belantamab (GSK2857914) / GSK - LARVOL DELTA

Belantamab treatment of multiple myeloma: Results from part 1 of the first-in-human phase 1/2 DREAMM-20 trial. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05714839 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology

DB-1325, a BCMA-targeting antibody-drug conjugate with a Duality Unique Payload, exhibits promising efficacy and safety in preclinical multiple myeloma treatment (AACR 2025) - "DB-1325 is a novel BCMA-targeting ADC comprised of belantamab and PDUP5, a Duality Unique Payload (DUP) inhibiting mRNA translation, conjugated through a cleavable linker. A proprietary inhibitor of mRNA translation PDUP5 was discovery through a campaign of medicinal chemical design and screening. DB-1325 is a novel and promising therapy for MM and currently in preclinical development as a first-in-class ADC with mRNA translation inhibitions as its major mode of action."

IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Autoimmune Disease (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Nov 2025 ➔ Sep 2026

Trial completion date • Immunology

FIRST-LINE SALVAGE THERAPIES AFTER ANTI-BCMA CAR-T FAILURE IN PATIENTS WITH MULTIPLE MYELOMA: A META-ANALYSIS OF RESPONSE RATES (EBMT 2025) - "The following interventions have been analyzed: bispecific antibodies (bsAb) – administered in 7 studies, retreatment with anti-BCMA CAR-T cells - 5, selinexor-based regimens – 4, belantamab mafodotin – 2, iberdomide-based regimens – 2, nivolumab-based regimens - 2 studies. The response rates vary depending on the intervention used as first-line salvage treatment for MM patients after post-CAR-T progression/relapse. Infusion of bispecific antibodies provides the most robust estimate of ORR. Selinexor- and iberdomide-based regimens provide similar ORR, but with wider confidence intervals, followed by anti-BCMA CAR-T cells.On the contrary, nivolumab and belantamab mefodotin present disappointing performance."

Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

FIRST-LINE SALVAGE THERAPIES AFTER ANTI-BCMA CAR-T FAILURE IN PATIENTS WITH MULTIPLE MYELOMA: A META-ANALYSIS OF RESPONSE RATES (EBMT 2025) - "The following interventions have been analyzed: bispecific antibodies (bsAb) – administered in 7 studies, retreatment with anti-BCMA CAR-T cells - 5, selinexor-based regimens – 4, belantamab mafodotin – 2, iberdomide-based regimens – 2, nivolumab-based regimens - 2 studies. The response rates vary depending on the intervention used as first-line salvage treatment for MM patients after post-CAR-T progression/relapse. Infusion of bispecific antibodies provides the most robust estimate of ORR. Selinexor- and iberdomide-based regimens provide similar ORR, but with wider confidence intervals, followed by anti-BCMA CAR-T cells.On the contrary, nivolumab and belantamab mefodotin present disappointing performance."

Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

DREAMM-20: A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Sep 2028 ➔ Dec 2029 | Trial primary completion date: Sep 2028 ➔ Dec 2029

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

Real World Efficacy of BCMA Directed Therapies in Patients with Multiple Myeloma after Receiving Belantamab Mafodotin (TCT-ASTCT-CIBMTR 2025) - "When comparing the timing of subsequent BCMA directed therapy, no statistically significant difference was seen between BCMA therapy within 6 months (5 mos, range 3-9) and BCMA therapy ≥ 6-month post belantamab (7 mos, range 2-10) (p= 0.8) Figure 2. In patients with RRMM receiving BCMA directed BsAb or CAR T-cell therapy after failure of belantamab mafodotin, outcomes in general remain inferior compared to those without prior BCMA exposure (historical cohort). Choice of subsequent BCMA directed therapy as well as treatment free interval from BCMA exposure are not predictive of outcomes. Our findings need to be confirmed with larger studies and longer follow-up."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

Final Results of Phase 1 Clinical Trial of Belantamab Mafodotin Combined with Carfilzomib, Lenalidomide, and Dexamethasone for Multiple Myeloma after One to Three Prior Lines of Therapy (ASH 2024) - "Moreover, in the DREAMM-8 trial, Belamaf outperformed bortezomib in combination with pomalidomide and dexamethasone...50% of pts with available ISS staging data at diagnosis had stage III, 42% were refractory to lenalidomide, 11% were bortezomib refractory, 26% were double refractory, and 26% were daratumumab refractory...Conclusions : This phase 1 trial established the MTD of belantamab of 1.9 mg/kg every 8 weeks in combination with KRd...Despite the dosing schedule of every 8 week Belamaf dosing, clinically significant keratopathy was common. Pts with high-risk newly diagnosed MM will be enrolled in the phase 2 portion of this trial."

