Blenrep (belantamab mafodotin-blmf) / GSK, Pfizer - LARVOL DELTA

Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=88 | Recruiting | Sponsor: Alliance for Clinical Trials in Oncology | Suspended ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Health-related quality of life with belantamab mafodotin in patients with relapsed or refractory multiple myeloma (RRMM): An exploratory analysis of overall quality of life in dreamm-7 (ASH 2025) - P3 | "In DREAMM-7 (NCT04246047), belamaf with bortezomib and dexamethasone (BVd) significantlyprolonged progression-free survival and overall survival vs daratumumab, bortezomib, anddexamethasone (DVd) in patients with RRMM who received ≥1 prior line of therapy. Despite being common with belamaf, ocular events did not have a meaningful impact onHRQOL. Notably, in patients with bilateral worsening of BCVA to 20/50 or worse, HRQOL was maintained,likely due to the transient nature of ocular events and their management with dose reductions anddelays, which have been shown to improve tolerability while maintaining efficacy. The significant efficacybenefits of belamaf prolonged time to deterioration in disease-specific symptoms and physicalfunctioning, including self-care and walking."

Clinical • HEOR • Hematological Malignancies • Multiple Myeloma

Phase II trial of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone in multiple myeloma following BCMA CAR T-cell therapy (ASH 2025) - "Four patients received cilta-cel, five patients receivedinvestigational BCMA CAR T-cell therapies, and two patients received both; all patients responded to eachCAR T administered.The ORR was 9/11 (82%) meeting the statistical threshold for efficacy. Bela-KPd utilizing less frequent dosing of Bela led to a favorable efficacy and safety profile,even among patients with prior BCMA CAR T-cell therapy and carfilzomib and pomalidomiderefractoriness. Bela-KPd is a promising regimen for patients following relapse after BCMA CAR T-celltherapy.Partial funding and study drug were provided by GSK and Amgen (ClinicalTrials.gov identifierNCT05789303)."

CAR T-Cell Therapy • IO biomarker • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Ophthalmology • Thrombocytopenia

Belantamab mafodotin, carfilzomib, lenalidomide, and dexamethasone for relapsed or refractory multiple myeloma. (PubMed, Blood Adv) - P1/2 | "These results support the feasibility of KRd-b with extended-interval belamaf and warrant further evaluation in phase 2 trials to confirm its clinical benefit in RRMM. This trial is registered at www.clinicaltrials.gov as NCT04822337."

Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Ophthalmology

A review of the clinical efficacy of monoclonal antibody (mAb)-based therapies for relapsed/refractory multiple myeloma (RRMM). (PubMed, Expert Opin Biol Ther) - "We review mechanisms of action, efficacy, real-world effectiveness, and key aspects of the safety profiles of daratumumab, isatuximab, elotuzumab, and belantamab mafodotin in RRMM. mAb/ADC-based regimens remain key options in this setting, offering practical, effective, and tolerable approaches for real-world practice. Ongoing research will inform individualized treatment choices and rational sequencing of therapies, with a need for immune-based biomarkers and biologic profiling to enable optimal, integrated use of mAbs, ADCs, CAR T-cell therapies, and bispecific antibodies to further improve outcomes for patients with RRMM."

IO biomarker • Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Belantamab for the Treatment of Multiple Myeloma: Results from Part 1 of the First-in-Human Phase 1/2 DREAMM-20 Trial (IMS 2025) - P1 | "Introduction: Belantamab mafodotin (belamaf) is a B-cell maturation antigen (BCMA)–targeted monoclonal antibody (mAb) conjugated with a monomethyl auristatin F (MMAF) payload. Belantamab had a favorable safety profile, with no DLTs, TRAEs leading to discontinuation, or grade ≥2 corneal events associated with belantamab. Encouraging preliminary clinical activity was observed, with durable responses occurring across dose levels in this heavily pretreated, triple class−exposed population. These findings support the potential of belantamab to provide clinical activity with an acceptable safety profile."

