RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), PRIME (European Union), Breakthrough Therapy (China), Orphan Drug (Japan), Priority Review (China)

Structure/Sequence

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Sequence Code 33466H

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Sequence Code 33489L

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Clinical Trials associated with Belantamab mafodotin

NCT05874193

/ Not yet recruitingPhase 2IIT

A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed/Refractory Myeloma

This is a research study to find out if a drug called belantamab mafodotin in combination with dexamethasone, a steroid, can be safely and effectively given in the community setting. Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval. In November 2022, belantamab mafodotin was removed from the market because a study to further confirm its activity in relapsed/refractory multiple myeloma did not deliver a supporting result. However, this confirmatory study demonstrated that some patients may still benefit from treatment with belantamab mafodotin, and that this benefit can be long lasting. Belantamab mafodotin is often given at large academic medical centers every 3 weeks. This study will assess whether it is possible to administer belantamab in the community setting every 6 weeks. It is unknown if administering belantamab every 6 weeks versus every 3 weeks will result in improved safety and/or reduced efficacy.

Start Date01 Oct 2025

Sponsor / Collaborator

Duke University

NCT07019545

/ Not yet recruitingPhase 2IIT

A PHASE II TRIAL AIMING TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN IN ADULT PATIENTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA PREVIOUSLY TREATED WITH A THROMBOPOIETIN RECEPTOR AGONIST AND/OR RITUXIMAB AFTER CORTICOSTEROID FIRST-LINE THERAPY

This is a Phase II open label, prospective, multicenter trial designed to assess the safety and clinical activity of belantamab mafodotin in adult patients with primary immune thrombocytopenia (ITP) previously treated with a thrombopoietin receptor agonist (TPO-RA) and/or rituximab after first-line treatment with corticosteroids. Overall, 14 participants will be enrolled in the trial. Participants' follow-up will continue for up to 12 months after the last participant is enrolled. The accrual period will be approximately 12 months.
Trial treatment will be given in 28-day cycles for a total period of one year per patient or until treatment failure, physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). Participants without confirmed Response (R) or better after two infusions with belantamab mafodotin will be discontinued from trial treatment and will not be replaced.

Start Date20 Jun 2025

Sponsor / Collaborator

Hellenic Society of Cardiology

NCT06232044

/ SuspendedPhase 1/2IIT

A Phase I/II Study of the Safety, Tolerability and Efficacy of Belantamab Mafodotin (GSK2857916) in Combination With Iberdomide (CC-220)/Dexamethasone Versus Belantamab Mafodotin (GSK2857916)/Dexamethasone in Relapsed Refractory Multiple Myeloma

This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.

Start Date23 Apr 2025

Sponsor / Collaborator

Alliance for Clinical Trials in Oncology

[+1]

100 Clinical Results associated with Belantamab mafodotin

100 Translational Medicine associated with Belantamab mafodotin

100 Patents (Medical) associated with Belantamab mafodotin

303

Literatures (Medical) associated with Belantamab mafodotin

01 Aug 2025·Blood Neoplasia

Belantamab mafodotin in patients with relapsed/refractory multiple myeloma: a real-world experience

Article

Author: Tan, Carlyn R ; Shah, Urvi A ; Korde, Neha ; Lesokhin, Alexander M ; Firestone, Ross S ; Mailankody, Sham ; Shekarkhand, Tala ; Nemirovsky, David ; Chung, David J ; Derkach, Andriy ; Usmani, Saad Z ; Akhlaghi, Theresia ; Shah, Gunjan L ; Maclachlan, Kylee ; Landau, Heather J ; Giralt, Sergio A ; Scordo, Michael ; Patel, Dhwani ; Hassoun, Hani ; Lahoud, Oscar B ; Hultcrantz, Malin