Clinical • P1 data • Cough • Fatigue • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Ophthalmology • Pain • Respiratory Diseases • Thrombocytopenia

Predictive Markers for Outcomes after Disease Progression Post BCMA-Directed CAR T-Cell Therapy in Patients with Relapsed or Refractory Multiple Myeloma (ASH 2024) - "BACKGROUND Idecabtagene vicleucel (I) and Ciltacabtagene autoleucel (C) are two commercially available BCMA-directed CAR-T cell products initially FDA approved after > 4 lines of therapy in patients with triple class exposed relapsed or refractory multiple myeloma patients (RRMM)...Treatment at progression was categorized as follows : combination therapy (CT including alkylating agents, proteasome inhibitors, immunomodulatory agents, BCL2 inhibitors, XPO1 inhibitors, monoclonal antibodies), BCMA bispecific antibody (teclistamab, elranatamab), GPRC5D bispecific antibody (talquetamab), BCMA antibody-drug conjugate (ADC) (belantamab) and clinical trial...High-risk cytogenetics and high tumor burden at the time of progression are associated with worse outcomes in these patients. The post progression use of either BCMA or GPRC5D bispecific antibody is associated with improved outcomes as compared to combination chemotherapy"

Biomarker • CAR T-Cell Therapy • Clinical • IO biomarker • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology

A Multicenter Phase 2 Study Evaluating the Optimized Schedule of Belantamab Mafodotin 1.9 Mg/Kg Q8W Plus Bortezomib and Dexamethasone in Relapsed Refractory Multiple Myeloma (ASH 2024) - P2 | "Belantamab in combination with bortezomib and dexamethasone (Vd) and belantamab in combination with pomalidomide and dexamethasone (Pd) confirmed significant benefit in PFS over daratumumab Vd and bortezomib Pd, respectively (V Hungria, NEJM 2024; MA Dimopoulos, NEJM 2024). Conclusion : The ocular findings seem to be limited due to the significantly de-escalated belantamab dosing and still the ORR reaches 64% (25/39) with MRD negativity rate of 10% (4/39). The clinical trial is ongoing, these results will have to be confirmed by the final analysis."

Clinical • P2 data • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Hepatology • Infectious Disease • Multiple Myeloma • Oncology • Ophthalmology

A Real-World Pharmacovigilance Analysis of Cardiac Adverse Events Associated with Newer Antibody-Drug Conjugates: A Disproportionality Analysis from FDA Adverse Event Reporting System Database (ASH 2024) - "Trastuzumab, one of the earliest approved ADCs for breast cancer, is known to cause cardiotoxicity, however, significant cardiac adverse events (CAEs) have not been reported with the recently approved ADCs. We aim to explore the post-marketing reports of CAEs with these medications.Methods : •Drugs of interest : We analyzed gemtuzumab, inotuzumab, polatuzumab, belantamab, and loncastuximab.•Data Source and Extraction : Data was obtained from the publicly available FDA Adverse Event Reporting System (FAERS)...Given the limited exploration in the trial data, there is a broader question of establishing causation between ADCs and CAEs. Findings of our analysis support the need for further post-marketing surveillance and potential inclusion of significant CAEs to the drug labels."

Adverse events • Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Atrial Fibrillation • B Cell Lymphoma • Breast Cancer • Cardiomyopathy • Cardiovascular • Diffuse Large B Cell Lymphoma • Heart Failure • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Myocardial Infarction • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Ventricular Tachycardia

Prior Exposure to Belantamab Mafodotin Influences Outcomes with Idecabtagene Vicluecel in Patients with Multiple Myeloma (ASH 2024) - "The incidence and severity of CRS and NT, the average number of days in the hospital and in the ICU, the need for tocilizumab, anakinra, steroids, the incidence and severity of cytopenias, and the need for stem cell boosts did not differ significantly between those with and without prior exposure to belantamab (p > 0.05). Specifically, patients who respond to belantamab exhibit inferior outcomes with ide-cel compared to those not achieving a partial or better response to belantamab. With the potential re-approval of belantamab and the increasing availability of BCMA CAR T-cell therapy, understanding the impact of previous exposure to BCMA-directed therapies is crucial for optimizing treatment selection for these patients."

Clinical • Anemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Ophthalmology • Thrombocytopenia

Efficacy and Safety of Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor T-Cell for the Treatment of Relapsed and Refractory AL Amyloidosis. (PubMed, J Clin Oncol) - P1 | "This largest clinical trial of AL patients treated with anti-BCMA CART demonstrates acceptable and manageable toxicity in a highly frail and resistant population with remarkable efficacy, leading to fast organ responses. Among patients with baseline advanced cardiac disease, deaths in the first year were frequent, suggesting that this effective therapy should be considered earlier in the course of therapy. Anti-BCMA CART may become a powerful tool for improving organ function and survival in patients with AL."

