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

NCI-2023-09969: Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=3 | Active, not recruiting | Sponsor: Elvira Umyarova | Recruiting ➔ Active, not recruiting | N=30 ➔ 3 | Trial completion date: Aug 2025 ➔ Jan 2026 | Trial primary completion date: Aug 2025 ➔ Jan 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Real-world survey of triplet versus quadruplet regimen preferences in transplant-ineligible (TIE) or deferred patients with newly diagnosed (ND) multiple myeloma (MM) (ASH 2025) - P3 | "Recently, data pertaining to anti-CD38 mAb-containing quadruplet regimens have been published (IMROZ: isatuximab ± bortezomib, lenalidomide, and dexamethasone [Isa-VRd]; NCT03319667 and CEPHEUS: daratumumab ± bortezomib, lenalidomide, and dexamethasone [Dara-VRd]; NCT03652064). The real-world data shows that Dara-VRd has emerged as the preferred regimen for non-frail, TIE/deferred patients with ND MM and that DRd is the preferred regimen for frail, TIE patients with ND MM. While interest for Isa-VRd saw a drastic increase for frail TIE patients with ND MM following review of the data, Dara-VRd was still the preferred anti-CD38 regimen if quadruplet regimens were considered. Despite the lack of a subgroup analysis of frail versus non-frail patients from CEPHEUS, Dara-VRd remains the preferred quadruplet therapy over Isa-VRd for TIE/deferred ND MM."

Clinical • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Transplantation

The development of FT839: An off-the-shelf CD19xCD38 dual-CAR T cell for the treatment of multiple myeloma (ASH 2025) - "In vitro cytotoxicity assays against MM cell lines RPMI-8226, OPM2, MM1.s and H929 demonstrated durable and potent cell cytotoxicity at low effector:target ratios, as a monotherapy with further deepening of response when combined with mAbs such as daratumumab or sarclisa, or T cell engagers such as teclistamab or talquetamab (exceeding 90% cytotoxicity in each case). Collectively, FT839 is engineered to eliminate cancer cells with broad and heterogenous antigen expression by a unique dual-CAR system and in combination with standard of care therapeutics, including mAbs and TCEs via hnCD16 and CD3-CFR transgenes, to overcome multiple challenges that have limited autologous CAR T-cell therapies in treating MM. Moreover, as an off-the-shelf CAR T-cell therapy, FT839 is intended for broad and on-demand access without the need for complicated and variable manufacturing processes or intense conditioning chemotherapy."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma

Real-world treatment landscape after anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma: An international Study (ASH 2025) - "Novel BCMA-targeted therapies, such as CAR T-cells (cilta-cel from 2nd line, ide-cel from 3rd line) and bispecific T-cell engagers (e.g., teclistamab, elranatamab from 4th line), have become new standards of care...Abbreviations: K=carfilzomib; E=elotuzumab; Pom=pomalidomide; d=dexamethasone; Isa=isatuximab; F=panobinostat; R=lenalidomide; Tec=teclistamab; X=selinexor; Elra=elranatamab; Belamaf=belantamab mafodotin; Ixa=ixazomib... This real-world study of 100 MM patients relapsing after anti-BCMA CAR T-cell treatment shows that 91% were in their 4th or 5th line of therapy. A large majority were triple-class exposed, and 52% were lenalidomide-refractory. In the absence of a clear standard of care, common treatments were identified: elotuzumab- and isatuximab-based regimens in the 3rd line; teclistamab and elotuzumab-based options in the 4th line; and teclistamab, elranatamab, and belantamab mafodotin in the 5th line."

CAR T-Cell Therapy • Clinical • HEOR • Real-world • Real-world evidence • Cardiovascular • Diabetes • Dyslipidemia • Hematological Malignancies • Hypertension • Metabolic Disorders • Multiple Myeloma • Renal Disease

Impact of addition of anti-CD38 monoclonal antibody to first line therapy in newly diagnosed multiple myeloma with high risk cytogenetics: A systematic review and meta-analysis of randomized trials (ASH 2025) - "Daratumumab (DARA) and Isatuximab (ISA) are two FDA approved anti-CD38 mABs currently in use. Our study shows that addition of an anti-CD38 mAb significantly improves PFS in patients with NDMM with HRCA. This benefit seems to be primarily driven by studies utilizing DARA. No statistically significant benefit was observed for response end points such as MRD negativity in this subgroup highlighting the need for research to develop more effective regimens."