Belantamab mafodotin is an antibody-drug conjugate targeting B-cell maturation antigen (BCMA) for the treatment of multiple myeloma. To evaluate the efficacy and safety of belantamab mafodotin in a real-world setting in the United States, we assessed all patients treated with commercial belantamab mafodotin at the Memorial Sloan Kettering Cancer Center between 2020 and 2023. Ninety-four patients were identified; 57 had high-risk cytogenetics, 77 were triple-class refractory, the median prior lines of therapy was 6, and 18 patients had received prior BCMA-targeted treatment. The overall response rate (ORR) was 43%, and 21% achieved a very good partial response or better. The median progression-free survival (PFS) was 3.8 months, median overall survival (OS) was 17.2 months, and the median duration of response was 10.5 months. In patients with prior BCMA exposure (median prior lines of therapy = 9), the ORR was 29%, PFS was 2 months, and OS was 20.4 months. Sixty-one patients (65%) had any grade of ocular toxicity and 15 patients had grade 3 or more keratopathy. All keratopathy was reversible and resolved or reduced to grade 1 by the end of the follow-up. Most patients could continue on a reduced dose or with a longer dose interval while maintaining the clinical response. Eighteen patients had 1 or more infections, most of which were grade 1/2. In summary, belantamab mafodotin showed significant ORR, including those of patients with prior BCMA exposure. Ocular toxicity was similar to that in previous reports, and the risk of serious infections was low in this cohort of heavily pretreated patients with multiple myeloma.

01 Aug 2025·Clinical Lymphoma Myeloma & Leukemia

Treatment Patterns, Efficacy, and Tolerability of Belantamab Mafodotin in Patients With Relapsed and/or Refractory Multiple Myeloma: A Real-World Analysis

Article

Author: Falvey, Caroline ; Costa Chase, Cristiana ; Bolgioni-Smith, Amanda ; Gasparetto, Cristina ; Herring, Kris W ; Newman, Mark S ; Iadeluca, Laura ; Patel, Mihir N ; Troy, Jesse D ; Elcock, Cherie ; Locke, Susan C ; LeBlanc, Thomas W

PURPOSE:

Belantamab mafodotin is an anti-B cell maturation antigen (BCMA) immunoconjugate for patients with relapsed/refractory multiple myeloma (RRMM). Additional data on its treatment patterns, efficacy, and tolerability in real-world settings are needed.

PATIENTS AND METHODS:

This single-site, retrospective study examined 30 adults with multiple myeloma receiving care at Duke Cancer Institute who began belantamab mafodotin monotherapy between 8/5/2020 and 11/22/2022. We described baseline clinical characteristics, disease response (per International Myeloma Working Group [IMWG] criteria, as possible given available bone marrow biopsy data), belantamab mafodotin treatment patterns, and ocular adverse events (per the Keratopathy Visual Acuity [KVA] scale).

RESULTS:

Across 30 patients, the median number of lines of therapy was 4, 20 patients (87%) were triple-/quad-/penta-refractory, and 7 (23%) had high-risk cytogenetics (per IMWG criteria). Overall response rate was 67%. Progression occurred in 22 patients (73%); median progression-free survival was 9.5 months (95% CI 6.6-15.6). Median overall survival was not reached as of 3-year follow-up. Dose reduction occurred in 19 patients (63%); 65% were due to ocular adverse events, 30% hematologic adverse events. Cycle delay occurred in 28 (93%); 85% were due to ocular adverse events. Keratopathy (any grade) occurred in 28 (93%); 2% of events were grade ≥3. Visual acuity change (any grade) occurred in 27 (90%); 3.3% of events were grade ≥3. Treatment discontinuation from ocular toxicity occurred in 4 (13%).

CONCLUSION:

Despite a high incidence of manageable keratopathy, these data demonstrate benefit in belantamab mafodotin in patients with RRMM over an extended time amid dose/cycle modifications.

REGISTRATION:

CLINICALTRIALS.GOV: NCT05986682.

01 Aug 2025·ESMO Open

A network meta-analysis of randomized clinical trials in lenalidomide-exposed or -refractory multiple myeloma patients

Article

Author: Morabito, F ; Neri, A ; Lucia, E ; Martino, E A ; Mendicino, F ; Olivito, V ; Bruzzese, A ; Vigna, E ; Caridà, G ; Labanca, C ; Lofaro, D ; Puccio, N ; Amodio, N ; Gentile, M

BACKGROUND:

The treatment landscape for relapsed/refractory multiple myeloma (RRMM) is rapidly evolving, particularly for patients exposed or refractory to lenalidomide. With the aim of evaluating the relative efficacy of lenalidomide-free regimens as second-line treatment options, an updated network meta-analysis, incorporating phase II/III randomized controlled trials, has been conducted.

