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FDA Issues Guidance on MRD, CR Outcomes for Multiple Myeloma Approvals

Zevor-Cel Shows Long-Term Efficacy in Small R/R Multiple Myeloma Population
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Clearance of the investigational new drug application allows investigators to expand their assessment of KLN-1010 as part of the phase 1 inMMyCAR trial.

Data from the IZALCO trial support the use of subcutaneous on-body injector administration of an isatuximab-based regimen in relapsed/refractory multiple myeloma.

C. Ola Landgren, MD, PhD, and Noopur Raje, MD, discussed results from the ADVANCE trial of DKRd in patients with newly diagnosed multiple myeloma.

Data from a phase 1 trial may support additional clinical studies of CT0596 in relapsed/refractory multiple myeloma.

Patients 70 years and older with newly diagnosed multiple myeloma experienced higher response rates and prolonged survival with Isa-Rd vs Rd alone.

Based on phase 1 data, GC012F/AZD0120 may broaden therapeutic options for patients with newly diagnosed multiple myeloma.

The decision is based on results from the phase 3 MajesTEC-3 trial, which showed a PFS benefit with the teclistamab combination in patients with pretreated multiple myeloma.

Alan Pliskin and Mary Kay Yamamoto discuss their journey through multiple myeloma treatment, emphasizing the importance of knowledge, positivity, and quality of life.

The median OS among patients with triple-class–exposed relapsed/refractory multiple myeloma with or without EMD was 12.6 months vs 36.4 months.

The 6- and 12-month PFS rates were 76.4% and 68.2%, respectively, in patients with relapsed/refractory multiple myeloma who discontinued treatment with teclistamab early.

Most CRS events were low grade with elranatamab plus daratumumab and lenalidomide without prophylactic tocilizumab in patients with multiple myeloma.

Data from the phase 1b MonumenTAL-2 study support continued investigation of talquetamab/pomalidomide in the phase 3 MonumenTAL-6 trial.

Belantamab mafodotin plus pomalidomide and dexamethasone led to a median PFS of 32.6 months in patients with relapsed/refractory multiple myeloma.

Of the 4 patients with relapsed/refractory multiple myeloma who received KLN-1010, 1 complete response and 3 partial responses were achieved at varying levels of MRD sensitivity.

Phase 2 data support further evaluation of frontline BCMA/CD3 bispecific antibody combinations in phase 3 trials.

After a median follow-up of 3.9 months, AZD0120 elicited an overall response rate of 96% among 23 patients with relapsed/refractory multiple myeloma.

Linvoseltamab monotherapy achieved minimal residual disease negativity in 95% of patients with newly diagnosed multiple myeloma.

Talquetamab plus teclistamab led to an ORR and CR or better rate of 79% and 53%, respectively, in multiple myeloma with true extramedullary disease.

Results from the CAMMA 3 trial showed that subcutaneous cevostamab achieved a 52.0% ORR in BCMA-naive relapsed or refractory multiple myeloma.

Experts at the 2025 IMS Annual Meeting discussed bispecific antibodies as treatment for multiple myeloma, highlighting various treatment strategies and real-world data insights.

Gintemetostat plasma concentrations increased with dosing across all 9 dose levels tested in a phase 1 study.

Results from the MagnetisMM-30 trial showed early ORR data with elranatamab/iberdomide in R/R multiple myeloma.

Outcomes were comparable in the transplant-ineligible population, with KRd and VRd producing identical progression or death rates of 30%.

The 2.5 year progression-free survival rate was 80.5% with cilta-cel for this population, suggesting a potential cure fraction.

Giving cilta-cel in earlier lines of therapy leverages stronger baseline immune health and a more favorable TME to deliver enhanced clinical outcomes.















































