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

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

An Open-Label, Single-Center, Multi-Cohort, Phase II Study Evaluating the Safety and Efficacy of Vebreltinib-Based Combination Therapy in Previously Treated Patients with Locally Advanced or Metastatic MET-Overexpressing Non-Small Cell Lung Cancer (ChiCTR) - P2 | N=52 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • KRAS • MET • NTRK • RET • ROS1

Antitumor activity of vebreltinib and characterization of clinicogenomic features in solid tumors with MET rearrangements. (PubMed, Cancer Discov) - "Similar to MET exon 14-altered lung cancer, secondary mutations in the kinase domain can confer resistance to MET TKIs in MET fusion-positive cancers. Overall, these data categorize MET rearrangements as actionable targets in solid tumors."

Journal • Biliary Cancer • Cholangiocarcinoma • Hepatology • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN). (clinicaltrials.gov) - P2/3 | N=84 | Active, not recruiting | Sponsor: Beijing Pearl Biotechnology Limited Liability Company | Trial completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=27 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting | Trial completion date: May 2030 ➔ Dec 2029 | Trial primary completion date: Jun 2027 ➔ Jan 2027

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Vebreltinib for Advanced Non-Small Cell Lung Cancer Harboring c-Met Exon 14 Skipping Mutation: A Multicenter, Single-Arm, Phase II KUNPENG Study. (PubMed, J Clin Oncol) - "Vebreltinib has shown promising efficacy and a favorable safety profile in patients with METex14-mutant NSCLC."

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

Vebreltinib effective in MET-amplified NSCLC. (PubMed, Nat Rev Clin Oncol) - No abstract available

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

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

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