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

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 plus lenalidomide/dexamethasone in newly diagnosed intermediate-fit & frail multiple myeloma patients: Long-term efficacy and safety from the phase 1/2 BELARD clinical trial. (ASCO 2025) - P1/2 | "As has also been shown in the DREAMM-7/-8 studies, belamaf exhibits substantial clinical activity, with rapid, deep & durable responses in an unfit pt population, with only 2 PDs observed after a median of ~2 years FU. Only a few high-grade OAEs were recorded, that resolved quickly & no new safety signals were observed. Moving forward, the BelaRd combination, with the extended belamaf dosing schedule, warrants further investigation in larger pt numbers."

Clinical • P1/2 data • CNS Disorders • Fatigue • Hematological Malignancies • Infectious Disease • Insomnia • Multiple Myeloma • Oncology • Ophthalmology • Pneumonia • Respiratory Diseases • Sleep Disorder

COSTA: A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed/Refractory Myeloma (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Cristiana Costa Chase, DO | Trial completion date: Oct 2027 ➔ Jun 2028 | Trial primary completion date: Oct 2025 ➔ May 2028

Trial completion date • Trial primary completion date • Breast Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • CD4

Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant (clinicaltrials.gov) - P2 | N=4 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Suspended ➔ Active, not recruiting | N=20 ➔ 4

Enrollment change • Enrollment closed • Minimal residual disease • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Antibody-Drug Conjugates, T-Cell Engager Bispecific Antibodies and Chimeric Antigen Receptor T Cells for Multiple Myeloma: What's the Current Status? (PubMed, Target Oncol) - "This has resulted in European Medicines Agency and US Food and Drug Administration approval of agents targeting the B-cell maturation antigen: antibody-drug conjugate belantamab mafodotin (belantamab), bispecific T-cell engaging antibodies teclistamab, elranatamab and linvoseltamab, and chimeric antigen receptor T-cell products idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel). Talquetamab, a bispecific T-cell engaging antibody targeting G protein coupled receptor family C group 5 member D has also been approved by the European Medicines Agency and Food and Drug Administration. With increasing availability of these agents, knowledge on the efficacy and safety of these novel treatments will be essential for future multiple myeloma care. In this narrative review, we discuss the pivotal trials, current real-world evidence and recent insights in the mechanisms of resistance of antibody-drug conjugates, bispecific T-cell engaging antibodies and..."

Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Blenrep: Regulatory decision in China for 2L+ multiple myeloma (based on DREAMM-7 trial) in H1 2026 (GSK) - Q4 2025 Results: Acceptance of regulatory submission and decision in China for 2L+ multiple myeloma (based on DREAMM-8 trial) in H2 2026 and 2027

China approval • China filing • 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

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

Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=62 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: May 2027 ➔ Jun 2034 | Trial primary completion date: May 2026 ➔ Jun 2029

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

Selinexor-Based Regimens in Patients with Multiple Myeloma after Prior Anti-B-Cell Maturation Antigen Treatment (ASH 2021) - P1b/2 | "X is approved with bortezomib (V) and dexamethasone (XVd) in patients (pts) with at least 1 prior therapy and is not associated with known long-term clinically significant toxicities such as visual loss, cardiac dysfunction, renal failure, neuropathy, irreversible bone marrow suppression, second malignancies, venous thromboembolism, or rash...Here we report on all pts in STOMP with prior anti-BCMA treatment who were treated on STOMP with X+pomalidomide +dexamethasone (XPd); XVd; X+carfilzomib+d (XKd); XPVd; and XPd+elotuzumab (E) (XPEd). Results In total, 11 pts with prior anti-BCMA therapy (6 pts with belantamab mafodotin; 1 each with MEDI2228, SEA-BCMA, BCMA BITE; 2 with idecabtagene vicleucel) were treated with 5 X-containing regimens (Table 1): 9 pts were treated with triplets XPd (4), XVd (3), or XKd (2) and 2 pts with quadruplets XPVd (1) or XPEd (1)...Conclusions In this follow-up cohort of heavily pretreated pts, a majority of whom with MM refractory to..."

Clinical • Cardiovascular • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Oncology • Pain • Renal Disease • Thrombocytopenia • Venous Thromboembolism

