bozitinib (APL-101) / Avistone Biotech, Apollomics, LaunXP Biomedical - LARVOL DELTA

Vebreltinib in MET amplification-driven advanced non-small-cell lung cancer (NSCLC): Results from phase II KUNPENG study (ESMO Asia 2025) - P2 | "Vebreltinib has shown efficacy in pts with MET amplification-driven advanced NSCLC who have received prior chemotherapy or are chemotherapy-naïve, even with PD-L1-positive regardless of TPS, with favorable safety profile."

Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Integrative analysis of MET amplification or overexpression using NGS, FISH, and IHC in patients from the KYLIN-1 study (ESMO Asia 2025) - P1/2 | "For MET amplification detection, NGS has a good agreement with FISH especially in NPA, which means NGS causes little false positive results. MET overexpression represents an independent promising biomarker to guide treatment decision in EGFR-mutated NSCLC with acquired MET overexpression. IHC reported MET overexpression could be utilized to identify target patients to receive combination of Andamertinib + Vebreltinib."

Clinical • Next-generation sequencing • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Vebreltinib in MET amplification-driven advanced non-small-cell lung cancer (KUNPENG): a single-arm, multi-cohort, multicentre, phase 2 study. (PubMed, Lancet Oncol) - P2 | "Vebreltinib showed antitumour activity in patients with MET amplification-driven advanced NSCLC who had previously received chemotherapy or were chemotherapy-naive. Further research is needed to validate these findings."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Concise Review of the Approved MET TKIs (Savolitinib, Gumarontinib, Vebreltinib, Tepotinib, Capmatinib) in China for MET Exon 14 Splice Site Mutated (METex14+) NSCLC Circa 2025. (PubMed, Lung Cancer (Auckl)) - P3 | "Splice site mutations around or within exon 14 of MET (METex14+) are rare, but are one of the common actionable driver mutations in elderly patients with non-small cell lung cancer (NSCLC). On June 30, 2025, vebreltinib has been approved for NSCLC with MET amplification while combination of savoltinib and osimertinib has been approved for EGFR+ post EGFR TKINSCLC with MET amplification post EGFR TKI based on the SACHI trial (NCT05015608). We discuss the current unmet clinical need (need to develop Type II MET TKI to overcome acquired resistance MET mutations at D1228 and Y1230) and future optimal treatment approaches."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Open-Label, Randomized Controlled, Exploratory Clinical Study of Vebreltinib Combined with Temozolomide and Bevacizumab in Patients with Recurrent/Progressive Malignant Gliomas without MET Abnormalities (ChiCTR) - P=N/A | N=64 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital, Capital Medical University; Beijing Tiantan Hospital, Capital Medical University

New trial • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor • MET

A Dose Escalation Study of Vebreltinib Combined with Gamma Knife and Osimertinib in Non-Small Cell Lung Cancer Patients with New Intracranial Metastases or Progression of Original Intracranial Metastatic Lesions Accompanied by MET Abnormalities in Intracranial Lesions During Osimertinib Treatment (ChiCTR) - P=N/A | N=9 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital Affiliated to Capital Medical University; Beijing Tiantan Hospital Affiliated to Capital Medical University

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Novel Organoid Model Retaining the Glioma Microenvironment for Personalized Drug Screening and Therapeutic Evaluation (EANO 2025) - "Notably, GlioME accurately predicted patient response to the recently approved MET inhibitor, vebreltinib. In summary, our results demonstrate that GlioME can retain the parental glioma microenvironment in vitro and reliably test various therapeutic drugs. This organoid model provides a reliable in vitro platform for glioma microenvironment-related research and clinical drug screening."

