Avistone Biotechnology presents positive ASCO 2025 results for dual inhibitor therapy in EGFR-mutated NSCLC
Avistone reveals 50% ORR and 9.9-month PFS for its Vebreltinib–Andamertinib combo in MET-amplified NSCLC at ASCO 2025. Find out what this means for lung cancer care.
Beijing-based Avistone Biotechnology Co., Ltd. presented compelling early clinical data for its combination therapy of Vebreltinib and Andamertinib (PLB1004) at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. The update, drawn from the ongoing KYLIN-1 Phase Ib/II trial, showcased promising results for patients with EGFR-mutated non-small cell lung cancer (NSCLC) who developed resistance via MET amplification or overexpression after EGFR-TKI failure—a major hurdle in targeted lung cancer therapy.
While Avistone Biotechnology is not yet publicly listed, investor attention on China’s emerging biotech sector has surged, especially around ASCO season, where pipeline visibility often shapes licensing deals and pre-IPO narratives. The company’s latest data presentation adds to that buzz, spotlighting the strategic value of dual-pathway inhibition in one of oncology’s most resistant tumor subtypes.
Why Is MET Amplification an Urgent Problem in EGFR-Mutated NSCLC?
Lung cancer remains the leading cause of cancer-related death globally, with NSCLC accounting for around 85% of all cases. Among NSCLC patients, approximately 10–15% in Western populations—and up to 50% in East Asia—harbor EGFR mutations, making them initially responsive to tyrosine kinase inhibitors like gefitinib or osimertinib. However, resistance to EGFR-TKIs inevitably develops. MET amplification or overexpression is among the most prevalent mechanisms behind this acquired resistance, creating an urgent need for combination strategies that can suppress both EGFR-driven and MET-driven oncogenic pathways.
Avistone’s approach with Vebreltinib (a selective c-MET inhibitor) and Andamertinib (an irreversible EGFR-TKI with CNS penetration) directly targets these dual pathways. With this strategy, the company aims to extend treatment durability while addressing metastatic spread, including to the brain—an area where many TKIs struggle to achieve therapeutic concentrations.
What Did the KYLIN-1 Trial Reveal About Efficacy?
In the Phase Ib/II KYLIN-1 trial (NCT06343064), the recommended Phase 2 dose (RP2D) consisted of Vebreltinib 150 mg BID plus Andamertinib 80 mg QD. Among 56 patients treated under this regimen, the confirmed overall response rate (ORR) reached 50.0%, and median progression-free survival (mPFS) clocked in at 9.9 months. These metrics surpass historical benchmarks seen with salvage-line platinum-based doublet chemotherapy.
Notably, among the 19 patients with brain metastases—a notoriously hard-to-treat group—the ORR remained 42.1%, and mPFS was 9.5 months, supporting the preclinical hypothesis of effective blood-brain barrier penetration by Andamertinib.
The data presentation (Abstract #8632) drew significant attention at the ASCO 2025 Poster Session on metastatic NSCLC, as it reinforces the viability of dual-inhibition therapy in a second-line setting after EGFR-TKI resistance.
How Does the Safety Profile Stack Up Against Standard of Care?
The safety outcomes were favorable. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in only 19.6% of patients. No patients discontinued treatment due to TRAEs, and no treatment-related deaths were reported. Importantly, no new safety signals emerged—an encouraging sign in a population that has already endured multiple lines of therapy.
From a regulatory standpoint, this clean safety profile could improve the combination’s standing against platinum-based doublets, which often involve toxicities such as hematological suppression and gastrointestinal distress. If KYLIN-3, the ongoing Phase III trial, reproduces this tolerability data alongside efficacy, Avistone could secure regulatory traction in both China and global markets.
What Is the Competitive Landscape in Dual-Target NSCLC Therapy?
In the broader oncology ecosystem, competition around dual inhibition of EGFR and MET has intensified. AstraZeneca and Roche have both explored MET inhibitor add-ons to osimertinib, with mixed results depending on MET biomarker enrichment. However, most contenders lack either validated CNS activity or favorable toxicity profiles, offering Avistone a narrow but meaningful differentiation point.
Unlike programs that retro-fit MET inhibition after EGFR-TKI resistance emerges, Avistone is positioning its combo as a potentially proactive second-line standard. Moreover, by focusing trials within Asia—where EGFR mutation prevalence is higher and regulatory pathways are faster—the company could leapfrog global competitors in terms of time-to-market.
Where Does Vebreltinib Stand in China’s Regulatory Pipeline?
Vebreltinib is already approved in China for treating NSCLC with MET exon 14 skipping mutations, and gliomas with the PTPRZ1-MET fusion gene. A New Drug Application (NDA) has been submitted to the Chinese Center for Drug Evaluation (CDE) for patients with MET amplification in NSCLC, and the application has been granted priority review.
This regulatory momentum positions Vebreltinib as a foundational anchor in Avistone’s broader pipeline, which is increasingly structured around biomarker-driven oncology targets. If the CDE approves the expanded label, it could set the stage for broader combination use with agents like Andamertinib.
What Are the Financial Implications for Avistone and the Sector?
Although Avistone Biotechnology is private, the company has drawn significant venture interest from cross-border life sciences funds. In China’s broader biotech ecosystem, companies that successfully deliver ASCO data often experience a steep jump in valuation during their next capital raise. Investors are expected to focus on licensing discussions, potential for NDA filing in ex-China markets, and pre-commercial partnering opportunities in regions with high EGFR+ NSCLC prevalence, such as Southeast Asia, Japan, and South Korea.
Sentiment across institutional investor circles tracking emerging markets biotech has been cautiously optimistic following the ASCO data. Analysts note that Avistone’s clean efficacy-safety profile and CNS activity meet a critical need and align with payer trends shifting away from chemotherapy and toward biomarker-based care.
In secondary channels such as WeChat investor groups and biotech forums, enthusiasm is already translating into speculative interest in peer pipeline companies. This trend could further accelerate cross-licensing deals or even pre-IPO M&A conversations among China’s oncology drug developers.
What’s Next for the Vebreltinib–Andamertinib Combination?
The KYLIN-3 trial (NCT06970782), which compares Vebreltinib–Andamertinib to platinum-based doublet chemotherapy in the same molecularly defined NSCLC population, is now underway across multiple centers. If successful, it could cement the duo as a new standard of care in the post-EGFR-TKI treatment sequence.
In parallel, Avistone is expected to explore broader applications of this combination in first-line settings or in patients with less common EGFR mutations like exon 20 insertions, given Andamertinib’s broad target profile. Analysts also speculate that Avistone may explore Western regulatory pathways through Fast Track or Breakthrough Therapy designation if KYLIN-3 meets its endpoints.
With biomarker-guided treatment pathways gaining favor globally, Avistone’s strategy aligns with both clinical and economic imperatives. Should ongoing studies confirm durability of response, CNS control, and tolerability, the company could become a breakout name in targeted NSCLC treatment.
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