MATERIALS AND METHODS:

A systematic literature search identified eight eligible trials comprising 3952 patients. The primary outcome was progression-free survival (PFS), analyzed through Bayesian and frequentist approaches.

RESULTS:

Our findings indicate that belantamab mafodotin, bortezomib, and dexamethasone (BVd) combination is the most effective regimen for both lenalidomide-exposed and lenalidomide-refractory MM patients at first relapse, achieving the highest surface under the cumulative ranking curve for PFS. BVd outperformed other triplet regimens, including daratumumab, bortezomib, and dexamethasone, isatuximab, carfilzomib, and dexamethasone, and bortezomib, pomalidomide, and dexamethasone.

CONCLUSIONS:

Emerging therapies, including chimeric antigen receptor T-cell (CAR-T-cell) therapy and bispecific antibodies, are set to reshape RRMM treatment paradigms. Trials such as CARTITUDE-4 and MajesTEC-3 are exploring these agents in earlier treatment lines, particularly for lenalidomide- and daratumumab-refractory patients. Our analysis provides an evidence-based hierarchy of lenalidomide-free regimens, supporting BVd as a preferred second-line treatment. Future studies should refine treatment sequencing strategies and evaluate novel agents in earlier disease stages to optimize outcomes for RRMM patients.

162

News (Medical) associated with Belantamab mafodotin

28 Jul 2025

·www.fiercepharma.com

Another FDA mini-pause for Bayer’s menopause candidate?

Drug approval delays have become more common since the FDA lost 19% of its workforce in April due to federally mandated budget cuts. After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet drug approval deadlines. The latest example is its failure to rule on Bayer’s menopause treatment, elinzanetant.On Friday, the German company said in a release that the FDA needed additional time to review its new drug application for elinzanetant, extending the Prescription Drug User Fee Act (PDUFA) review period by up to 90 days.The FDA was expected to make its decision by Saturday on the application, which was filed in August 2024. The new PDUFA date is Oct. 26.Bayer added that the FDA did not “raise any concern regarding the general approvability” of elinzanetant. Earlier this month, regulators in the U.K. endorsed the treatment, which is known commercially as Lynkuet. Canada followed suit last week with a thumbs-up, while a review is ongoing by the European Union.“We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval,” Yesmean Wahdan, M.D., Bayer’s head of medical affairs in North America, said in a statement. “We continue to work with the FDA to make this treatment available.”Analysts at Barclays wrote that the delay was a “small negative” for Bayer, which has tabbed peak sales for the treatment at 1 billion euros ($1.2 billion). The company will likely add more details during its second-quarter earnings presentation on Aug. 6.Over the past four months, the FDA has delayed its review of several drugs, but most decisions have still arrived relatively quickly. In May, the agency approved GSK’s Nucala for COPD less than two weeks after its original PDUFA date.In July, the FDA signed off on KalVista’s rare disease drug Ekertly three weeks after its original PDUFA date. And in April and May, it took an extra six weeks to convert Novavax’s COVID-19 vaccine from accelerated to full approval. In May, the FDA took an extra month to reject a rare-disease drug from Stealth BioTherapeutics, though that application has been through a series of regulatory challenges since the Massachusetts company first presented data in 2019.Last week, the FDA also delayed a decision on GSK’s multiple myeloma drug Blenrep by 90 days, which was voted down as an agent in two separate combinations by an FDA advisory committee earlier this month.As for Bayer, it is hoping to join Astellas as the second company with a hormone-free treatment for patients with moderate to severe hot flashes that accompany menopause. While Astellas’ Veozah was the first neurokinin 3 (NK-3) receptor antagonist approved for the indication, Lynkuet is the first dual-action neurokinin in the indication, targeting the NK-3 and NK-1 receptors. Astellas reported 2024 fiscal year sales of Veozah at 33.8 billion yen ($230 million), which came up short of its expectations. Astellas has projected fiscal 2025 sales at 50 billion yen ($340 million). The company's peak sales projection for the treatment, which carries a black box warning for potential liver damage, is $3.6 billion.Despite being from the same treatment class, Lynkuet has shown scant evidence of the side effects in three phase 3 trials.

