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

Efficacy of MET-TKI in ALK-rearranged,MET-aberrant Advanced NSCLC After Resistance to ALK-TKI (IASLC-WCLC 2026) - "Five patients received crizotinib or ensartinib, while 8 patients received alectinib/lorlatinib combined with savolitinib/vebreltinib/capmatinib. Lung cancer drug-sensitive organoids could offer personalized medication guidance. Further research is needed for further exploration in the future."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • MET

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

First-Line Treatment of De Novo MET Amplification With High PD-L1 Expression in NSCLC: A Case Series (IASLC-WCLC 2026) - "The KUNGPENG study established the efficacy of vebreltinib in this setting—leading to its NMPA approval in China, the optimal first-line strategy for patients with concurrent MET amplification and high PD-L1 expression remains unclear...NGS revealed MET copy number gain (CN 6.17), and FISH confirmed clustered amplification.The first-line savolitinib started in July 12, 2024...The first-line chemo-immunotherapy with sintilizumab, nab-paclitaxel, and carboplatin, achieving a PR with a PFS of 8 months...best response is PR with PFS 6m.He received pemetrexed, carboplatin, and pembrolizumab for second-line therapy, achieving a durable PR till now more than 2 years .Case 4: 65-year-old male, heavy smoker...Biomarkers showed high PD-L1 (95%) and MET IHC (95%, 3+), with NGS revealing MET CN 3.8 and MET cluster amplification by FISH.He received first-line pemetrexed, carboplatin, and sintilimab for six cycles and then maintenance with pemetrexed+sintilimab achieving a PR with a..."

Clinical • IO biomarker • Cough • Interstitial Lung Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • MET • PD-L1

Vebreltinib With or Without Chemotherapyas Neoadjuvant Therapy in NSCLC With MET Alterations: A Cohort, Phase II Study (IASLC-WCLC 2026) - P2 | "Conclusions : Vebreltinib-based neoadjuvant treatment for NSCLC pts with MET alterations demonstrated manageable safety profile and encouraging effectiveness for IIIA-IIIB(N2) NSCLC. A Longer follow up and a larger multi-center trial are warranted to further verify the efficacy and safety."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • 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 Prospective, Multicenter Phase Ib/II Study of Vebreltinib Plus Firmonertinib in EGFR-TKI-Refractory c-Met-Amplified NSCLC (IASLC-WCLC 2026) - "Conclusions : This study demonstrates that the combination of vebreltinib and firmonertinib represents a promising therapeutic strategy for patients with EGFR-mutant, c-Met-amplified NSCLC who have progressed after EGFR-TKI failure. The safety profile of this combination regimen was acceptable and manageable."

Clinical • P1/2 data • Leukopenia • Lung Cancer • Non Small Cell Lung Cancer • Pruritus • Solid Tumor • MET

c-MET Overexpression as an Efficacy Predictive Biomarker in MET Amplification-Driven NSCLC: Explore Analyses of KUNPENG Study (IASLC-WCLC 2026) - "IHC testing can serve as an important supplement to FISH testing. Furtherly, in our study, patients with MET FISH polysomy can also benefit from vebreltinib."

Biomarker • Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET

Efficacy and safety of vebreltinib in advanced clear cell sarcoma (VEBrant): A multicenter, phase II study. (ASCO 2026) - P2 | "Targeted therapy by type Ia MET inhibitor crizotinib revealed a disease control rate (DCR) at 69.2% and objective response rate (ORR) at 3.8%. Vebreltinib demonstrated notable antitumor activity for advanced CCS, representing a marked improvement over existing therapeutic options. Attention should be paid to the risk of severe rash, particularly when combined with immunotherapy. Longer follow-up is required to further confirm the efficacy and safety."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Sarcoma • Solid Tumor

Phase 1/2 Study of Vebreltinib (APL-101) in Combination With Osimertinib in Patients With EGFR-mutant Metastatic Non-Small Cell Lung Cancer (IASLC-WCLC 2026) - P1/2 | "Confirmed ORR was 53.3% (95% CI, 26.6 - 78.7), including one complete response and seven partial responses. Clinical trial information: NCT04743505"

Clinical • Combination therapy • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

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

Targeting MET amplification in non-small cell lung cancer: encouraging results with vebreltinib from the phase II KUNPENG study. (PubMed, Transl Lung Cancer Res) - No abstract available

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

VEBrant: a multicenter, phase II study of MET inhibitor vebreltinib combined with PD-1-based immunotherapy in advanced clear cell sarcoma. (PubMed, Future Oncol) - P2 | "Primary endpoint is Objective Response Rate (ORR) by Simon two-stage design. This study will provide evidence for vebreltinib combined with PD-1-based immunotherapy and improve understanding of advanced CCS management.Clinical trial registration: www.clinicaltrials.gov identifier is NCT07153887."

IO biomarker • Journal • P2 data • Oncology • Sarcoma • Solid Tumor • MITF • PD-L1

Individualized therapeutic approaches for relapsed and refractory pediatric ependymoma: A Case Report (ISPNO 2026) - "Based on this target, the patient was treated with bozitinib (a highly selective c-MET inhibitor with high blood-brain barrier penetration) combined with anlotinib (multi-target tyrosine kinase inhibitor). This case suggests that a mechanism-based synergistic targeted combination strategy offers a viable approach to induce tumor regression in refractory pediatric ependymoma. These findings underscore the critical role of molecular profiling in guiding precision medicine."