Effectiveness of anti-B-cell maturation antigen (BCMA)-targeting therapy after selinexor treatment. (ASCO 2023) - P1b/2, P2b, P3 | " We analyzed the effectiveness of non-cellular αBCMA (NCA) therapies in pts with MM treated in 4 clinical studies (STORM [NCT02336815]; STOMP [NCT02343042]; BOSTON [NCT03110562], XPORT-MM-028 [NCT04414475]) with selinexor + dexamethasone (Xd), with or without PIs, IMiDs, or αCD38 mAbs, followed by therapy with NCA...Thirty-seven pts (median age: 68, range: 40-87) received NCA therapy at any time following a selinexor regimen (Xd, n = 12; Xd + bortezomib, n = 9; Xd + pomalidomide, n = 6; Xd + daratumumab, n = 3; Xd + carfilzomib, n = 5; Xd + ixazomib, n = 2). NCAs included the ADC belantamab mafodotin (n = 28), the BiS teclistamab (n = 2), SEA-BCMA (n = 2), AMG 701 (n = 1), elranatamab (n = 1), MEDI2228 (n = 1), and investigational (n = 3; 2 had αBCMA bispecific antibodies and 1 had αBCMA BITE) (1 pt received 2 NCAs, belantamab and teclistamab)... In this cohort of heavily-pretreated pts with MM who received a selinexor regimen prior to NCA, overall..."

Hematological Malignancies • Immune Modulation • Multiple Myeloma • Oncology

Salvage Therapies After Anti-BCMA CAR-T Failure in Patients With Multiple Myeloma: A Meta-Analysis of Response Rates. (PubMed, Eur J Haematol) - "In the first-line setting, selinexor-based regimens yielded the highest overall response rates (ORR) of 67% (95% CI: 38%-91%), followed by bsAbs (60%; 95% CI: 43%-76%). In the combined setting, anti-GPRC5D CAR-T cells achieved the highest ORR (88%; 95% CI: 65%-100%), followed by anti-BCMA CAR-T cells (75%; 95% CI: 42%-98%). Belantamab mafodotin demonstrated the lowest efficacy (0%; 95% CI: 0%-17%)...In summary, our meta-analysis suggested that CAR-T cells and bsAbs are suitable for salvage use after anti-BCMA CAR-T failure in MM. Trial Registration: PROSPERO number: CRD42024621077."

Journal • Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

Belantamab mafodotin, pomalidomide and dexamethasone in refractory multiple myeloma: a phase 1/2 trial. (PubMed, Nat Med) - P1/2 | "The two-part ALGONQUIN trial evaluated various doses and schedules of the anti-BCMA antibody-drug conjugate belantamab mafodotin plus pomalidomide and dexamethasone for patients who are lenalidomide refractory and proteosome inhibitor exposed. Belantamab mafodotin plus pomalidomide and dexamethasone induced durable responses with promising overall survival in relapsed multiple myeloma, the results of which are yet to be confirmed in the phase 3 DREAMM-8 study. ClinicalTrials.gov Identifier: NCT03715478 ."

Journal • P1/2 data • Fatigue • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Ophthalmology • Thrombocytopenia

Results from Arm A of Phase 1/2 DREAMM-6 trial: belantamab mafodotin with lenalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma. (PubMed, Blood Cancer J) - No abstract available

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

Clinical Outcomes of Subsequent Therapies in Patients with Relapsed/Refractory Multiple Myeloma Following Talquetamab Treatment: Analyses from the Phase 1/2 MonumenTAL-1 Study (ASH 2023) - P1, P2 | "In the QW and Q2W cohorts, respectively, 74.1% and 69.0% were triple-class refractory, 29.4% and 23.4% were penta-drug refractory, and 15.4% and 11.0% had prior belantamab mafodotin exposure. Pts from MonumenTAL-1 who discontinued tal were effectively treated with several classes of therapy. Subsequent treatment with T-cell redirection therapies appears feasible, with 25.0% of pts achieving a complete response or better with CAR-T therapy post tal. Further investigation in larger pt populations is warranted to better understand the sequencing of T-cell redirecting therapies after tal to optimize outcomes."

Clinical • Clinical data • P1/2 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Psychiatry

A phase 3, open-label, randomized study to evaluate the efficacy and safety of single-agent belantamab mafodotin (belamaf) compared to pomalidomide plus low-dose dexamethasone (Pd) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): DREAMM‑3. (ASCO 2023) - P2, P3 | "Belamaf monotherapy did not demonstrate PFS superiority when compared to a doublet (Pd). However, median PFS was longer for belamaf monotherapy and belamaf induced deeper, more durable responses than Pd. No new safety signals were observed."

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

Safety and clinical activity of belantamab mafodotin plus lenalidomide and dexamethasone in transplant ineligible patients with newly diagnosed multiple myeloma: The phase 1/2, prospective, open-label, BelaRd study. (ASCO 2023) - P1/2 | "Part 1 of the BelaRd study showed that in TI pts with NDMM, the safety profile of belamaf plus Rd was manageable and a meaningful BCVA decline was noted in a minority ( < 10%) of assessments which resolved quickly (1 month). The combination induced rapid and deep responses, with all pts achieving ≥PR and first response observed at a median of 1 month. Clinical trial information: NCT04808037."