Retrospective data • Review • Hematological Malignancies • Multiple Myeloma

Isa-PACE in the treatment of functionally high-risk multiple myeloma: Intermediate results. (ASH 2025) - "In the absence of chimeric antigen receptor T-cell (CAR-T) therapy in Russia, the Isa-PACE (isatuximab + cisplatin, doxorubicin, cyclophosphamide, and etoposide) combination is considered a potential bridge therapy to auto-HSCT...All patients continue to receive maintenance therapy with isatuximab and lenalidomide, while maintaining MRD-negative status...Intermediate assessment of PET/CT imaging effectively reflected the response to treatment and identified the need for treatment intensification. Expanding the sample size will help to clarify the prognostic significance of this approach and aid in stratifying patients with NDMM."

Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Human Papillomavirus Infection • Infectious Disease • Multiple Myeloma • Neutropenia • Plasmacytoma • Thrombocytopenia

Indirect treatment comparison of belantamab mafodotin + pomalidomide + dexamethasone versus comparator regimens in lenalidomide-exposed relapsed/refractory multiple myeloma: A network meta-analysis (ASH 2025) - P3 | " In the len-exposed population, the PFS network comprised 8 RCTs (including DREAMM-8) with comparator regimens: carfilzomib + dexamethasone (Kd), Kd + daratumumab (DKd), isatuximab + carfilzomib + dexamethasone (IsaKd), bortezomib + dexamethasone (Vd), DVd, PVd, and selinexor + Vd (SVd). In the absence of head-to-head randomized controlled trials, these ITC data suggested a high probability that PFS consistently favored BPd vs comparator regimens of interest in len-exposed patients with RRMM, with consistent findings in the IPTW analysis reducing uncertainty in the base-case NMA findings."

Retrospective data • Hematological Malignancies • Multiple Myeloma

A comparison between subcutaneous isa-vrd from the isasocut study and intravenous isa-vrd from the imroz study in patients with transplant- ineligible newly diagnosed multiple myeloma (ASH 2025) - P=N/A, P3 | "Introduction: Isatuximab (Isa) given intravenously (IV) with bortezomib, lenalidomide, and dexamethasone (VRd) is associated with a significant progression-free survival benefit in patients with newly diagnosed multiple myeloma (NDMM) ineligible for transplant (IMROZ study, NCT03319667). The analysis of Isa OBI-VRd from the ISASOCUT study and Isa IV-VRd from the IMROZ study showed a lower incidence of PN with Isa OBI-VRd, regardless of age subgroup. This suggests that weekly bortezomib as administered in ISASOCUT may be more tolerable for patients than the twice weekly schedule given in IMROZ with regard to PN, while maintaining efficacy in those <75 years and ≥75 years old. In addition, this analysis further supports the efficacy and safety of the OBI delivery method."

Clinical • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Respiratory Diseases • Transplantation

Anti-CD38-based quadruplet versus triplet induction regimens in transplant-ineligible newly diagnosed multiple myeloma: A systematic review and meta-analysis (ASH 2025) - "Introduction Triplet induction therapy with either daratumumab, lenalidomide, and dexamethasone (D-Rd) or bortezomib, lenalidomide, and dexamethasone (VRd) has long been the standard of care for transplant-ineligible patients with newly diagnosed multiple myeloma (TIE-NDMM)...The quadruplet regimens comprised an anti-CD38 monoclonal antibody (daratumumab or isatuximab), a proteasome inhibitor (bortezomib or carfilzomib), an immunomodulatory drug (lenalidomide) or alkylator (melphalan or cyclophosphamide), and a corticosteroid...While quadruplet regimens were associated with higher rates of SAEs and grade 3-4 infections, no significant differences were observed in the rates of grade 3-4 neutropenia or thrombocytopenia. Careful patient selection is essential to optimize outcomes and mitigate treatment-related toxicity."

