Sarclisa (isatuximab-irfc) / Sanofi, AbbVie - LARVOL DELTA

First-Year Results of Isatuximab-Iberdomide Maintenance in MRD-Positive Newly Diagnosed Multiple Myeloma Patients Included in the Phase 3 MIDAS Trial (IMS 2026) - P3 | "While daratumumab plus lenalidomide maintenance has shown efficacy in recent studies (PERSEUS, AURIGA), no data are available regarding anti-CD38 combined with a CELMoD in maintenance... MIDAS (NCT04934475) is an ongoing phase 3 trial evaluating an MRD-adapted consolidation and maintenance strategy in TE-NDMM patients treated with six cycles of isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd)... Maintenance with isatuximab plus iberdomide after Isa-KRd induction and single or tandem ASCT is feasible with a manageable safety profile. This combination induced substantial MRD conversion during the first year of maintenance in patients remaining MRD-positive after consolidation. These findings support further evaluation of anti-CD38 plus CELMoD-based maintenance strategies in high-risk NDMM patients."

Clinical • IO biomarker • Minimal residual disease • P3 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia

Double Hit Ultra-High Risk Myeloma Treated With Isa-VRD Plus Cyclophosphamide Induction and Isa-VRD Consolidation: QoL Analysis of the UKMRA RADAR Trial in Newly Diagnosed Transplant Eligible Patients (IMS 2026) - "Introduction: RADAR was designed to evaluate an intensive treatment strategy comprising Isatuximab-VRD- Cyclophosphamide induction, single autologous stem cell transplantation (ASCT), Isa-VRD consolidation, and Isa-R maintenance in patients with double-hit high-risk disease. QoL outcomes observed in patients with double hit high risk disease receiving intensified ASCT-based therapy indicate this approach can deliver meaningful improvements in patient reported outcomes. As patients continue prolonged intensive consolidation and maintenance regimen ongoing longitudinal monitoring will assess if these benefits are maintained in the longer term"

Clinical • Hematological Malignancies • Multiple Myeloma • Transplantation

Comparative Analysis of Isa SC Vrd (ISASOCUT, Weekly Bortezomib) and Isa IV Vrd (IMROZ, Twice-Weekly Bortezomib): 20-Month Follow-Up in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients (IMS 2026) - P=N/A, P3 | "Introduction: Intravenous (IV) isatuximab (Isa) plus bortezomib (V), lenalidomide (R), and dexamethasone (d) is approved for patients (pts) with transplant-ineligible newly diagnosed multiple myeloma (Ti NDMM) based on the phase 3 IMROZ trial (NCT03319667). This comparative analysis at 20 mos of follow-up found comparable efficacy with greater tolerability for Isa SC OBI (QW V) than Isa IV (BIW V) for PN and IRRs. This analysis demonstrated Isa SC OBI as an efficacious and well-tolerated treatment for Ti NDMM pts."

Clinical • Hematological Malignancies • Multiple Myeloma • Plasmacytoma • Transplantation

48-Month Survival Analysis of the BENEFIT Trial, Isatuximab Plus Bortezomib, Lenalidomide, and Dexamethasone for Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients (IMS 2026) - P3 | "The PFS remains not statistically different when restricting analysis to the first 48 months in BENEFIT, but long term PFS modeling suggests that difference is to be expected. These results support the clinically meaningful benefit of the Isa-VRd regimen compared to IsaRd in TI NDMM patients, including HRMM. This data supports Isa-VRd as a new SOC for TI NDMM patients aged of 65 to 79 years."

Clinical • Late-breaking abstract • Hematological Malignancies • Multiple Myeloma • Transplantation

Isa-VRdlite for of Frail and/or Much Older Patients With High Risk Newly Diagnosed Multiple Myeloma Base on Circulating Plasma Cells (clinicaltrials.gov) - P2/3 | N=15 | Not yet recruiting | Sponsor: The Affiliated People's Hospital of Ningbo University | Trial completion date: Dec 2028 ➔ Dec 2030 | Initiation date: Aug 2026 ➔ Jan 2027 | Trial primary completion date: Aug 2028 ➔ Dec 2028

Trial completion date • Trial initiation date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Monoclonal Antibodies and Antibody-Drug Conjugates: Expanding the Therapeutic Arsenal in Multiple Myeloma. (PubMed, Cancer J) - "Furthermore, challenges in the sequencing of treatments have emerged, as novel immunotherapies have also become available in the early relapse setting. This contemporary review examines the evolving role of mAbs and ADCs in MM, addressing both current status and directions for future research in the field."

Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Extrapolated Progression-Free Survival with Belantamab Mafodotin/Lenalidomide/Dexamethasone (Brd) Exceeds 7 Years in Intermediate-Fit and Frail, Transplant-Ineligible, Newly Diagnosed Multiple Myeloma (IMS 2026) - P1/2 | "Anti-CD38-based regimens (daratumumab + lenalidomide + dexamethasone +/− bortezomib [DRd and DVRd]; isatuximab + VRd [IsaVRd]) are SOC for TI-NDMM based on the MAIA, CEPHEUS, and IMROZ trials. Model-predicted mPFS (based on survival extrapolation) of BRd in TI-NDMM (87.6–110.7 months for 1.9 mg/kg-only cohort and 85.5–110.0 months overall) was longer than the reported mPFS for the triplet (DRd: mPFS 61.9 months at 64.5 months mFU) and comparable to that expected for the quadruplets (DVRd: 96–118 months; IsaVRd: 90 months). All pts were intermediate-fit or frail, highlighting the importance of these results in this population with unmet need. Within the analytical limitations (small sample size, small numbers at risk at later timepoints in Kaplan-Meier analyses, and duration of FU), predicted mPFS in the combined cohorts and the 1.9 mg/kg-only cohort was similar, suggesting potential for high efficacy with BRd for TI-NDMM."

Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Transplantation

ISABELA: A phase 2 study of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed/refractory multiple myeloma. (ASCO 2026) - P2 | " ISABELA is an investigator-initiated study (NCT05922501) enrolling up to 50 patients (pts) with RRMM who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor...Prior therapies included pom (59%), bortezomib (82%), carfilzomib (41%), ixazomib (35%), CD38 antibody (59%) [daratumumab, 59%; isa 12%], and auto SCT (24%). Prior exposure to newer therapies included drugs that target BCMA (24%) [teclistamab 6%, elranatamab 18%, CAR T-cells 12%]; GPRC5D (12%) [talquetamab]; and cereblon (29%) [mezigdomide, 29%; cemsidomide, 12%]... This is the first report in RRMM for the combination of belamaf with a CD38 monoclonal antibody. The ISABELA regimen shows promising preliminary activity in RRMM with an ORR of 86% and 16-month PFS of 73%, including quad-class-exposed pts treated with anti-BCMA therapy, with manageable, reversible AEs."

P2 data • Cardiovascular • Hematological Malignancies • Hypertension • Infectious Disease • Multiple Myeloma • Neutropenia • Ophthalmology • Plasmacytoma • Thrombocytopenia • CRBN

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Multiple Myeloma, Version 1.2027 (NCCN)

NCCN guideline • Multiple Myeloma

Selinexor-Based Therapy in Multiple Myeloma: A Case Series Demonstrating Deep Responses in Heavily Pretreated Patients (SOHO 2026) - "Patients had extensive prior exposure to standard and novel antimyeloma therapies, including CyBorD, VRd, bortezomib/dexamethasone, lenalidomide maintenance, pomalidomide-based regimens, daratumumab, isatuximab, carfilzomib, belantamab mafodotin, radiation, autologous hematopoietic stem cell transplantation, and teclistamab. This case series highlights Seli as a clinically relevant and mechanistically novel therapeutic option capable of restoring disease control in heavily pretreated MM. Its activity across medically complex patients supports its role as an effective salvage or response-deepening strategy. CR: complete response; CyBorD: cyclophosphamide, bortezomib, and dexamethasone; MM: multiple myeloma; RR: relapsed/refractory; VRd: bortezomib, lenalidomide, and dexamethasone; XPO1: exportin 1."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology • XPO1

Optimising CD38-Targeted Radioimmunotherapy in Aggressive Lymphoma with Repeated Lutetium-177 Isatuximab and Terbium-161 Benchmarking (EANM 2026) - "This study extends CD38-targeted isatuximab RIT from proof-of-concept imaging and single-dose therapy towards treatment optimisation. Repeated [177Lu]Lu-DFO/ DOTAGA-isatuximab administrations improve durability of tumour control, whereas [161Tb]Tb-DFO/DOTAGA-isatuximab provides stronger antitumour activity with narrower haematological tolerance. Together, these data support an imaging-informed, radionuclide- and schedule-adapted strategy for translating CD38-targeted RIT in aggressive lymphomas."

Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Thrombocytopenia

Evaluation of Patient-Reported Outcomes and Subgroup Analysis with Subcutaneous Isatuximab Delivered via On-Body Injector Compared with Intravenous Delivery from the Phase 3 IRAKLIA Trial (IMS 2026) - P3 | "Introduction: The phase 3 IRAKLIA trial (NCT05405166) assessed isatuximab (Isa) delivered subcutaneously (SC) via an on-body injector (OBI; Isa SC OBI) vs Isa administered intravenously (Isa IV), with pomalidomide and dexamethasone (Pd), in patients (pts) with relapsed/refractory multiple myeloma (RRMM). In satisfied and neutral pt subgroups, more Isa SC OBI pts reported positive experiences vs Isa IV pts. At EOT, pts perceived more benefits than disadvantages with Isa SC OBI than with Isa IV. Our findings support the feasibility of the OBI as a novel method for SC delivery of Isa, in line with results from the overall IRAKLIA cohort."

Clinical • P3 data • Patient reported outcomes • Hematological Malignancies • Multiple Myeloma

Double Hit Ultra-High Risk Myeloma Treated with Isa-Vrdc Induction and Isa-Vrd Consolidation: Sub Analysis of the UKMRA RADAR Trial in Newly Diagnosed Transplant Eligible Patients (IMS 2026) - "Introduction: RADAR was designed to evaluate an intensive treatment strategy with Isatuximab-VRD- Cyclophosphamide induction, single autologous stem cell transplantation (ASCT), Isa-VRD consolidation, and Isa-R maintenance in patients with double-hit high-risk disease according to recent consensus IMS/IMWG 2025 high risk criteria (Avet-Loiseau, JCO 2025). High-risk definition in newly diagnosed myeloma continues to evolve as more effective therapies are incorporated into frontline treatment. Within the ultra-high-risk, or “double-hit”, subgroup, the presence of additional characteristics such as R2-ISS Stage IV and High LDH may identify patients with an even greater unmet need. Ongoing analyses of the full 125 patients recruited in HR v4.0 of the RADAR trial will refine these findings."

Clinical • Hematological Malignancies • Multiple Myeloma • Transplantation

Incidence and Baseline Predictors of Venous Thromboembolism in Isa-VRd and VRd Arms of the Phase 3 IMROZ Trial in Patients with Transplant Ineligible Newly Diagnosed Multiple Myeloma (Ti NDMM) (IMS 2026) - P3 | "Isatuximab plus bortezomib, lenalidomide, and dexamethasone (Isa-VRd) showed improved efficacy and safety vs VRd in the Phase 3 IMROZ trial (NCT03319667; median follow-up: 60 months [mo]) and is approved for Ti NDMM pts. These findings support VTE safety in using IMID-containing quadruplet therapy in NDMM pts, with Isa-VRd associated with lower VTE rates and cumulative incidence vs VRd from induction to 60 mo. Elevated BMI was identified as a potential baseline VTE predictor. These findings support Isa‑VRd as a standard of care in Ti NDMM."

Clinical • P3 data • Cardiovascular • Hematological Malignancies • Multiple Myeloma • Transplantation • Venous Thromboembolism

Review of Nurse and Pharmacist Survey Evidence on an On-Body Injector and Implications for Isatuximab Subcutaneous via the On-Body Injector in Patients with Multiple Myeloma (IMS 2026) - "Nurses and pharmacists consistently expressed a preference for the preparation and administration of SC OBI vs SC manual injection. Preference was driven by the OBI’s potential for improved efficiency, time savings, a simpler preparation process, flexibility in the preparation location and a reduced risk of needlestick injuries. Limitations of this review include the differences in participant experience with the OBI across studies."

Clinical • Review • Hematological Malignancies • Multiple Myeloma

Utility of Local Cytogenetic Testing for Risk-Stratified Therapy in Newly Diagnosed Multiple Myeloma: UKMRA RADAR Experience (IMS 2026) - "Patients received induction with VRDc (bortezomib, lenalidomide, dexamethasone and cyclophosphamide), followed by ASCT. Post-ASCT, HR patients were randomised to receive isatuximab or not, alongside VRD/R consolidation/maintenance whilst standard risk (SR) patients receive MRD-guided regimens... RADAR demonstrates that risk-stratified treatment using local laboratories is feasible and quick. The majority of patients were successfully allocated to a risk-adapted treatment pathway following a first CGN test and over 90% in total with a second test. This model is applicable internationally and supports the infrastructure for accessible genetic risk-stratification for all newly diagnosed MM patients."

