Deepu Madduri, MD

Deepu Madduri, MD, assistant professor of medicine, hematology and medical oncology and assistant professor of urology at Mount Sinai, discusses the safety findings from a first-in-human phase 1 study (NCT03761108) of REGN5458, a BCMA x CD3 bispecific monoclonal antibody, as treatment of patients with relapsed/refractory multiple myeloma.

Cytokine release syndrome (CRS) and cytopenias are a big concern with bispecifics, says Madduri. Most grade 3 or higher toxicities observed in this trial were hematological, as expected, but the infection rate of grade 3 or higher was only 18%. The median time to onset of CRS was about 18 hours, but this event only occurred in 19 of the 49 patients. All cases of CRS were grade 1/2, and no grade 3 or higher CRS were observed.

According to Madduri, there was no relationship observed between the dose and CRS, nor CRS and response.

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Deepu Madduri, MD, discusses the safety findings from a first-in-human phase 1 study of REGN5458, a BCMA x CD3 bispecific monoclonal antibody, as treatment of patients with relapsed/refractory multiple myeloma.

Safety Findings Appear Encouraging for REGN5458 in Relapsed/Refractory Myeloma

Deepu Madduri, MD, assistant professor of medicine, hematology and medical oncology and assistant professor of urology at Mount Sinai, discusses how chimeric antigen receptor (CAR) T-cell therapy is used for patients with multiple myeloma.

CAR T-cell therapy, bispecific agents, and antibody-drug conjugates are the current treatment options available for the relapsed/refractory multiple myeloma population. However, CAR T-cell therapy is typically reserved for patients who are younger and more fit, who do not have rapidly progressing disease. The bispecific agents are used mostly in elderly patients with many comorbidities and cannot handle cytokine release syndrome. Patients with rapid progression cannot wait the 4 to 5 weeks it takes to manufacture their cells for CAR-T cell therapy, says Madduri.

There are different roles for CAR T-cell therapy compared with bispecific therapy. Madduri feels it is important to keep in mind that multiple myeloma is an incurable disease for these patients, so the field does need all these therapies to treat at different points. The question is how to sequence them so patients achieve the best progression-free survival they can.

Deepu Madduri, MD, discusses how chimeric antigen receptor T-cell therapy is used for patients with multiple myeloma.

Addressing the Role of CAR T-Cell Therapy in Multiple Myeloma

Deepu Madduri, MD, assistant professor at Mount Sinai Hospital, discusses the biggest challenge oncologists currently face since the introduction of novel agents to the field of multiple myeloma.

At the start of her practice, lenalidomide (Revlimid) and bortezomib (Velcade) were the only 2 novel agents available for patients with myeloma. Now, there are monoclonal antibodies, checkpoint inhibitors, CAR T cells, and many more.

With so many novel and targeted agents appearing in the treatment landscape, it is hard to keep up with all of the latest data for these drugs. In most cases, there is still not enough information available on the overall survival or progression-free survival with these drugs, Madduri says.

Deepu Madduri, MD, assistant professor at Mount Sinai Hospital, discusses the biggest challenge oncologists currently face since the introduction of novel agents to the field of multiple myeloma.&nbsp;

Deepu Madduri, MD | Authors

Articles

Safety Findings Appear Encouraging for REGN5458 in Relapsed/Refractory Myeloma

Addressing the Role of CAR T-Cell Therapy in Multiple Myeloma

Challenges Seen With Novel Agents in Multiple Myeloma