Retrospective data • Review • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Thrombocytopenia • Transplantation

Safety and efficacy of carfilzomib-based combinations in relapsed/refractory multiple myeloma patients in a real-world Setting : Results of a french single academic center retrospective study. (ASH 2025) - "All patients had been exposed to IMiDs (lenalidomide, pomalidomide, thalidomide), 89% to proteasome inhibitors (bortezomib, carfilzomib, ixazomib), and 64% to anti-CD38 monoclonal antibodies (daratumumab, isatuximab). Initial weekly dosing of K followed by spacing out infusions in responding patients led to better tolerance. Currently, K-based combinations also represent interesting options as bridging therapy to CAR T-cells therapies."

Real-world • Real-world evidence • Retrospective data • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Gastrointestinal Disorder • Heart Failure • Hematological Malignancies • Hypertension • Multiple Myeloma

Ktx-1001, a potent, selective MMSET/NSD2 inhibitor, enhances immunomodulatory and immune-directed therapies in preclinical models of multiple myeloma (ASH 2025) - P1 | " MM cell lines harboring t(4; 14) translocation and resistant to standard therapies were treated with escalating concentrations of KTX-1001 in combination with pomalidomide (POM), mezigdomide (MEZI), anti-CD38 monoclonal antibodies (daratumumab, [DARA], isatuximab, [ISA]), and T-cell engagers (teclistamab (TEC, anti-BCMA) and talquetamab (TALQ, anti-GPRC5D). These preclinicalfindings supportthe therapeutic potential of combining KTX-1001 with immunomodulatory and immune-directed therapies in MM. KTX-1001 demonstrated synergistic reductions in cell viability in IMiD-resistant t(4; 14) cell lines when combined with POM or MEZI. In immune-based co-culture assays, pre-treatment with KTX-1001 enhanced cytotoxicity induced by T-cell engagers, TEC and TALQ in t(4; 14) MM cell lines."

Immunomodulating • IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • CD4 • CD69 • CD8 • NSD2

High-dimensional profiling reveals predominant depletion of NK cell effector phenotypes in relapsed/refractory multiple myeloma patients treated with anti-CD38 therapy (ASH 2025) - "Subset proportions were expressed as percentage of lymphocytes, unlessstated otherwise. Patients were treated predominantly with daratumumab over isatuximab (92%, 82%, and 100%of CD38‑IMID, CD38-PI, and CD38-mono regimens). This study provides in-depth analysis of immune cells in anti-CD38 mAb-treated patientsusing conventional and spectral cytometry. Higher BASE proportion of CD38+ NK cells was associatedwith worse PFS, while higher levels of mature B cells predicted better outcomes. Post-therapy, CD38+ NKand CD38+ T cells, total NK cells, and total B cells decreased, while total T cells increased."

Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • B3GAT1 • KLRB1 • NCAM1

Novel indirubin-3-monoxime derivative I3MV-8b enhances anti-CD38 monoclonal antibody efficacy in multiple myeloma through dual proteasome and HDAC6 inhibition (ASH 2025) - "Clinically approved anti-CD38 mAbs, daratumumab andisatuximab, have become the foundation of therapy for MM. Our findings suggest that compound 8b enhances CD38 expression and modulates immune cell function,offering a promising strategy to potentiate anti-CD38 mAbs against MM."

Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • IFNG • SDC1 • TIGIT • USP7

Novel insights in therapeutic antibody therapies using advanced microscopy techniques (ASH 2025) - "Leveraging these tools, we aim to decode the spatial organization and functionaldynamics of immunoreceptors in MM, using CD38 as a model receptor.MethodsWe applied dSTORM to map CD38 expression in Daratumumab (Dara) resistant (n=22) and Dara naïve(n=30) MM patients, detecting residual CD38 in CD38 negative patients (n=3) using the multi-epitope (ME)antibody CD38ME. As two-color dSTORM imaging and subsequent colocalization analysis revealedevidence of epitope shielding by therapeutic Dara, we tested whether Isatuximab (Isa) can overcome thiseffect...However, Isa inducesslower but more sustained CD38 polarization compared to Dara, highlighting potential differences in theirmechanisms of action. These two imaging approaches combined can provide critical insights into themechanisms of immune cell-mediated killing as well as mechanisms underlying therapeutic responseand resistance, thereby improving diagnostics and enabling personalized treatment strategies for MMpatients."