Drug ApprovalPhase 3VaccineClinical ResultAccelerated Approval

25 Jul 2025

·pipelinereview.com

Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma

LONDON, UK I July 24, 2025 I GSK plc (LSE/NYSE: GSK) today announced the approval of Blenrep in the European Union (EU) for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. The approval is based on superior efficacy results demonstrated by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma. These include statistically significant and clinically meaningful progression-free survival (PFS) for Blenrep combinations versus triplet standard of care combinations in both trials and overall survival (OS) versus a daratumumab-based triplet in DREAMM-7. 2,3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents. 2,3 Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, sai d: “Today’s approval of Blenrep combinations is a redefining moment for patients with relapsed or refractory multiple myeloma in the EU. Blenrep has the potential to extend remission and survival, with superior efficacy versus standards of care in our DREAMM clinical trial programme and the option to administer in both academic and community-based settings.” More than 50,000 cases of multiple myeloma are diagnosed in Europe each year, accounting for more than a quarter of global incidence. 5 Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) approved in multiple myeloma, providing patients with a differentiated mechanism of action to potentially help slow disease progression and extend survival. 1 Blenrep combinations can be administered to a range of patient types across oncology treatment settings, enabling broad accessibility of an anti-BCMA therapy. María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit, Haematology Department and Professor of Medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, said : “With the approval of Blenrep combinations in the EU, we now have additional tools in our efforts to keep patients in remission longer, maintain quality of life and extend survival. The robust efficacy supported by the DREAMM-7 and DREAMM-8 trials, together with manageable outpatient administration in academic and community settings, positions Blenrep combinations as a fundamentally differentiated treatment approach for multiple myeloma patients starting from first relapse.” Both DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the Blenrep combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma. 2,3 In DREAMM-7, the Blenrep combination (n=243) nearly tripled median PFS versus the daratumumab-based comparator (n=251) (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001). 2 DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring the Blenrep combination versus the daratumumab-based comparator (HR: 0.58; 95% CI: 0.43-0.79; p=0.00023). The median OS was not reached in either arm of the study. The three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab combination arm. 4 In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the Blenrep combination compared to 12.7 months in the bortezomib combination (95% CI: 9.1-18.5) at the time of primary analysis. 3 Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators. 2,3 DREAMM-7 and DREAMM-8 showed that eye-related side effects associated with Blenrep can be managed and reversed with appropriate dose modifications and follow-up. This allowed patients to maintain benefit and resulted in low rates of discontinuation due to eye-related side effects (≤9%) in both trials. 2,3 The most commonly reported non-ocular adverse events (>30% of participants) in the Blenrep combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in DREAMM-8. 2,3 Blenrep combinations are also approved in relapsed or refractory multiple myeloma in the UK 6 and Japan 7 as well as other markets, including Canada and Switzerland (based on the results of DREAMM-8). Applications are currently under review in all major markets globally, including the US 8 and China 9 (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application). About multiple myeloma Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. 10,11 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. 5 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. 1 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre. 12,13 About Blenrep Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group. Indication In the EU, Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma: IMPORTANT SAFETY INFORMATION FOR BLENREP Refer to the Blenrep EMA Reference Information 14 which will soon be available for a full list of adverse events and the complete important safety information in the EU. About DREAMM-7 DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks in combination for the first eight cycles and then continued as a single agent. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes. PFS results were presented at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024 and published in the New England Journal of Medicine . OS results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2024. 2,4 About DREAMM-8 DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and then 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes. Results were first presented at the 2024 ASCO Annual Meeting and published in the New England Journal of Medicine . 3 Updated PFS results were presented at the European Hematology Association (EHA) Congress in June 2025. 15 GSK in oncology Our ambition in oncology is to help increase overall quality of life, maximise survival and change the course of disease, expanding from our current focus on blood and women’s cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References SOURCE: GlaxoSmithKline

