not yet reached (see Poster Table 3 for details).

 02   Andamertinib (PLB-1004) Capsules

Andamertinib (PLB-1004) Capsules is a China-origin innovative drug with global intellectual property rights. As a small-molecule inhibitor targeting the epidermal growth factor receptor (EGFR), it features high selectivity and the ability to penetrate the blood-brain barrier (BBB). Preclinical studies have demonstrated that it can potently and irreversibly target EGFR exon 20 insertions (EGFR ex20ins). In addition, this molecule can effectively target other EGFR mutations including Del19, L858R, and T790M, with high selectivity.
The New Drug Application (NDA) for Andamertinib has been accepted by the National Medical Products Administration (NMPA) of China in May 2025 and was included in the priority review and approval pathway. Its proposed indication is for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after prior platinum-based chemotherapy and/or PD-1/PD-L1 immunotherapy, or are intolerant to such therapies, and have tested positive for epidermal growth factor receptor (EGFR) exon 20 insertions[2].

 03  Vebreltinib Enteric Capsules

Vebreltinib Enteric Capsules was conditionally approved in China in November 2023 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping alterations. It was approved in April 2024 for the treatment of adult patients with isocitrate dehydrogenase (IDH)-mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of lower-grade glioma, who have failed prior therapies and carry the PTPRZ1-MET fusion gene. On June 30, 2025, it obtained conditional approval from the National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) amplification[3].