PLB1004, developed by Beijing Avistone Biotechnology Co., Ltd., is a safe, highly selective, and efficient irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) employed in treating non-small-cell-lung-cancer (NSCLC).
On April 9th, 2025, National Medical Products Administration Drug Evaluation Center (CDE) showed that PLB1004 of Beijing Avistone Biotechnology was intended to be included in the breakthrough treatment for patients with locally advanced or METastatic non-small cell lung cancer (NSCLC) who had EGFR mutation, met amplification and/or overexpression after the failure of EGFR-TKI treatment.
The preliminary clinical results of PLB1004 combined with Vebreltinib in the treatment of non-small cell lung cancer patients with EGFR mutations, MET amplification or MET overexpression after EGFR-TKI were announced at the 2024 World Conference on Lung Cancer.
Forty-four patients received Vebreltinib 100mg plus PLB1004 160mg (n=15), Vebreltinib 150mg plus PLB1004 160mg (n=13), Vebreltinib 200mg plus PLB1004 80mg (n=3), or Vebreltinib 150mg plus PLB1004 80mg (n=13) and were included in the overall safety analysis. Among the 44 patients evaluated, 36.4% of patients had brain metastases and 86.4% of patients had previously received a third-generation EGFR-TKI, respectively. Objective responses occurred across all Vebreltinib and PLB1004 dose levels tested, with partial responses (PRs) observed in 19/32 (59.4%) response-evaluable patients. Among patients with brain metastases, the ORR was 75.0% (9/12). The ORR was 58.6% (17/29) in patients who received prior third-generation EGFR-TKI. The most common TRAEs were rash and paronychia. No patients discontinued treatment due to TRAEs.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
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Post time: Apr-10-2025