Clinical • P1/2 data • Dry Eye Disease • Fatigue • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Ophthalmology • Thrombocytopenia • Transplantation

COMPARISON OF TECLISTAMAB WITH BELANTAMAB MAFODOTIN IN PATIENTS WITH TRIPLE-CLASS EXPOSED RELAPSED/REFRACTORY MULTIPLE MYELOMA USING MATCHING-ADJUSTED INDIRECT TREATMENT COMPARISON (EHA 2022) - P2 | "Conclusion In this comparative analysis, tec showed statistically improved DOR when compared with belamaf and numerically favorable results for other outcomes. This highlights the potential of tec as a treatment option for patients with TCE RRMM who received ≥3 prior lines of therapy."

Clinical • IO biomarker • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Oncology

A Phase 1/2, Dose and Schedule Evaluation Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin Administered in Combination with Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma (ASH 2022) - P1/2 | "The belamaf Rd combination induced rapid and deep hematological responses, with almost all (97.2%) pts achieving at least PR and first response observed at a median of 1.0 months. The selected belamaf RP2D dose was 1.9 mg/kg."

Clinical • Combination therapy • P1/2 data • Fatigue • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Ophthalmology • Thrombocytopenia • Transplantation

Phase I Study of Belantamab Mafodotin in Combination with Standard of Care in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Dreamm-9 Updated Interim Analysis (ASH 2024) - P1 | "Introduction DREAMM-9 (NCT04091126) is an ongoing randomized Phase 1 dose optimization study evaluating belantamab mafodotin (belamaf) plus bortezomib, lenalidomide, and dexamethasone (VRd) in autologous stem cell transplant (ASCT)-ineligible newly diagnosed multiple myeloma (TI NDMM). Across the cohorts, ocular events were effectively managed with dose holds/reductions maintaining patients on treatment. These data are consistent with prior clinical studies of belamaf in the relapsed/refractory setting."

Combination therapy • P1 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Ophthalmology • Pneumonia • Respiratory Diseases • Thrombocytopenia • Transplantation

Results from the randomized phase 3 DREAMM-8 study of belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide plus bortezomib and dexamethasone (PVd) in relapsed/refractory multiple myeloma (RRMM). (ASCO 2024) - P3 | "In DREAMM-7, BVd led to a significant improvement in progression-free survival (PFS) and a strong trend in improved overall survival (OS) vs daratumumab-Vd in patients (pts) with ≥1 prior therapy... DREAMM-8 is a phase 3, open-label, randomized, multicenter trial evaluating the efficacy and safety of BPd vs PVd in RRMM pts who received ≥1 prior line of therapy (LoT), including lenalidomide... The DREAMM-8 study demonstrated a statistically significant and clinically meaningful PFS benefit with BPd vs PVd in RRMM with >1 prior LoT. BPd also led to deeper and more durable responses, showed a favorable OS trend, and had a manageable safety profile."

Clinical • Late-breaking abstract • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology

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

Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial. (PubMed, Lancet Haematol) - P3 | "HRQOL was generally maintained or improved over time with belantamab mafodotin, bortezomib, and dexamethasone treatment. Our findings, in conjunction with previously reported clinical benefits, support the use of belantamab mafodotin as a potential new standard of care in relapsed or refractory multiple myeloma."

Journal • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology

Belantamab Mafodotin in Combination with VRd for the Treatment of Newly Diagnosed Transplant Eligible Multiple Myeloma Patients: Results from the Phase II, Open Label, Multicenter, GEM-BELA-VRd Trial (IMW 2024) - "Introduction: GEM-BELA-VRd is a phase II, open label, multicenter, non-randomized single arm clinical trial evaluating belantamab mafodotin (belamaf) plus bortezomib, lenalidomide, and dexamethasone (VRD) in transplant-eligible newly diagnosed multiple myeloma (TE NDMM) patients (pts). Belamaf-VRD resulted in manageable eye-related AEs, expected hematological toxicity and respiratory infections, also due to the impact of the COVID -19 pandemic during trial recruitment. Besides, this combination was effective with a deepening of the response over time in TE NDMM."

Clinical • Combination therapy • Late-breaking abstract • P2 data • Bone Marrow Transplantation • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Novel Coronavirus Disease • Oncology • Plasmacytoma • Respiratory Diseases • Septic Shock • Thrombocytopenia • Transplantation

DREAMM-7 update: Subgroup analyses from a phase 3 trial of belantamab mafodotin (belamaf) + bortezomib and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in relapsed/refractory multiple myeloma (RRMM). (ASCO 2024) - P3 | "At baseline, 79 pts (33%) in the BVd arm and 87 pts (35%) in the DVd arm were refractory to lenalidomide (LEN). In DREAMM-7 BVd demonstrated PFS benefit over DVd with an mPFS improvement of 23 mo in pts with RRMM and ≥1 prior LOT. These results, demonstrating efficacy benefit in key subgroups with a high unmet need, support BVd as a potential new SOC in this setting."

P3 data • Hematological Malignancies • Multiple Myeloma • Oncology