Multiple Myeloma

The expert panel discussed the efficacy observed with cilta-cel in patients with relapsed/refractory multiple myeloma.

Data supporting the FDA decision came from the phase 1/2 LINKER-MM1 trial.

89Zr-DFO-daratumumab shows activity in identifying and localizing multiple myeloma, even in FDG-non-avid cases, per new phase 2 data.

The FDA had reduced driving and geographic restrictions to 2 weeks for patients with lymphomas and multiple myeloma receiving liso-cel and ide-cel.

More than 70% of patients achieve an objective response with isatuximab plus pomalidomide and dexamethasone in the phase 2 EAE115 trial.

Efficacy with etentamig was comparable across prespecified subgroups with relapsed/refractory multiple myeloma, suggesting broad therapeutic benefit.

Mezigdomide with dexamethasone and bortezomib or carfilzomib led to a median PFS exceeding 1 year across 3 cohorts in those with relapsed/refractory MM.

Findings from the phase 1b TRIMM-3 trial support the potential activity of PD-1 inhibition in patients with relapsed/refractory multiple myeloma.

The MagnetisMM-6 trial results showed that elranatamab plus daratumumab and lenalidomide yielded an ORR of 97.3% in transplant-ineligible multiple myeloma.

Similar response rates and safety profiles were observed with subcutaenous and intravenous isatuximab in the phase 3 IRAKLIA study.

Low rates of early relapse in both arms of the phase 3 IsKia trial support the efficacy of carfilzomib in this newly diagnosed multiple myeloma setting.

Results of the PREDATOR-MRD trial found that daratumumab could help predict MRD response for patients with multiple myeloma.

The median overall survival with cilta-cel exceeds 5 years among patients with relapsed/refractory multiple myeloma in the CARTITUDE-1 trial.

The 1-year progression-free survival rate for patients in the BCMA/GPRC5D naïve RP2D group was 95.0% and across all dose levels it was 74.1%.

Results from part 1 dose level G of the MagnetisMM-6 trial found elranatamab, daratumumab, and lenalidomide to be safe and manageable in NDMM.

Daratumumab plus KRd improved MRD negativity and PFS vs KRd alone in patients with newly diagnosed multiple myeloma.

Results from the PERSEUS trial support daratumumab plus bortezomib, lenalidomide, and dexamethasone as a standard of care in transplant-eligible NDMM.

Subgroup data from the CEPHEUS trial reinforce daratumumab plus bortezomib, lenalidomide, and dexamethasone as a standard of care in this population.

Subgroup data from CARTITUDE-4 suggest that cilta-cel may overcome the poor prognosis associated with some high-risk features in multiple myeloma.

PFS was improved with belantamab mafodotin triplet for patients with relapsed/refractory multiple myeloma with high-risk cytogenetics.

The safety profile of talquetamab continued to show a lower high-grade infection risk relative to other approved anti-BCMA bispecific antibodies.

At a median time to response of 1 month, isatuximab elicited a median duration of response of 10.3 months in patients with multiple myeloma.

Combination therapies with teclistamab exhibited a superior overall response rate vs teclistamab monotherapy in relapsed/refractory multiple myeloma.

A Chinese phase 2 trial found that anti-GPRC5D CAR T-cell therapy elicited an ORR of 84% in patients with relapsed or refractory multiple myeloma.

The European Commission is expected to approve the belantamab mafodotin combinations for this multiple myeloma population in the third quarter of 2025.

Based on the trial population and end point criteria, ODAC voted for daratumumab and hyaluronidase-fijh injection for SQ use in high-risk smoldering multiple myeloma.

Data from the DREAMM-7 and DREAMM-8 trials support the approval of belantamab mafodotin for patients with relapsed/refractory multiple myeloma in Japan.

A panel of experts discussed their institutions’ practices for administering bispecific antibodies, BCMA or GPRC5D, to patients with multiple myeloma.

The safety profile of daratumumab plus bortezomib, melphalan, and prednisone remained stable at follow-up, and no new safety signals were observed.

CRS and ICANS occurrence were comparable for patients with relapsed/refractory multiple myeloma 75 years and older vs those younger than 75.