First-In-Human Study Of AMG 319, a Highly Selective, Small Molecule Inhibitor Of PI3Kδ, In Adult Patients With Relapsed Or Refractory Lymphoid Malignancies
Lanasa MC, Glenn M, Mato AR, et al.
Key Points:
AMG 319, novel small molecule inhibitor of PI3Kδ, with significant antitumor activity in preclinical models
Safety and preliminary efficacy data in patients with relapsed or refractory CLL or NHL reported in this abstract
AMG 319 well-tolerated at doses up to 400 mg QD with grade 3 hemolytic anemia observed as only DLT
Serious adverse events included colitis, anemia, leukocytosis, infection, and hemolysis
Antitumor activity characterized by significant lymph node regression noted in all 20 patients evaluated for response, including those adverse cytogenetic features
Implications:
Further clinical development of compound warranted given these promising results
View the original abstract on the ASH website.
