Latest Data of Vebreltinib on MET Amplification from the KUNPENG Study Published in The Lancet Oncology

On December 6, 2025, the KUNPENG study — a multicenter, multi-cohort, open-label Phase II clinical trial evaluating Vebreltinib for the treatment of advanced non-small cell lung cancer (NSCLC) patients with MET alterations, spearheaded by the research team led by Professor Wu Yilong from Guangdong Provincial People's Hospital — was published in The Lancet Oncology, an internationally authoritative journal with a latest impact factor (IF) of 35.9. Data from Cohorts 2 and 3 of the study showed that Vebreltinib demonstrated definite clinical benefits and favorable safety profiles in patients with MET-amplified advanced NSCLC.

 01  Clear survival benefit

In the KUNPENG study, a total of 86 patients with locally advanced or metastatic NSCLC harboring MET amplification were enrolled in the MET amplification cohort (Cohort 2 and Cohort 3) [central laboratory-confirmed tissue samples showed EGFR wild-type (wt), ALK rearrangement-negative, ROS1 rearrangement-negative, KRAS mutation-negative status, plus MET amplification with gene copy number (GCN) ≥ 6]. All 86 patients were included in the full analysis set (FAS) and the safety set (SS). As of November 14, 2024, assessments by the Blinded Independent Review Committee (BIRC) demonstrated the following results based on the full analysis set: the overall objective response rate (ORR) was 48.8%, the disease control rate (DCR) was 77.9%, the median duration of response (DoR) was 12.1 months, the median progression-free survival (PFS) was 7.4 months, and the median overall survival (OS) was 13.9 months. In Cohort 2, 33 patients were enrolled, with an ORR of 48.5%, a DCR of 78.8%, a median DoR of 11.0 months, a median PFS of 6.2 months, and a median OS of 11.7 months. In Cohort 3, 53 patients were enrolled, with an ORR of 49.1%, a DCR of 77.4%, a median DoR of 12.1 months, a median PFS of 8.3 months, and a median OS of 15.5 months.

 02  Excellent subgroup data

In the KUNPENG study, as of November 14, 2024, a total of 21 enrolled patients had baseline brain metastases. According to the assessments by the Blinded Independent Review Committee (BIRC), 10 of these patients achieved a confirmed partial response (PR), with an objective response rate (ORR) of 47.6% and a disease control rate (DCR) of 85.7%. The median duration of response (DoR) was 11.0 months, the median progression-free survival (PFS) was 8.3 months, the median overall survival (OS) was 14.7 months, and the 12-month OS rate reached 61.9%. Patients with PD-L1 positivity (regardless of TPS score levels) all derived benefits from monotherapy with Vebreltinib. Notably, in the PD-L1 TPS 1–49% subgroup, the ORR was as high as 75%, and the median PFS reached 13.6 months.

 03  The KUNPENG soars high

Data from the MET amplification cohorts in the KUNPENG study demonstrated that Vebreltinib monotherapy yielded significant clinical benefits for patients with MET-amplified locally advanced or metastatic NSCLC, regardless of whether they were treatment-naïve and/or previously treated, or had brain metastases at baseline. The drug was well-tolerated, with the incidence of grade ≥3 treatment-related adverse events (TRAE) being 31.4% (27 cases). On June 30, 2025, the National Medical Products Administration (NMPA) of China granted conditional approval for Vebreltinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) amplification. Vebreltinib is expected to transform the clinical practice for MET-amplified NSCLC and usher in a new era of precision diagnosis and treatment for this patient population.

Reference

1.Wu Y-L, Yao Y, Yang J-J, et al. Vebreltinib in MET amplification-driven advanced non-small-cell lung cancer (KUNPENG): a single-arm, multi-cohort,multicentre, phase 2 study. Lancet Oncol 2025; published online Dec 6.

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