In preclinical studies, BGB324 has demonstrated compelling efficacy as a single agent, and in combination with standard of care cancer therapies and checkpoint inhibitors, thereby supporting clinical utility across multiple cancers.
Early clinical studies in healthy volunteers and cancer patients have shown BGB324 to be well-tolerated with a favorable safety profile, and encouraging evidence of single agent and combination activity in AML and NSCLC.
A strong correlation has also been observed with predictive biomarkers and the patients that respond.
BGB324 has received Orphan Drug Designation in the US for AML.
BerGenBio is currently planning Phase 2 studies with BGB324 as a single agent in relapsed acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS); and in combination with erlotinib (Tarceva®) in advanced [EGFR-positive] NSCLC.
The company is also opening Phase 2 studies with BGB324 in combination with KEYTRUDA® (pembrolizumab) in non-small cell adenocarcinoma of the lung and triple negative breast cancer (TNBC) in collaboration with Merck & Co. (Merck Sharp & Dohme outside the United States and Canada).