Case report • Clinical • Ependymoma • Oncology • Pediatrics • Solid Tumor

Drug Interactions of Vebreltinib, a Novel Type I c-Met Inhibitor, Coadministration With Rifampin or Itraconazole in Healthy Participants. (PubMed, Clin Transl Sci) - "In contrast, coadministration with itraconazole led to an increase in the AUC and Cmax of vebreltinib by about 56% and 46%, respectively. Vebreltinib, both alone and in combination with rifampin or itraconazole, was well tolerated in healthy participants."

Journal • Brain Cancer • Glioma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DUAL-THRUST: Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Second Affiliated Hospital of Nanchang University

IO biomarker • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

PTPRZ1–MET fusion and induction of reprogrammed immuno-microenvironment via MET–IFN-β–LGALS9 signaling pathway during IDH-mutant glioma progression. (ASCO 2026) - "Therapeutic efficacy was evaluated in an immunocompetent orthotopic IDH-mutant/ZM fusion GL261 model treated with anti-LGALS9 antibody (RG9-1), the MET inhibitor vebreltinib, or their combination... PTPRZ1–MET fusion defines a recurrent subset of IDH-mutant gliomas with immunosuppressive remodeling. Integrated evidence supports a fusion-associated MET–IFN-β–LGALS9 axis linking tumor-intrinsic interferon signaling to macrophage-mediated immune regulation, providing a rationale for combined MET and LGALS9 targeting."

Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Solid Tumor • IFNB1 • LGALS9 • PTPRZ1

A Study of PLB1001 in Non-small Cell Lung Cancer With c-Met Dysregulation(KUNPENG) (clinicaltrials.gov) - P2 | N=145 | Completed | Sponsor: Beijing Pearl Biotechnology Limited Liability Company | Trial completion date: Dec 2025 ➔ Jun 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Crizotinib or vebreltinib response and resistance in advanced non-small cell lung cancer with MET exon 14 skipping. (PubMed, Discov Oncol) - "While vebreltinib appears clinically advantageous over crizotinib for METex14-mutated NSCLC, the therapeutic benefits did not reach statistical significance in this study. The observed differential response patterns and resistance mechanisms suggest distinct biological behaviors to type Ia and Ib MET TKIs that warrant further investigation. These findings underscore the need for larger prospective studies to validate the potential superiority of vebreltinib and to better characterize the molecular determinants in NSCLC."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • EGFR • MET

ALK-tyrosine kinase inhibitor resistance due to acquired MET amplification in ALK-fusion positive advanced NSCLC effectively treated by lorlatinib-vebreltinib combination: a case report and literature review. (PubMed, Transl Lung Cancer Res) - "Although clinical practice has attempted to combine targeted drugs for MET amplification, such as crizotinib, with first and second-generation ALK-TKIs and observed preliminary efficacy, there is no published research on the combination of third-generation ALK-TKI lorlatinib with new MET inhibitors such as vebreltinib. Our case report first successfully documented the use of third-generation ALK inhibitor (lorlatinib) in combination with novel MET inhibitor (vebreltinib) for the treatment of advanced NSCLC patients with ALK-TKI resistance due to MET amplification, enabling sustained clinical remission. This case highlights the importance of repeat biopsy to identify acquired resistance mechanisms arising from intratumoral heterogeneity in response to targeted therapy, which is critical for making clinical decisions and adjusting treatment plans for patients with NSCLC."

Journal • CNS Disorders • Depression • Dyslipidemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Psychiatry • Solid Tumor • ALK • BRAF • EGFR • MET • NTRK • ROS1

Fused 1H-/2H-Indazole as Bioactive Privileged Scaffolds: Synthetic Strategies and Pharmaceutical Applications. (PubMed, Curr Drug Discov Technol) - "Moreover, it constitutes the structural backbone of several clinically relevant drugs such as Asitinib, Bozitinib, and Entrectinib. These attributes underscore the prominence of indazole as a key framework in contemporary medicinal chemistry and drug discovery. Overall, the article aims to provide a comprehensive understanding of how innovative C-H functionalization strategies have accelerated the design and development of bioactive indazole derivatives for pharmaceutical applications."

Journal • Oncology

Unravelling the human disposition of [14C]-vebreltinib: Faecal recovery of parent drug and a major circulating metabolite defines its mass balance profile. (PubMed, Br J Clin Pharmacol) - "Following oral administration, the predominant radioactive component recovered in faeces was unchanged parent drug. The quantitative metabolic profile confirms significant systemic exposure to the M2 metabolite. These data provide critical insights into the human disposition of vebreltinib, including a MIST assessment, and support its continued clinical development."

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

Vebreltinib plus EGFR-TKI for EGFR-mutated NSCLC with MET-driven resistance: A real-world study of Chinese patients. (PubMed, Lung Cancer) - "Vebreltinib plus an EGFR-TKI demonstrates favorable efficacy and manageable safety in real-world NSCLC patients with MET-driven resistance, with notable intracranial activity. Immunohistochemistry 3 + may serve as a practical predictive biomarker."

Journal • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A clinical trial of Vebreltinib plus Andamertinib in NSCLC with MET overexpression following EGFR-TKI (ChiCTR) - P2 | N=37 | Sponsor: Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University

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

Vebreltinib (APL-101)—a highly specific, CNS-penetrant c-MET inhibitor for treating NSCLC, brain tumors, and other solid tumors with MET dysregulation. (The Manila Times) - "Apollomics is currently conducting the ongoing Phase 2 portion of the global SPARTA study at approximately 25 study sites in over 10 countries in North America, Europe and Asia-Pacific. As of April 2026, over 282 subjects have enrolled in the SPARTA study."

Enrollment status • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Glioblastoma • Hepatocellular Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Thyroid Gland Carcinoma

Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC (clinicaltrials.gov) - P2 | N=19 | Not yet recruiting | Sponsor: Shanghai Chest Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • KRAS • MET • ROS1