First-in-human • P1/2 data • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Ophthalmology

Next generation ConjuAll BCMA antibody-drug conjugates (ADCs) LCB14-2524 and LCB14-2516 show increased efficacy in preclinical models of multiple myeloma (AACR 2026) - "This target has emerged as one of the most important for targeted therapies in relapsed/refractory multiple myeloma (RRMM) as demonstrated by the recent approval of the ADC belantamab mafodotin in combination with bortezomib and dexamethasone. In vivo, both LCB14-2516 (LBG-proPBD) and LCB14-2524 (LBG-MMAF) were more active than the belantamab mafodotin biosimilar across OPM2, MM.1S and NCI-H929 CDX models. Both LCB14-2516 (LBG-proPBD) and LCB14-2524 (LBG-MMAF) ADCs utilize clinically validated LCB technology with promise to increase the therapeutic index of BCMA targeted ADCs and are progressing through IND enabling studies for clinical development."

ADC • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

ALANIS: A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Feb 2032 ➔ Dec 2032 | Trial primary completion date: Aug 2027 ➔ Dec 2032

Trial completion date • Trial primary completion date • Amyloidosis

Antibody-drug conjugates for the treatment of hematologic malignancies (AACR 2026) - "Belantamab mafodotin is composed of a monoclonal antibody targeting BCMA and is conjugated to the cytotoxic payload monomethyl auristatin F (MMAF), a microtubule disrupting agent, and is approved for multiple myeloma...Gemtuzumab oxogamicin targets the CD33 receptor on myeloid cells and is approved for AML...Inotuzumab ozogamicin targets the CD22 receptor on B-cell precursor leukemic cells and is approved for ALL in pediatric patients with R/R CD22-positive B-cell precursor ALL...Brentuximab vedotin is composed of a monoclonal antibody targeting the CD20 antigen and conjugated to microtubule disrupting agent monomethyl auristatin, which serves as the payload, for chronic Hodgkin's lymphoma...mPFS was 4.2 months (95% CI: 2.9, 7.1) with BV+R2 and 2.6 months (95% CI: 1.4, 3.1) with Pbo+R2 (HR 0.53, 95% CI: 0.38, 0.73). The ORR was 64.3% (95% CI: 54.7, 73.1) and 41.5% (95% CI: 32.5, 51.0), respectively."

ADC • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Oncology • CD22 • CD33

Overcoming acquired and intrinsic resistance with an integrated ADC platform (AACR 2026) - "An Her2- and Trop2-positive gastric PDX shown clear resistance (TGI < 10%) to trastuzumab deruxtecan and sacituzumab govitecan, two clinically used Her2 and Trop2 ADCs respectively, limited response (TGI 10-30%) to Herceptin and no response to Dxd treatment. In addition, the well-known ocular toxicity associated with multiple clinically used ADCs can be recapitulated by a cell-based assay using human corneal epithelial cells. On this platform, belantamab mafodotin, trodelvy and T-DM1 demonstrated consistent high, medium and low cytotoxicity respectively.The integration of above-mentioned platforms facilitates a deep understanding of resistance mechanisms and promotes the development of ADCs that are better aligned with clinical needs, with the ultimate goal of overcoming resistance."

ADC • IO biomarker • Oncology • HER-2

Bone marrow from acute myeloid leukemia (AML) and multiple myeloma (MM) patients can be used to evaluate target expression and on-target efficacy for novel antibody drug conjugates (ADCs) (AACR 2026) - "Gemtuzumab ozogamicin (Mylotarg), Belantamab Mofodotin (Blenrep) and Trastuzumab vedotin were evaluated for toxicity to hematopoietic progenitor cells using the colony forming cell assay (CFC) in diseased (on-target efficacy) and normal bone marrow (NBM) (off-target toxicity). Blenrap in MM patient bone marrow had IC50 values which ranged from 4.4 to 46 µg/mL with an average IC50 value of 21 µg/mL, compared to evaluation in NBM which resulted in IC50 values > 30 µg/mL (highest tested concentration) and rarely had any impact on colony growth. These data suggest that the CFC assays with primary normal and diseased bone marrow cells may provide insight as to relative potency of an ADC on a disease-specific target as well as potential off-target toxicity to normal hematopoietic progenitors."