CAR T-Cell Therapy • Journal • Amyloidosis • Heart Failure • Hematological Disorders • Inflammation

Real-World Characteristics, Step-up Dosing Patterns, and Outcomes in Patients with Multiple Myeloma Receiving Teclistamab at Texas Oncology Community-Based Treatment Centers (ASH 2024) - "Of the 2 pts (13%) with prior BCMA exposure, both received belantamab; the median time from belantamab to teclistamab initiation was 17.5 months (range : 16.2-18.8).Six pts (40%) received SUD in a TxO outpatient facility; nine (60%) were referred outside of TxO for SUD, all of whom returned to TxO for the first treatment dose...No pts received primary prophylactic tocilizumab for CRS...Nonetheless, these initial outcomes support the feasibility of administering teclistamab using a community-based approach, which is important to ensure access for pts in need of novel therapies. This analysis will be updated with more pts and longer follow-up."

Clinical • Real-world • Real-world evidence • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Pain • Renal Disease

Dexamethasone Is Associated with Cataracts in Multiple Myeloma Even after Adjusting for Age: Results of a Large Cross-Sectional Survey (ASH 2024) - "Introduction : Many multiple myeloma (MM) therapies can increase the risk of ocular comorbidities such as bortezomib-related blepharitis or belantamab-related keratopathy. Future research is in development to prospectively investigate whether dex reduction strategies can mitigate this longitudinal risk of cataracts. More broadly, our findings suggest that periodic eye exams - although inconsistently recommended by oncologists - are a key component of supportive care for patients living with MM.Funding : HealthTree Foundation through patient donations."

Cataract • Dry Eye Disease • Glaucoma • Hematological Malignancies • Multiple Myeloma • Ocular Inflammation • Oncology • Ophthalmology

Treatment Modalities and Outcomes of Multiple Myeloma Patients with Spinal Cord Compression: A Single Center Experience (ASH 2024) - "9 pts received proteasome inhibitors (PIs) based therapy (8 bortezomib and 1 carfilzomib), 2 pts received chemotherapy (one combined with PIs), and 1 patient each was treated with daratumumab and belantamab. Newly diagnosed pts presenting with SCC have similar OS compared with their "non-SCC" counterparts, whereas pts with SCC event at the time of relapse appear to have dismal prognosis. Failure to achieve a favorable neurological outcome is associated with decreased survival, emphasizing the need for larger clinical trials to guide optimal management and decision-making."

Clinical • Anemia • Cardiovascular • CNS Disorders • Congestive Heart Failure • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Hematological Malignancies • Infectious Disease • Mucositis • Multiple Myeloma • Neutropenia • Oncology • Orthopedics • Pain • Plasmacytoma • Thrombocytopenia

NOVEL DRUG COMBINATIONS AND DONOR LYMPHOCYTE INFUSIONS ALLOW PROLONGED DISEASE CONTROL IN MULTIPLE MYELOMA PATIENTS RELAPSING AFTER ALLOGENEIC TRANSPLANT: New treatments for Multiple Myeloma patients relapsing after Allo transplant. (PubMed, Transplant Cell Ther) - "In our study, patients transplanted in early phases of disease and with HLA identical sibling donors had the best chance of long-term survival. Late relapse after allo-SCT, multiple courses of salvage treatment and the association with DLI could allow long disease control in patients who experienced relapse after allo-SCT."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • Transplantation

DREAMM-20: A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: GlaxoSmithKline | N=124 ➔ 48 | Trial completion date: Feb 2028 ➔ Sep 2028 | Trial primary completion date: Sep 2027 ➔ Sep 2028

Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Real World Single Centre Experience On The Use of Radiotherapy In The Treatment of Patients with Multiple Myeloma (IMW 2024) - "Median number of treatment lines was 4 (range 1-9) with 90.7% of patients exposed to bortezomib, 84.1% lenalidomide, 47.7% pomalidomide, 34.4% daratumumab, 30.5% ixazomib, 20.5% carfilzomib, 13.2% isatuximab, 12.6% belantamab, and 2.6% CAR-T/bispecific antibodies (BsAbs). This single centre study involving patients on contemporary treatment protocols showed that RT was used mainly at subsequent therapy lines rather than at diagnosis and was predominantly used as a pain relief measure. An important observation was the low incidence of repeat irradiation at previous RT sites, suggesting the radiosensitive nature of MM. RT could continue to hold a role in patients who become refractory to systemic therapy as salvage bridging therapy especially in the era of CAR-T and BsAbs."

