Belantamab combination regimen gains nods from UK’s NICE and China’s NMPA
United Kingdom’s National Institute for Health and Care Excellence (NICE) issued a draft guidance recommending belantamab mafodotin, in combination with bortezomib and dexamethasone (BVd), for treating patients with multiple myeloma (RRMM) who have received ≥1 prior therapy. NICE is expected to publish the final guidance later in April. The approval, which expands the use of BVd, is based on updated DREAMM-7 data; there was a 42% reduction in the risk of death at a median follow-up of 39.4 months with BVd, compared to standard-of-care daratumumab-based triplet therapy. These data also supported BVd approval by China’s National Medical Products Administration (NMPA) for the same indication.
FDA issues Fast Track Designation for an oral inhibitor of epigenetic modulators in MM
The US Food and Drug Administration granted Fast Track Designation to OPN-6602, an orally bioavailable inhibitor of epigenetic modulators, for the treatment of patients with RRMM who received ≥4 prior lines of therapy. OPN-6602 inhibits two histone acetyltransferases that regulate transcription — E1A binding protein and cyclic-AMP response element binding protein. An ongoing first-in-human phase 1 trial is investigating OPN-6602 in heavily pre-treated patients with RRMM.
MM preclinical and clinical data to be featured at the AACR Annual Meeting
Several MM-related preclinical and clinical studies will be presented at the 2026 American Association of Cancer Research Annual Meeting, including:
Application of the IMS/IMWG high-risk MM definition to the CoMMpass Study cohort
A phase 1/2 trial of a dual-targeting BCMA/CD19 CAR-T therapy in RRMM
The role of cell-free DNA fragments in stratifying risk of early relapse
A systematic review of models predicting hematologic toxicity after CAR-T therapy
A randomized phase 2 trial of metformin to prevent progression from precursor disease to active MM
Use of appropriate control arms in MM clinical trials needs improvement
As newer, more efficacious treatments enter the MM treatment landscape, the appropriate choice of the control arm for imminent/ongoing clinical trials may need refinement. A study published in Blood Advances highlights gaps in the use of appropriate control arms that reflect contemporary standards of care in MM clinical trials currently enrolling patients in the US. These gaps represent “an opportunity for regulatory reform and increased flexibility in trial design,” the authors concluded.
Remote therapeutic monitoring can mitigate healthcare resource use and cost
Remote therapeutic monitoring, using an electronic patient-reported outcome-based (ePRO) platform, decreased infection-related emergency department visits and hospitalizations among patients receiving treatment for hematologic malignancies across five community clinics. These findings from a retrospective study were published in JCO Oncology Practice.
The International Myeloma Society is a professional, scientific, and medical society established to bring together clinical and experimental scientists involved in the study of myeloma. The purpose of this society is to promote research, education, clinical studies (including diagnosis and treatment), workshops, conferences, and symposia on all aspects of multiple myeloma worldwide.
The IMS is a membership organization comprised of basic research scientists, and clinical investigators in the field along with physicians and other healthcare practitioners.