Hematological Malignancies • Multiple Myeloma • SDC1 • TP53

Trial in Progress: Isatuximab and Iberdomide as Immunotherapy for High-Risk Smouldering Myeloma - the UK Myeloma Research Alliance MODIFY Clinical Trial (IMS 2026) - "Patients receive isatuximab (1400 mg subcutaneous), iberdomide (Cereblon E3 ligase modulator, 1.0 mg) and dexamethasone (20 mg) for a fixed duration of 2 years (26 cycles). n/a"

Clinical • Hematological Malignancies • Multiple Myeloma • Targeted Protein Degradation • CRBN

Safety and Reliability of Isatuximab Subcutaneous On-Body Injector: Results Across the Phase 3 IRAKLIA, Phase 2 IZALCO, and Phase 1B TCD15484 Trials (IMS 2026) - " Pts with RRMM in IRAKLIA (N=263) and the Phase 1b expansion cohort (N=22) received 1400 mg Isa SC OBI plus pomalidomide and dexamethasone (d). In IZALCO, RRMM pts (N=64) received 1400 mg Isa SC OBI + carfilzomib (K)-d...Preinfusion medications included montelukast (C1), steroids, acetaminophen, and H1 antihistamines... These findings support overall low rates of IRRs and ISRs across trials, with >6000 (99.9%) Isa SC OBI injections successfully delivered. Isa SC OBI shows reproducible safety and reliability in IRAKLIA, IZALCO and Phase 1b trials, supporting it as a novel administration option for pts with MM and its potential for future exploration in at-home administration."

Clinical • P1 data • P2 data • P3 data • Hematological Malignancies • Multiple Myeloma

Real-World Treatment Patterns and Survival Outcomes in Relapsed/Refractory Multiple Myeloma (RRMM) in a Majestec-3 Study-Like Population from the US Optum Claims Database (IMS 2026) - "Novel BCMA-targeted therapies, including the teclistamab-daratumumab (Tec-Dara) combination recently approved based on results of the MajesTEC-3 study, may help improve outcomes in earlier lines. As most pts receive frontline proteasome inhibitors (PIs) and lenalidomide (Len) and/or anti-CD38 therapy, we characterized real-world treatment patterns and outcomes in an RRMM population similar to that of MajesTEC-3 to aid in contextualizing findings from this study...Most pts (84.7%) were aged >65 years; 51.1% were female; 12.9% received prior Dara; 0.6% received prior isatuximab; 80.7% and 83.5% were refractory to PIs and Len, respectively...The most common triplet regimen was Dara/pomalidomide/dexamethasone (14.1% ), a comparator in the MajesTEC-3 study... In this real-world analysis, poorer outcomes were associated with refractoriness to Len and increasing prior LOTs. These findings highlight the importance of earlier use of highly effective treatment options, such as..."

Claims database • Clinical • HEOR • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma

Real-World Outcomes of Anti-Cd38-Based Quadruplet Induction Regimens in Newly Diagnosed Multiple Myeloma: A Multinational Latin American Experience. (IMS 2026) - "Frontline regimens included Daratumumab combined with bortezomib, lenalidomide and dexamethasone (D-VRd) in 59%; Daratumumab, bortezomib, thalidomide, dexamethasone (D-VTd) in 36% and Isatuximab CUADS in 5%...However, 1% of collections failed despite plerixafor use in 55% of patients... In this large real-word Latin America experience, anti-CD38-quadruplet induction demonstrated high response depth, frequent MRD negativity, successful stem cell mobilization, and favorable survival outcomes with manageable toxicity. These findings support the feasibility and effectiveness of quadruplet-based strategies for transplant-eligible NDMM patients in Latin America."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Renal Disease • CD34

