BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)
Shots:
- The P-I/II (BGB-11417-201) trial of sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on sonrotoclax (160 or 320mg, QD), while Part 2 enrolled 103 pts on 320mg QD after ramp-up
- Trial met its 1EP of improved ORR per IRC & showed significant improvements across 2EPs, incl. CR rate, DoR & PFS; data to be presented at future meeting & shared with FDA & other regulatory bodies for potential approval
- Additionally, NDA for sonrotoclax in R/R MCL & R/R CLL/SLL are under review by China’s NMPA for potential accelerated approval, while the P-III (CELESTIAL-RR) trial for MCL is underway with the first patient enrolled in 2025
Ref: Beone Medicine | Image: Beone Medicine | Press Release
Related News:- Royalty Pharma Signs Agreement to Acquire Interest in Amgen’s Imdelltra Royalties from BeOne Medicines for ~$950M
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com