Clinical • Real-world • Real-world evidence • CNS Disorders • Hematological Malignancies • Multiple Myeloma • Musculoskeletal Diseases • Musculoskeletal Pain • Oncology • Orthopedics • Pain • Plasmacytoma

Novel selinexor triplet and quadruplet regimens (SNd, SPEd, SBd, SDPd): Results from the Phase 1b/2 STOMP multiple myeloma trial (IMW 2024) - P1/2 | "Selinexor (S), a first-in-class oral XPO1 inhibitor approved in combination with dexamethasone (Sd) in penta-refractory MM and with dexamethasone + bortezomib (SVd) in relapsed/refractory MM (RRMM) after ≥1 therapy, has shown synergy with other anti-cancer treatments and is being investigated in several novel regimens in the STOMP phase 1b/2 trial (NCT02343042). Here we report safety and efficacy from 4 arms: S 60-80 mg QW + ixazomib (N) 4 mg QW + d (SNd); S 40 mg QW + pomalidomide (P) 4 mg QD + elotuzumab (E) 10 mg/kg QW + d (SPEd); S 60 mg QW + belantamab (B) 2.5 mg/kg Q3W + d (SBd); and S 40 mg QW + daratumumab (D) 16 mg/kg QW + P 4 mg QD + d (SDPd)... Selinexor was evaluated in a limited number of pts with various partner drugs. The majority of pts tolerated the selinexor regimens at the intended dosing. No increase in partner drug toxicities were observed, which aligns with the combinability profile of S + d with carfilzomib (SKd), P (SPd), and D (SDd) in the..."

P1/2 data • Fatigue • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Ophthalmology

Real-world outcomes of teclistamab for the treatment of relapsed/refractory multiple myeloma at UC San Diego Health: A single-institution experience (IMW 2024) - "Extramedullary plasmacytomas were present in 48% of patients at time of teclistamab initiation; 32% had received prior BCMA therapy (2 belantamab, 6 idecabtagene vicleucel) before teclistamab...Cytokine release syndrome (CRS) occurred in 17 patients (68%), (3 (18%) grade 2, no grade 3-5); 8 (47%) received tocilizumab... Overall, the incidence and grades of CRS, ICANS, and infection in our cohort were similar to those observed in the phase I/II MajesTEC-1 trial. The ORR was also comparable. In contrast, the PFS in this study was lower compared to the MajesTEC-1 study."

Clinical • IO biomarker • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology • Pain • Plasmacytoma

Results of a phase 1 clinical trial of belantamab mafadotin (BelMaf) combined with carfilzomib, lenalidomide, and dexamethasone (KRd) for multiple myeloma (MM) after one prior line of therapy (LOT) (IMW 2024) - "50% of pts with available staging data had stage III MM and 42%, 11%, 26%, and 26% were refractory to lenalidomide, bortezomib, double refractory, and daratumumab, respectively. The MTD and RP2D of BelMaf with KRd was 1.9 mg/kg every 8 weeks. KRd-BelMaf demonstrated deep responses in pts with high-risk features, including HRCGs and R refractory disease. Keratopathy was frequent but manageable with dose delays and reductions."

Clinical • P1 data • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Ophthalmology • Pain • Thrombocytopenia

Development and preclinical evaluation of a novel radioimmunoconjugate targeting BCMA in multiple myeloma. (EANM 2024) - "[89Zr]Zr-DFO*-Belantamab was successfully produced and showed favorable stability and binding affinity, supporting further validation as a potential novel immunoPET imaging agent of BCMA expression for in vivo studies."

IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Moderate to Severe Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Real-world outcomes of teclistamab for the treatment of relapsed/refractory multiple myeloma at UC San Diego Health: A single-institution experience. (ASCO 2024) - "Approximately 44% of patients had extramedullary plasmacytomas at time of BsAb initiation; 39% had received prior BCMA therapy (2 belantamab, 5 ide-cel) before teclistamab...6 (50%) received tocilizumab to treat CRS... Overall, the incidence and grades of CRS, ICANS, and infection in our cohort were similar to those observed in the phase I/II MajesTEC-1 trial. In contrast, the ORR and PFS in this study were lower compared to the MajesTEC-1 study. This difference may be due to a greater proportion of patients with high-risk cytogenetics and more aggressive disease, as depicted by the higher median prior lines of therapy and higher rates of extra-medullary plasmacytomas and triple-/penta-class refractory disease."

Clinical • IO biomarker • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Pain • Plasmacytoma