Premedication Use and Infusion-Related Reactions in Patients Treated with Subcutaneous Isatuximab: A Pooled Post Hoc Safety Analysis (IMS 2026) - " Pts with RRMM in IRAKLIA (Isa SC: n=263; Isa IV: n=264) and the Phase 1b TCD15484 trial (Isa SC dose-expansion cohort: n=22; Isa IV: n=12) received 1400 mg Isa SC OBI or 10 mg/kg Isa IV plus pomalidomide and dexamethasone (d). In IZALCO, pts with RRMM (n=74) received 1400 mg Isa SC OBI or manual injection plus carfilzomib (K)-d...Premedications included montelukast (C1 only per protocol), steroids (excluding dexamethasone), acetaminophen, H1 antihistamines, and others...In C2, most pts received 2 unique premedications, acetaminophen (Isa SC: 99.0%; Isa IV: 97.5%) and diphenhydramine (or equivalent) (Isa SC: 91.9%; Isa IV: 93.3%); some pts continued montelukast beyond C1, with use declining each cycle... Isa SC injections without premedication were more frequent than Isa IV injections without premedication, and no IRRs occurred with Isa SC injections delivered without premedications. The results support Isa SC as a safe delivery option with low incidence of IRRs."

Clinical • Retrospective data • Hematological Malignancies • Multiple Myeloma

Patient Experience, Satisfaction and Preference with Isatuximab Subcutaneous On-Body Injector from the Phase 3 IRAKLIA and Phase 2 IZALCO Clinical Trials (IMS 2026) - P2, P3 | "Two key studies evaluated Isa SC OBI in patients with relapsed/refractory multiple myeloma (RRMM): the Phase 3 IRAKLIA trial (NCT05405166) compared Isa SC OBI with Isa intravenous (IV) plus pomalidomide (P) and dexamethasone (d), and the Phase 2 IZALCO trial (NCT05704049) compared Isa SC OBI with SC manual injection plus carfilzomib (K)-d. In IRAKLIA and IZALCO, Isa SC OBI recipients reported less injection discomfort and pain and greater satisfaction vs IV or SC manual injection recipients. The results support positive patient experience with Isa SC OBI in RRMM patients."

Clinical • P2 data • P3 data • Hematological Malignancies • Multiple Myeloma

Outcomes of Patients Treated with Isatuximab Based Regimens for Relapsed Refractory Multiple Myeloma from British Columbia (IMS 2026) - "Funded combinations include those with carfilzomib and dexamethasone (Isa-Kd) and pomalidomide and dexamethasone (Isa-Pd). In this real-world cohort of predominantly len-exposed and refractory patients, both regimens demonstrated high response rates and clinically meaningful disease control. No significant PFS or OS differences were observed. Overall, these findings support the use of both regimens in relapse and particularly in 2 nd line lenalidomide exposed patients"

Clinical • Hematological Malignancies • Multiple Myeloma

MY.13: A Canadian-Led Non-Inferiority Phase III Trial in Progress Integrating Equity Principles in Transplant-Ineligible (TIE) Newly-Diagnosed (ND) Multiple Myeloma (MM) (IMS 2026) - P3 | "After 18-20 cycles of standard of care triplet or quadruplet frontline therapy including lenalidomide, CD38mAbs (daratumumab or isatuximab) and steroids, patients are randomly assigned 1:1 to discontinue their CD38mAb therapy, or to continue all standard of care therapy. This pragmatic phase III trial in progress evaluates fixed duration compared with continuous CD38mABs in older adults with TIE ND MM. The study is designed to maximize patient accessibility and generalizability of results. Incorporation of patient reported outcomes, health economics, and laboratory correlative studies, highlight the strategic opportunity taken to answer questions that matter to patients, clinicians and health care systems."

Head-to-Head • P3 data • Geriatric Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Multiple Myeloma • Renal Disease • Transplantation

Marrow Immune Features Are Most Informative of Sustained MRD Negative Response in Newly Diagnosed Standard Risk TE Patients: Findings from the UK MRA RADAR Study (IMS 2026) - "SR patients received 4 cycles of bortezomib, lenalidomide, cyclophosphamide and dexamethasone (VRDc) followed by ASCT and MRD test (flow, 10 -5 ) at D100 and 15m post ASCT. MRD-neg patients at D100 receive isatuximab alone, while MRD-pos receive multi-drug consolidation and maintenance... At baseline and pre-treatment, variables indicative of the state of the patient’s own immune system are the most informative of sustained MRD-neg response in SR patients receiving induction and ASCT."

Clinical • IO biomarker • Minimal residual disease • B2M • B3GAT1 • CCR7 • CD27 • CD8 • GZMB • KLRG1 • SDC1