Novel Monoclonal Antibody Under Study in Resistant Multiple Myeloma
Posted: Thursday, July 25, 2019
According to research presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8012), the humanized monoclonal antibody BION-1301 appears to be safe in patients with relapsed or refractory multiple myeloma. The first-in-class monotherapy targets APRIL, a proliferation-inducing ligand; elevated serum levels of APRIL are correlated with malignancy and resistance to chemotherapy and immunotherapy.
“BION … was well tolerated and dose dependently reduces serum levels of [free] APRIL,” concluded William Bensinger, MD, of the Fred Hutchinson Cancer Research Center in Seattle, and colleagues.
The study included 15 patients with multiple myeloma who had experienced disease progression following at least three systemic treatments and who were either fully active or ambulatory and able to perform light work. Participants were assigned to receive 50 mg, 150 mg, 450 mg, or 1,350 mg of BION-1301 intravenously every 2 weeks. Patients spent a median time on treatment of 2 months and received a median of three doses. Increasing doses of BION-1301 were correlated with a decrease in free APRIL in both serum and bone marrow. The target engagement was 95% achieved at a dose of 450 mg.
A total of eight patients (36%) experienced treatment-emergent adverse events, with the most common being anemia, arthralgia, and dysgeusia, and one patient experienced grade 3 wheezing during the fourth round of treatment. No reported toxicities limited treatment. Overall, 5 of the 14 evaluable patients (36%) for response had stable disease. No objective response was observed.
According to the investigators, “The study is ongoing with patients exposed to higher and/or more frequent doses with the objective of achieving accelerated and sustained APRIL [total engagement].”
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