IO biomarker • Brain Cancer • Glioma • Oncology • Solid Tumor

Determination of 13 janus kinase inhibitors in anti-alopecia cosmetics by ultra-high performance liquid chromatography-tandem triple quadrupole composite linear ion trap mass spectrometry (PubMed, Se Pu) - "Anti-alopecia cosmetics are often found to contain illegal additions of prohibited drugs such as minoxidil， finasteride and other substances...An ultra-high performance liquid chromatography-multiple reaction monitoring-information dependent acquisition-enhanced production scanning （UHPLC-MRM-IDA-EPI） method was developed to determine 13 JAK inhibitors in anti-alopecia cosmetics， including baricitinib， tofacitinib， ritlecitinib， peficitinib， abrocitinib， upadacitinib， ivarmacitinib， fedratinib， filgotinib， ruxolitinib， momelotinib， pacritinib and bozitinib...Recoveries of the 13 JAK inhibitors ranged from 94.7% to 102.2% for the water-soluble matrix and from 92.4% to 99.2% for the cream matrix， with relative standard deviations （RSDs） ≤8.8%. This method is characterized by high efficiency， rapidity， accuracy， sensitivity and simplicity， making it a powerful tool for rapid risk screening and simultaneous quantitative analysis of JAK inhibitors in anti-alopecia cosmetics."

Journal • Alopecia • Immunology

Vebreltinib as Neoadjuvant Therapy in Three Cases of MET Exon 14 Skipping Mutation-Positive NSCLC: A Case Series (IASLC-WCLC 2025) - "Our findings suggest that highly sensitive MET-TKI may confer clinical benefits for these patients and the toxicity profile is tolerable. However, tissue adhesion should be noted during surgery."

Clinical • Anemia • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET

A Phase Ib/Ii Study of Vebreltinib Plus Tislelizumab in Patients With MET-Amplified and PD-L1-Positive Locally Advanced or Metastatic NSCLC (IASLC-WCLC 2025) - "Notably, although both patients exhibited low-level MET amplification by NGS, FISH analysis revealed GCN exceeding 10, suggesting that the optimal cut-off for MET amplification merits further investigation. Larger studies are warranted to validate the efficacy and safety of this combined regimen."

Clinical • IO biomarker • Metastases • P1/2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET • PD-L1

Efficacy of Vebreltinib in Advanced NSCLC Patients With MET Exon 14-Skipping: Post-Hoc Analysis of KUNPENG Study (IASLC-WCLC 2025) - "Subgroup analyses showed the ORR of pts with any baseline brain metastases (N=5), treatment-naïve (N=21) and pre-treated (N=25) were 100.0%, 85.7% and 76.0%; mPFS were 6.4, 25.8 and 12.0 months and mOS was 17.9, 44.3 and 20.7 months, respectively. Conclusions : Vebreltinib provided remarkable tumor response for locally advanced or metastatic NSCLC pts with exon 14 skipping, which can translate into long-term survival benefits, especially in treatment-naïve patients."

Clinical • Metastases • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET

Vebreltinib Plus EGFR-TKI in EGFR-Mutated NSCLC With MET Amplification And/Or Overexpression After Failure on EGFR-TKI: A Retrospective Study (IASLC-WCLC 2025) - "The most common dual-target regimen was Furmonertinib plus Vebreltinib (54%), followed by Osimertinib plus Vebreltinib (31%) at study entry. In our study, pts were eligible if MET gene amplification was detected by NGS, without a threshold limit. The manageable adverse events further support its use in clinical practice."

Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET

Bozitinib Combined With Chemotherapy as Radical Treatment for Stage IIA-IIIC MET-Altered Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Vebreltinib for Neoadjuvant in METex 14 Skipping Mutant Stage IIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Vebreltinib for Advanced or Metastatic CCS (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Oncology • Sarcoma • Solid Tumor

