China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced the summary report of a Phase II/III study for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) BPI-D0316. The study evaluated the drug as a first-line treatment for naïve locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutation.
Study Design and Results
The multi-center, randomized, open, parallel-controlled Phase II/III study compared the efficacy and safety of BPI-D0316 with icotinib. A total of 362 subjects were enrolled in the trial. The results indicated that BPI-D0316 was more effective than icotinib, with controllable safety profiles. These findings highlight the potential of BPI-D0316 as a first-line treatment option for patients with NSCLC.
Competitive Landscape
AstraZeneca’s Tagrisso (osimertinib), Hansoh Pharma’s almonertinib, and Allist Pharma’s furmonertinib are already commercially available in China and included in the National Reimbursement Drug List (NRDL). Meanwhile, several other third-generation EGFR-TKIs are in the regulatory pipeline, including Aosaikang Pharma’s ASK120067, Betta Pharma’s rezivertinib, and Nanjing Sanhome’s oritinib. Over 30 additional third-generation EGFR-TKIs are currently in clinical stages, indicating a highly competitive market landscape.-Fineline Info & Tech
