China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an update on its Phase III clinical study for BPI-16350, a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, used in combination with fulvestrant for the treatment of locally advanced or recurrent hormone receptor positive (HR+) HER2-negative metastatic breast cancer in patients previously treated with endocrine therapy. The study revealed that the BPI-16350 + fulvestrant regimen demonstrated a significantly improved median progression-free survival (PFS) compared to the placebo/fulvestrant group, with the PFS results being independently evaluated. The combination therapy also exhibited good safety signals among the trial participants.
In the competitive landscape of CDK4/6 inhibitors in China, US-based Pfizer’s Ibrance (palbociclib), Eli Lilly’s abemaciclib, Swiss giant Novartis’s ribociclib, G1/Simcere’s trilaciclib, and Hengrui Medicine’s dalpiciclib are all commercially available. Betta Pharmaceuticals’ BPI-16350 is an innovative drug candidate that is yet to receive approval in China or internationally.- Flcube.com