IO biomarker • Metastases • Hematological Malignancies • Multiple Myeloma

An immune-therapeutic salvage strategy for 'functional' high-risk (FHR) multiple myeloma (MM) incorporating iberdomide, isatuximab, and dexamethasone – the IBIS study amarc 20-01. (ASH 2025) - P2 | "Of 50 pts: 28%, 32%, 16%, 12% with 0, 1, 2 or 3 high-risk chromosomal abnormalitiesrespectively; 34% fulfilling IMS2025 high-risk criteria, 54% standard-risk and 12% in whom diagnosticCG/FISH were omitted, 83% received PI-IMID 1L (76% VRd, 3% VRd+chemotherapy, 7% VRd+Selinexor),10% bortezomib-cyclophosphamide-dexamethasone (VCD), 7% lenalidomide-dexamethasone (Rd), 24%ASCT; 10% 1REF to 1L and 90% relapsed after initial response to 1L, of these 72% had ³PR to 1L. In this second planned interim analysis, IB-IS-DEX was well-tolerated, achieved early diseasecontrol and demonstrated promising efficacy in FHR MM. Preliminary ctDNA genomic analyses highlight asubstantial burden of adverse biology, with frequent del(17p), MYC copy number gains, and high cTFamong pts with PD. Updates on survival will be presented at the conference."

CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Insomnia • Multiple Myeloma • Neutropenia • Respiratory Diseases • Septic Shock • Sleep Disorder • Squamous Cell Carcinoma

Final results of a multi-center phase 2 trial of isatuximab-lenalidomide in patients with high risk smoldering multiple myeloma (HRSMM) (ASH 2025) - P3 | "Randomized trials of lenalidomide (LEN) +/- dexamethasone vs. observation (E3A06,QuiReDex), carfilzomib-lenalidomide-dexamethasone (KRd) with transplant, consolidation, andmaintenance (GEM-CESAR), and anti-CD38 monoclonal antibodies alone (CENTAURUS) or with KRd(ASCENT), have all shown efficacy in terms of response and progression free survival (PFS) in suchpatients; some have also reported improved overall survival (OS)... Patients were treated on 28-day cycles with ISA 20 mg/kg IV on days 1, 8, 15, and 22 of cycle (C)1, days 1 and 15 of C2-6, and day 1 of C7-30, together with LEN 25 mg PO on days 1-21 of cycles 1-6; methylprednisolone 100mg iv was given prior to each ISA infusion... ISA-LEN is a well-tolerated therapy for high risk smoldering multiple myeloma, with a 4-yearPFS of 94.3%. The final results of this phase 2 trial compare favorably with the natural history of PETHEMAHRSMM patients (Perez-Persona et al. Blood 2007), while limiting both steroid and LEN use."

Clinical • P2 data • Constipation • Gastroenterology • Gastrointestinal Disorder • Leukopenia • Multiple Myeloma • Neutropenia • Pancreatic Adenocarcinoma • Pancreatic Cancer • Smoldering Multiple Myeloma • Thrombocytopenia

Isatuximab (Isa) subcutaneous (SC) via an on-body injector (OBI) vs isa intravenous (IV), plus pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma (RRMM): East asia subgroup results from the randomized, non-inferiority, phase 3 iraklia study (ASH 2025) - P3 | "Baseline characteristics of the East Asian subgroup were generallybalanced between the two arms and generally comparable to the overall global population (median age62 years; median 2 prior LOT; 29.5% high-risk cytogenetics; 82.9% refractory to lenalidomide; 7.6% priorexposure to daratumumab). The efficacy, safety and pharmacokinetic results between Isa SC vs IV + Pd in the East Asianpopulation from the IRAKLIA study were consistent with the results of the overall global population, inwhich non-inferiority of ORR, Ctrough at C6D1, ≥VGPR and Ctrough at C2D1 was demonstrated andstatistically significantly fewer infusion reactions and higher patient satisfaction were also noted for SC vsIV. These results support the potential use of Isa SC delivered via OBI in East Asian patients anddemonstrate the potential of this delivery method to improve patient experience and practice efficiency."