ADC • Clinical • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • CD33 • HER-2

Synthbody™- A novel multivalent multispecific antibody drug conjugate platform demonstrates combinatorial logic-gated "synthetic" targeting of cancer antigens with log order enhanced internalization and potency (AACR 2026) - "Antibody Drug Conjugates (ADCs), such as trastuzumab deruxtecan, achieve complete responses >20% and duration of response >30 months in patients with metastatic Her2+ breast cancer1...SDF-061390E (and SDF-061390E-MMAF) demonstrates >30x greater internalization and >80x greater potency when compared, respectively, with the BCMA-targeting antibody Belantamab and Belantamab mafodotin in human myeloma cells...Optimized Synthbody™ constructs show excellent production in CHO cells, developability and IgG-like PK in vivo.The novel Synthbody™ platform demonstrates broad utility as ADC and biologic therapeutics, with capabilities for coordinated targeting, advanced logic-gated control and multifunctional action that may complement or ultimately replace current IgG-based biologics.1 Cortes et al. Nat Med 2024"

ADC • IO biomarker • Breast Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Multiple Myeloma • Oncology • Solid Tumor • HER-2

Belantamab mafodotin, lenalidomide and dexamethasone (BelaRd) in newly diagnosed intermediate-fit and frail myeloma. (PubMed, Blood) - P1/2 | "Overall, BelaRd is an effective regimen for transplant-ineligible NDMM patients and warrants a phase 3 study in this setting. OAEs' impact to quality of life appears limited and implementation of the hematologist-led VRA tool may eventually reduce the necessity for ophthalmologist assessments."

Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Ophthalmology • Transplantation

DREAMM 14: Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=177 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology

Efficacy and Safety of Belantamab Mafodotin with Bortezomib Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: the DREAMM-6 Arm B Trial. (PubMed, Clin Cancer Res) - P1/2 | "BVd demonstrated manageable safety and clinical activity across all dosing cohorts in heavily pretreated RRMM, supporting the 2.5 mg/kg Q3W dose."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Ophthalmology

North American Enrollment in Clinical Trials: An Emerging Issue for Regulatory Approval (HOPA 2026) - "In the Asian region, the median OS was not estimable for glofitamab plus gemcitabine and oxaliplatin versus 8.2 months in rituximab plus gemcitabine and oxaliplatin.1 In the rest of the world, the median OS was 21.2 months for glofitamab plus gemcitabine and oxaliplatin versus 27.8 months for rituximab plus gemcitabine and oxaliplatin.1 Even when excluding the OS data, which could be confounded by subsequent therapy, the pooled non-Asian patient data (ie, in United States, Europe, Australia) found glofitamab plus gemcitabine and oxaliplatin did not have significantly longer PFS than with rituximab plus gemcitabine and oxaliplatin.1 The Asian population had more lenalidomide exposure and only 2 of the 131 patients previously received CAR T therapy compared with 19 of 143 patients from the rest of the world.1 In the United States, CAR T therapy is standard of care second- or third-line therapy, whereas there is limited or no access to CAR T therapy in Asia3 Was this an..."

Clinical • Late-breaking abstract • B Cell Lymphoma • Breast Cancer • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Genito-urinary Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Leukemia • Lung Cancer • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • HER-2

NCE393WB: Advancing Myeloma Care: The Pharmacist's Role in Safe and Effective Use of Blenrep (HOPA 2026) - "Participants will gain insights into the clinical evidence for Blenrep, recommendations for managing adverse events, and guidance on incorporating REMS requirements into pharmacy systems. Speakers: Matthew Chui, PharmD, BCOP, Clinical Pharmacy Manager, University of Miami Eleni Allen, PharmD, RPh US Medical Lead, Risk Mitigation Strategy, GSK This information is scientific and non-promotional in nature, and this symposium is sponsored by GSK Medical Affairs."

