by Tom Wilemon
Elranatamab, a novel immunotherapy, demonstrated robust effectiveness in treating relapsed or refractory multiple myeloma in patients according to clinical trial results that Bhagirathbhai Dholaria, MBBS, presented Friday, Sept. 10, during the 18th International Myeloma Workshop.
“Outcomes of patients with relapsed or refractory multiple myeloma are poor and novel therapies are urgently needed,” said Dholaria, assistant professor of Medicine at Vanderbilt University Medical Center. “Elranatamab is a B cell maturation antigen (BCMA) targeted CD3-engaging bispecific molecule developed by Pfizer. BCMA is universally expressed in multiple myeloma with minimal expression on normal tissue, which makes it an ideal target. In this phase 1 study, elranatamab was given at different dose levels to patients with relapsed or refectory multiple myeloma. Many of these patients have failed most of currently FDA-approved myeloma therapies, including stem cell transplantation.”
Elranatamab achieved a confirmed overall response rate of 83% at recommended phase 2 dose. The median time for patient response to the treatment, which is administered as a subcutaneous injection, was 22 days. The data from the study (NCT03269136) also showed that the drug had a manageable safety profile.
“The drug was relatively safe with no dose limiting toxicities during initial dose-escalation period. Low grade (grade 1 or 2) cytokine release syndrome was seen in the majority of patients during first cycle of treatment. Responses were seen even in patients who had previously failed other BCMA-directed therapies. Four patients who were evaluable were negative for measurable residual disease. Further studies are ongoing to evaluate elranatamab as monotherapy and in combination with other drugs,” Dholaria said.
Vanderbilt-Ingram Cancer Center (VICC) was one of the top accruing sites for this clinical trial, where Dholaria is the principal investigator.
Elranatamab is a bispecific antibody that binds to a protein on the surface of multiple myeloma cells and simultaneously activates a receptor found on the surface of cancer-fighting T-cells. It elicits a two-armed immune response. The U.S. Food and Drug Administration has granted elranatamab fast track designation to expedite its review because of its potential to address an unmet medical need.
Dholaria reported the results in Vienna, Austria, at the conference, which is an event of the International Myeloma Society.
For more information about this clinical trial and others at VICC, call 1-800-811-8480.