Clinical • Head-to-Head • P3 data • Hematological Malignancies • Multiple Myeloma

Safety and efficacy of triple vs quadruple therapy in transplant ineligible multiplemyeloma patients – a meta-analysis of randomized controlled trials (ASH 2025) - "The OCTANS and ALCYONE trials assessed the addition ofdaratumumab to bortezomib, melphalan, and prednisone (D-VMP against VMP), and the BENEFIT trialcompared the addition of Bortezomib to Isatuximab, lenalidomide, and dexamethasone (Isa-VRd vs Isa-Rd). Conclusion This meta-analysis demonstrates that quadruplet therapy significantly improves progression-freesurvival, overall survival, response depth, and MRD negativity compared to triple therapy in TIE NDMM.Although grade 3-4 TEAE appeared to increase, this difference was not statistically significant. Thesefindings support the consideration of quadruplet regimens as a more effective upfront strategy in TIENDMM patients, with attention to patient-specific tolerability and individualized risk–benefit profiles."

Retrospective data • Hematological Malignancies • Multiple Myeloma • Transplantation

The evolution to hepta-refractory myeloma involves sequential loss of CD38, BCMA and GPRC5D (ASH 2025) - "CD38, the target of daratumumab or isatuximab, was affected by4p deletions in 5/17 (29%) patients, including 2 patients with focal biallelic loss.The BCMA-encoding gene TNFRSF17 was altered in 9/17 (53%) patients: monoallelic loss in 2, and biallelicevents in 7 patients...Of two patients treated with talquetamab, one acquired biallelicGPRC5D events at relapse, having already harbored a TNFRSF17 biallelic event after BCMA-directedtherapies...The third patient, treated sequentially withtalquetamab, teclistamab and CAR-T, exhibited pronounced parallel evolution with the emergence offour distinct biallelic GPRC5D events and two independent TNFRSF17 deletions, underscoring theadaptive capacity of late-stage MM.We also explored the utility of WGS in guiding clinical decisions... Hepta-refractory MM is marked by extensive genetic alterations associated with high-riskdisease and multidrug resistance. WGS proved helpful in selecting further therapies for this ultra-refractory..."

IO biomarker • Hematological Malignancies • Multiple Myeloma • CDKN2C • CRBN • CUL4A • DDB1 • IKZF1 • SDC1 • TNFRSF17 • TP53

Low conversion rates to minimal residual disease (MRD) negativity despite improved IMWG responses with lenalidomide-isatuximab maintenance after autologous stem cell transplant (ASCT) in multiple myeloma. (ASH 2025) - P2 | "More than half of the patients showed an improvement in IMWG response, with doubletmaintenance of lenalidomide and CD38 MoAb in patients with persistent MRD following ASCT in thispatient population, which was enriched for high-risk disease and predominantly received a quadrupletCD38 MoAb-based induction regimen. There is thus significant potential for continued exploration ofnovel approaches, including CAR T-cell therapy and bispecific antibodies, to further enhance responses inpatients with persistent MRD."

Clinical • IO biomarker • Minimal residual disease • Residual disease • Back Pain • Constipation • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Malignancies • Hypertension • Infectious Disease • Multiple Myeloma • Musculoskeletal Pain • Neutropenia • Prostate Cancer • Respiratory Diseases • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma • Transplantation • CD4 • PD-L1

Apixaban pharmacokinetics in newly diagnosed multiple myeloma patients treated in the benefit and isasocut clinical trials: The apixabor/mibapix study (ASH 2025) - "Bortezomib (V) is classified as aCYP3A4 inhibitor, while dexamethasone (DXM) is classified as P-gp and CYP3A4 inducers (Sorigue 2020).So, we sought to study the DDI interaction between apixaban and the NDMM SOC regimens.We present a study assessing (1) the apixaban concentration-time profile in NDMM receiving low dose d-containing regimens, (2) whether the addition of bortezomib increases apixaban concentration, (3) thethrombosis and bleeding rates within 6 months after the start of treatment.MethodsThis study was ancillary to the phase 3 randomized 2 arms BENEFIT (Isatuximab +VRd and IsaRd) andphase 2 single arm ISASOCUT (Isa 1400mg SC OBI +VRd) studies for transplant ineligible (TI) NDMMpatients and was offered to patients receiving apixaban for thromboprophylaxis per protocol twice daily.V was administered weekly (1.3 mg/m² SC) for the first 12 months, then days 1 and 15 up to month 18 inBENEFIT, while V was administered biweekly in cycle 1, and weekly thereafter..."