Hematological Malignancies • Multiple Myeloma

Changing the Survival Landscape in RRMM with Novel ADC (ICKSH 2026) - "In the phase 3 DREAMM -7 trial, patients with RRMM after at least one prior line were randomized to belantamab mafodotin plus bortezomib and dexamethasone (BVd) versus daratumumab plus bortezomib and dexamethasone (DVd)...In the phase 3 DREAMM -8 trial, belantamab mafodotin in combination with pomalidomide and dexamethasone (BPd) likewise yielded markedly prolonged progression free survival ( PFS) and higher MRD -negative deep responses compared with the control arm (PVd) , including in clinically relevant subgroups such as patients with lenalidomide -refractory disease and those previously exposed or refractory to anti -CD38 antibodies. Belantamab mafodotin has a distinct toxicity profile, most notably ocular toxicity that is mechanistically linked to the ADC payload and occurs more frequently in belantamab -containing regimens than comparator triplets...In conclusion, the superior efficacy across OS, PFS and DOR in the DREAMM -7 and DREAMM -8 trials supports the..."

Hematological Malignancies • Multiple Myeloma • Ophthalmology

EAE127: A PHASE 1/2, DOSE AND SCHEDULE EVALUATION STUDY TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN ADMINISTERED IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE WITH OR WITHOUT DARATUMUMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA PREVIOUSLY TREATED WITH ONE TO THREE LINES OF THERAPY WHO ARE LENALIDOMIDE REFRACTORY (clinicaltrialsregister.eu) - P1/2 | N=12 | Active, not recruiting | Sponsor: Hellenic Society Of Hematology | N=60 ➔ 12

Enrollment change • Hematological Malignancies • Multiple Myeloma • Oncology

IMPACT OF USING RELATIVE DOSE INTENSITY VERSUS INDIVIDUAL PATIENT DOSING: A CASE STUDY USING BELANTAMAB MAFODOTIN DATA FROM THE DREAMM-7 STUDY IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (ISPOR 2026) - "Data from intent-to-treat population of the phase 3 DREAMM-7 trial of belamaf plus bortezomib/dexamethasone (BVd) versus daratumumab plus bortezomib/dexamethasone (DVd) in relapsed/refractory multiple myeloma were used to evaluate alternative methods for calculating lifetime drug and administration costs in a CEM when dosing intervals are expected to increase over time. United Kingdom drug acquisition and administration costs were estimated and discounted at 3.5%/year. When doses and dosing intervals vary over time, applying an overall mRDI can inaccurately estimate long-term drug and administration costs compared to IPD weekly data. Accurate methods that reflect observed dosing and treatment patterns are critical for payers and health technology assessment bodies to ensure robust cost-effectiveness evaluations.FUNDING: GSK (study 300091)."

Case study • Clinical • Hematological Malignancies • Multiple Myeloma

Addressing unmet needs in relapsed/refractory multiple myeloma: an Italian Delphi consensus on current challenges and emerging therapies. (PubMed, Front Oncol) - "The increasing use of novel agents in frontline therapy has led to a growing population refractory to key drugs such as lenalidomide and daratumumab, resulting in limited effective options in subsequent lines...Despite multiple available agents and combinations, effective treatment of all patients with relapsed/refractory multiple myeloma remains a major unmet need. Given their distinct mechanism of action, immunotherapies hold significant potential to address this gap and improve clinical outcomes."

Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

BUDGET IMPACT MODEL (BIM) OF BELANTAMAB MAFODOTIN (BELAMAF) IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE (BVD) IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) IN THE UNITED STATES (US) (ISPOR 2026) - "Median progression-free survival, median overall survival, median duration of therapy, and median time to next treatment were input from published clinical trials for each included regimen and from the DREAMM-7/DREAMM-8 trials for BVd, daratumumab+Vd, and pomalidomide+Vd. Addition of BVd to formularies for 3L+ RRMM is a manageable financial consideration for payers, with negligible budget impact PMPM and modest budget saving by Y3. FUNDING: GSK (study 221158)"

Clinical • Combination therapy • HEOR • Hematological Malignancies • Inflammation • Multiple Myeloma

GEM-BELA-VRd: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: PETHEMA Foundation | Completed ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

GEM-BELA-VRd: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: PETHEMA Foundation | Not yet recruiting ➔ Completed

Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Linvoseltamab (LINVO) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) in the LINKER-MM1 study: Longer follow-up (FU) and subgroup analyses (DKK 2026) - P1/2 | "ORR was 68% in pts with penta-refractory disease, and 70% in pts with prior belantamab mafodotin treatment (tx). These results support the efficacy and generally manageable safety profile of LINVO in RRMM."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Plasmacytoma