Efficacy and safety of Vebreltinib combined with bevacizumab for metastatic non-squamous non-small cell lung cancer harboring MET exon 14 skipping mutations : A single-arm, single-center, phase Ⅱ study (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Intranasal delivery of dodecyl creatine ester alleviates motor deficits and increases dopamine levels in a 6-OHDA rat model of parkinsonism. (PubMed, Front Aging Neurosci) - "Thus, dodecyl creatine ester (DCE), named CBT101, is a prodrug of creatine created for this purpose...Imbalance in dopamine between the two hemispheres was assessed using the amphetamine-induced turning test after 3 weeks and sensorimotor performance using the beam walking test after 4 weeks, with ongoing treatment. Five weeks after 6-OHDA intoxication, daily intranasal DCE treatment improved sensorimotor performance, striatal dopamine concentration, and modulated striatal pro-BDNF/BDNF balance and neurofilament expression both in plasma and in the striatum. These observations highlight DCE's potential as a therapeutic strategy for neurodegenerative diseases characterized by energy deficiency and major mitochondrial dysfunction."

Journal • Preclinical • CNS Disorders • Metabolic Disorders • Movement Disorders • Parkinson's Disease • BDNF

Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Peking University Cancer Hospital & Institute

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A novel organoid model retaining the glioma microenvironment for personalized drug screening and therapeutic evaluation. (PubMed, Bioact Mater) - "Notably, GlioME accurately predicted patient response to the recently approved MET inhibitor, vebreltinib. Thus, this organoid model provides a reliable in vitro platform for glioma microenvironment-related research and clinical drug screening."

Journal • Brain Cancer • Glioma • Oncology • Solid Tumor

Intranasal Administration of Dodecyl Creatine Ester (CBT101) in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Ceres Brain Therapeutics

New P1 trial • CNS Disorders

A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET Amplification. (clinicaltrials.gov) - P3 | N=280 | Recruiting | Sponsor: Beijing Pearl Biotechnology Limited Liability Company | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2025 ➔ Jun 2025

Enrollment open • Trial initiation date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Treatment of a newly diagnosed glioblastoma harboring MET amplification with vebreltinib in combination with radiotherapy: a case report. (PubMed, Discov Oncol) - "Our paper describes the use of vebreltinib in a newly diagnosed glioblastoma patient harboring MET amplification. This successful case study suggests that novel targeted MET inhibitors may provide potential clinical benefits in select cases on the basis of the MET signaling pathway status."

Journal • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MET

Enhancing the Precision and Efficiency of Pulmonary Tumor Detection With Robotic-Assisted 18F-FDG PET/CT-Guided Lung Biopsy: A Case Report. (PubMed, Thorac Cancer) - "Genetic testing identified a MET mutation, leading to targeted therapy with Bozitinib...This case underscores the potential advantages of robotic-assisted 18F-FDG PET/CT-guided lung biopsy in enhancing diagnostic sensitivity and procedural efficiency by precisely targeting metabolically active areas, minimizing needle adjustments, and potentially reducing false-negative results. Broader application in interventional radiology and oncology warrants further investigation."

Journal • Chronic Cough • Cough • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Sarcoma • Solid Tumor • MET

Vebreltinib plus PLB1004 in EGFR-mutated NSCLC with acquired MET amplification or overexpression after failure on EGFR-TKI treatment: A phase Ib/II study. (ASCO 2025) - P1/2 | "Vebreltinib and PLB1004 at RP2D demonstrates notable efficacy and manageable safety in EGFR-mutated NSCLC with METamp or METov after EGFR-TKIs failure. Findings from our phase Ib+II data suggest that NGS reported METamp+ could be utilized to identify target patients to receive combination of PLB1004 + Vebreltinib. Further studies are warranted to confirm these findings."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Avistone Announces Encouraging Results for Vebreltinib plus Andamertinib (PLB1004) in EGFR-mutated NSCLC with MET Amplification or Overexpression at ASCO Annual Meeting 2025 (Businesswire) - P1b/2 | N=156 | KYLIN-1 (NCT06343064) | Sponsor: Avistone Biotechnology Co., Ltd. | "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."

P1/2 data • Non Small Cell Lung Cancer