Clinical • PK/PD data • Cardiovascular • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Thrombosis

The allogeneic fully human anti-CD38-CAR-γδ T cells enable off-the-shelf CAR-T cell therapy for myeloma (ASH 2025) - "Introduction The prognosis for myeloma patients has been improved by proteasome inhibitors (PIs),immunomodulatory drugs (IMiDs), and antibodies, particularly anti-CD38 antibodies such asdaratumumab and isatuximab...Thus, weattempted to develop fully human anti-CD38-CAR γδ T cells for repetitive off-the-shelf use in myelomapatients.Methodsγδ T cells were cultured using zoledronic acid and IL-2 and expanded from PBMCs of healthy donors...TheseCAR-γδT cells have fully human scFv and MHC-unrestricted cytotoxicity, so they can be used multipletimes, which is economically advantageous. Allogeneic fully human anti-CD38-CAR γδ T cells may shednew light on the treatment of myeloma patients as an off-the-shelf therapeutic agent, potentially leadingto an increase in cutting-edge treatment options."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma • IL2

Effect of isatuximab use in combination with autologous stem cell transplant on mobilized stem cell product and post-transplant immune recovery - Results of a randomized prospective Phase 2 trial (ASH 2025) - P2 | "Use of Isatuximab in the pre-stem cell collection and immediate post ASCT period leads tofavorable changes in the immune repertoire of both the stem cell product and peripheral blood at short-term recovery from ASCT. Further study of this approach is warranted in patients undergoing ASCT."

Clinical • Combination therapy • IO biomarker • P2 data • Post-transplantation • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Transplantation • CD8 • ITGA6

Life-years and quality-adjusted life-years with belantamab mafodotin, bortezomib, and dexamethasone vs alternative regimens in patients with Relapsed/Refractory multiple myeloma who received ≥1 prior line of therapy (ASH 2025) - P3 | "To estimate QALYs for each treatment, health state utilities were informed by DREAMM-7 EQ-5D-3L data and adjusted for adverse event (AE) disutilities; the proportion of patients with grade ≥3 AEsbased on trial data was used to calculate the disutilities for each alternative therapy. BVd led to more LYs (12.0) and QALYs (9.8) compared with all alternative therapies (carfilzomiband dexamethasone [Kd], 8.1 and 6.6, respectively; daratumumab and Kd [DKd], 10.1 and 8.2; isatuximaband Kd [IsaKd], 10.1 and 8.2; bortezomib and dexamethasone [Vd], 6.0 and 4.9; pomalidomide and Vd,8.1 and 6.6; selinexor and Vd, 7.3 and 5.9; DVd, 8.8 and 7.2). BVd led to substantially more LYs and QALYs compared with alternative treatment regimensfor RRMM, highlighting the potential of BVd to extend survival and enhance clinical and quality-of-lifebenefits for these patients. These insights are critical to support clinical and health policy decision-makingin MM at first relapse, supporting..."

Clinical • HEOR • Hematological Malignancies • Multiple Myeloma

Response-adapted randomization to Q2W vs Q4W isatuximab beyond cycle 6 in relapsed multiple myeloma: Results from a phase 2 Study of isa-pd in lenalidomide- and PI-exposed patients (ASH 2025) - P2 | "Introduction: Isatuximab (Isa), an anti-CD38 mAb, is approved with pomalidomide and low-dosedexamethasone (Isa-Pd) for RRMM after ≥2 prior therapies. Isa-Pd showed robust efficacy with manageable safety and rapid responses in first-relapseRRMM pts after a Len+PI-based regimen. In pts with ≥VGPR, Isa Q4W provided comparable efficacy withimproved safety and compliance versus Q2W, suggesting greater convenience without compromisingefficacy. Pts with <VGPR benefited from continued Q2W dosing, with evidence of ongoing responseimprovement."

Clinical • P2 data • Hematological Malignancies • Multiple Myeloma