China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) BPI-D0316 has been accepted for review by the Center for Drug Evaluation (CDE). The company is seeking approval for BPI-D0316 in first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 (L858R) replacement mutation. This follows a previous filing in March 2021 for the drug’s use in locally advanced or metastatic NSCLC with T790M mutation following resistance to EGFR-TKI, which is currently undergoing technical review.
Clinical Trial Results
The filing is based on the randomized, controlled, multi-center, open Phase II/III study (IBIO-103), which assessed the efficacy and safety of BPI-D0316 (75→100 mg) in patients with locally advanced or metastatic NSCLC with positive EGFR-sensitive mutations who had not received prior systemic treatment (N=362). The study compared BPI-D0316 with icotinib (125 mg). Results showed that the median progression-free survival (PFS) in the BPI-D0316 group was 22.1 months, compared to 13.8 months in the icotinib group (HR 0.49, P<0.001). BPI-D0316 reduced the risk of disease progression or death by 51% compared to icotinib. In patients with baseline brain metastasis, BPI-D0316 reduced the risk of disease progression or death by 52%.
Safety Profile
In terms of safety, treatment-related adverse events (TRAEs) were predominantly grades 1 to 2, with thrombocytopenia being the most common. This safety profile underscores BPI-D0316’s potential as a first-line treatment option for patients with advanced NSCLC, particularly those with EGFR mutations.-Fineline Info & Tech
