Multiple Myeloma

Results from the phase 3 GMMG HD7 trial support the approval of the isatuximab-based combination in patients with newly diagnosed multiple myeloma.

Phase 3 DREAMM-7 and DREAMM-8 trial results showed that combinations with belantamab mafodotin showed superior efficacy vs standard of care in the disease.

Results from the AQUILA trial led to the approval of subcutaneous daratumumab for patients with smoldering multiple myeloma at risk of developing the disease.

ODAC voted against the favorability of the agent in combination with dexamethasone and pomalidomide or bortezomib in multiple myeloma.

A real-world analysis of teclistamab, elranatamab, and talquetamab showed comparable outcomes in relapsed or refractory multiple myeloma.

Treatment with ISB 2001 demonstrated robust responses across difficult-to-treat multiple myeloma subgroups in the phase 1 TRIgnite-1 study.

Longer follow-up from the phase 3 MIDAS trial may be necessary to evaluate progression-free survival and overall survival.

Busulfan/melphalan elicited higher PFS among patients with ISS stage II or stage III disease, and melphalan-200 improved PFS in ISS stage I disease.

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.

The dual high-affinity binding observed with ISB 2001 may avoid resistance mechanisms reported with other BCMA-targeted therapies.

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.