FDA accepts New Drug Application for mezigdomide combination regimen in RRMM
The US Food and Drug Administration accepted a New Drug Application for mezigdomide, a novel oral cereblon E3 ligase modulator, in combination with carfilzomib-dexamethasone (Kd), for treating patients with relapsed/refractory multiple myeloma (RRMM) who received ≥1 prior treatment. The application is supported by the significant progression-free survival benefit with mezigdomide-Kd over Kd in the phase 3 SUCCESSOR-2 trial, published recently in The Lancet. The FDA has assigned a Prescription Drug User Fee Act date of May 13, 2027, for this application, according to a press release.

Survival outcomes are comparable with continuous vs fixed-duration maintenance
In the phase 3 ENDURANCE randomized trial that included 516 patients newly diagnosed with standard-risk multiple myeloma (MM) who were not undergoing autologous stem cell transplant, overall survival (OS) was comparable between groups that received indefinite vs fixed-duration lenalidomide maintenance. The analysis, published in the New England Journal of Medicine along with an accompanying Editorial, showed 7-year OS rates of 68.6% and 69% with continuous and two-year lenalidomide maintenance approaches.

Tumor microenvironment “ecotypes” identified via single-cell sequencing
Using single-cell sequencing-based analyses of bone marrow samples from 235 patients with myeloma precursor conditions, newly diagnosed disease, or RRMM, researchers identified distinct subtypes of tumor immune microenvironment, or “ecotypes.” The report, published in Blood, outlines five ecotypes with features associated with limited immune infiltration, immune surveillance, cytotoxic T-cell activity, inflammation, or immune cell stress.

Additional genomic features may help improve MM risk prognostication
An analysis of genomics-based risk factors in patients with newly diagnosed MM in the CoMMpass dataset showed that factors, especially the EMC92/SKY92 92-gene expression signature, improved risk prognostication when combined with the IMS-IMWG high-risk criteria. The study, published in Haematologica, also examined functional high-risk myeloma (FHR). FHR and ultra high-risk MM were spotlighted recently at the 2026 IMS Genomics Workshop.

Ex vivo immune profiling assay can help predict response to bispecifics
Researchers in Germany developed an ex vivo imaging-based assay for profiling and stratifying the response of MM patient-derived bone marrow mononuclear cells, at single-cell resolution, to teclistamab and talquetamab. This immune profiling approach, reported in Leukemia, helped identify ex vivo response phenotypes that stratified clinical response.

Deep learning model identifies malignant cells in single-cell datasets
Single-cell analyses of MM have yielded remarkable insights into the tumor immune microenvironment at high resolution. A study published in npj precision oncology describes the development of a deep learning-based model that uses single-cell gene expression data to accurately differentiate malignant and non-malignant cells across MM disease stages. Such models can not only clarify cellular identity in large datasets but also help correlate cellular profiles to disease progression, the authors noted.