Hans Lee, MD, is the director of Myeloma Research at the Sarah Cannon Research Institute

Nisha Joseph, MD, is an associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine

, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, 

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In today’s episode, we spoke with Nisha Joseph, MD, and Hans Lee, MD, about the FDA's accelerated approval of linvoseltamab-gcpt (Lynozyfic) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Joseph is an associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia. Lee is the director of Myeloma Research at the Sarah Cannon Research Institute in Nashville, Tennessee. 

In our conversation, Drs Lee and Joseph discussed the significance of this approval, key data from the pivotal phase 1/2 LINKER-MM1 trial (NCT03761108), and where linvoseltamab fits into the relapsed/refractory myeloma treatment paradigm alongside other approved agents. 

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Podcasts

Drs Lee and Joseph discuss the significance of the FDA approval of linvoseltamab for the treatment of patients with relapsed/refractory multiple myeloma.

FDA Approval Insights: Linvoseltamab in Relapsed/Refractory Multiple Myeloma: With Nisha Joseph, MD; and Hans Lee, MD

Dr Lee on the Rationale for Investigating Linvoseltamab in R/R Multiple Myeloma

Hans Lee, MD, associate professor, director, Multiple Myeloma Clinical Research, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the rationale for the phase 1/2 LINKER-MM1 trial (NCT03761108) of linvoseltamab (REGN5458) in patients with relapsed/refractory multiple myeloma.

, which investigated the BCMA-directed bispecific T-cell antibody linvoseltamab in patients with relapsed/refractory multiple myeloma. BCMA is an important target in relapsed/refractory multiple myeloma, and several studies have demonstrated the efficacy of BCMA-directed immunotherapies in this disease, Lee says.

This updated presentation of the LINKER-MM1 trial is important because it shows mature data with longer follow-up, Lee emphasizes. This presentation was also the first time that independent review committee–adjudicated overall response rate (ORR) data, the trial’s primary end point, were reported, Lee explains. Key secondary end points of this trial included investigator-assessed ORR, duration of response, progression-free survival, minimal residual disease (MRD) status, and overall survival.

At a median follow-up of 8.1 months, linvoseltamab elicited an ORR of 69.2% among 12 patients from the phase 1 portion of the trial and 105 patients from the phase 2 portion of the trial with relapsed/refractory multiple myeloma who received the agent at 200 mg. A total of 59% of patients achieved a very good partial response (VGPR) or better and 39% of patients achieved a complete response (CR) or better. Furthermore, 10% of patients achieved a best response of PR. The median times to PR or better, VGPR or better, and CR or better were 1 month, 2.6 months, and 7.6 months, respectively. Among the 10 patients who had prior exposure to belantamab mafodotin (Blenrep), the ORR was 70%. Among the 37 patients who achieved a CR or stringent CR with available MRD data, 50% were MRD negative at 10

. Fifty percent of patients were still receiving core treatment with linvoseltamab at median follow-up.

Videos

Hans Lee, MD, discusses the rationale for the phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with relapsed/refractory multiple myeloma.

Hans Lee, MD, assistant professor, director, Multiple Myeloma Clinical Research, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the evolving treatment paradigm in relapsed/refractory multiple myeloma.

An increasing number of options have become available for the treatment of patients with relapsed/refractory multiple myeloma, Lee says. Although many of these regimens are reserved for patients with early relapses, more therapies are emerging for use in heavily pretreated patients who experience late relapses, Lee explains.

Additional options allow for tailored treatment selection based on multiple factors, Lee says. Disease characteristics and treatment characteristics, such as known adverse effects associated with a particular regimen, should be considered, Lee explains. Additionally, patient characteristics, such as comorbidities, age, and preference, are important factors to consider during the treatment selection process, Lee concludes. 

Hans Lee, MD, discusses the evolving treatment paradigm in relapsed/refractory multiple myeloma.  



Hans Lee, MD

Articles

FDA Approval Insights: Linvoseltamab in Relapsed/Refractory Multiple Myeloma: With Nisha Joseph, MD; and Hans Lee, MD

Dr Lee on the Rationale for Investigating Linvoseltamab in R/R Multiple Myeloma

Dr. Lee on the Evolving Treatment Paradigm in Relapsed/Refractory Multiple Myeloma