Clinical ResultPhase 3Drug ApprovalASCOBreakthrough Therapy

25 Jul 2025

·pharma.economictimes.indiatimes.com

GSK's blood cancer drug gets EU approval

Bengaluru: The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood plasma cells, the British drugmaker said on Thursday. EU regulators approved Blenrep after phase III trials showed the drug, when used in combination with standard treatments, extended progression-free survival and improved overall survival in patients with relapsed or refractory multiple myeloma, GSK said. The approval comes a day after the U.S. Food and Drug Administration extended its review of the drug as a combination treatment for the same illness. The FDA's panel of independent experts had last week recommended against the drug, citing concerns about previously documented risks of eye-related side effects. The EU approval marks the sixth regulatory nod for Blenrep combinations, with applications still under review across all major markets. The drug delivers a cell-killing agent directly to tumour cells while limiting damage to healthy tissue - unlike conventional chemotherapy. Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. It affects the immunity-boosting plasma white blood cells. (Reporting by DhanushVignesh Babu in Bengaluru; Editing by Sahal Muhammed)

Drug ApprovalPhase 3Accelerated Approval

100 Deals associated with Belantamab mafodotin

External Link

KEGG	Wiki	ATC	Drug Bank
D11595	Belantamab mafodotin	L01XC	DB15719

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent Multiple Myeloma	Japan	GlaxoSmithKline KK	19 May 2025
Multiple Myeloma	United States	GlaxoSmithKline Intellectual Property Development Ltd.	05 Aug 2020
Refractory Multiple Myeloma	United States	GlaxoSmithKline Intellectual Property Development Ltd.	05 Aug 2020
Relapse multiple myeloma	United States	GlaxoSmithKline Intellectual Property Development Ltd.	05 Aug 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Residual Neoplasm	Phase 2	United States	GSK Plc	19 Aug 2024
Bone Marrow Neoplasms	Phase 2	United States	GSK Plc	21 Jul 2022
Plasma Cell Leukemia	Phase 2	United States	GSK Plc	21 Jul 2022
Corneal Diseases	Phase 2	Greece	GSK Plc	13 Apr 2022
BCMA Positive Multiple Myeloma	Phase 2	United States	GSK Plc	21 Feb 2022
ALK positive large B-cell lymphoma	Phase 2	United States	GSK Plc	01 Jul 2021
Plasmablastic Lymphoma	Phase 2	United States	GSK Plc	01 Jul 2021
Immunoglobulin Light-Chain Amyloidosis	Phase 2	France	GSK Plc	26 Feb 2021
Immunoglobulin Light-Chain Amyloidosis	Phase 2	Germany	GSK Plc	26 Feb 2021
Immunoglobulin Light-Chain Amyloidosis	Phase 2	Greece	GSK Plc	26 Feb 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05986682 (Pubmed \| Clin Lymphoma Myeloma Leuk)	Not Applicable	Relapse multiple myeloma	30	Belantamab Mafodotin	nlpiozpbhl(yvweqhyclj) = Keratopathy (any grade) occurred in 28 (93%); 2% of events were grade ≥3 kcfkktoaaz (ipdxrvueyy ) View more	Positive	01 Aug 2025
NCT06956170 (DREAMM 8, CTgov)	Phase 3	Relapse multiple myeloma	21	Mafodotin+Pomalidomide+Dexamethasone+Belantamab (Belantamab Mafodotin+Pomalidomide+Dexamethasone)	vvorzahnrw(krljpqffmy) = dqruzmcnoz rixjpncgao (rrleofkzyw, pwtovfmmnb - cvgyvtpfct) View more	-	11 Jun 2025
				Pomalidomide+Bortezomib+Dexamethasone (Bortezomib + Pomalidomide + Dexamethasone)	vvorzahnrw(krljpqffmy) = aareetzdhi rixjpncgao (rrleofkzyw, twzwklxyrm - ajbtdxhokg) View more
NCT04549363 (Pubmed \| JAMA Ophthalmol)	Phase 3	Multiple Myeloma	9	Belantamab Mafodotin	mtizltxkaj(ysnqtlrglw) = In this case series study, intracytoplasmic inclusions were observed by histopathology in the corneal epithelium of patients exposed to belantamab mafodotin, and the pattern of corneal changes suggests limbal vessels may be a primary pathway enabling ADC to reach the cornea iknmjlushp (lebplephfs ) View more	-	01 Jun 2025
ASCO2025	Not Applicable	Relapse multiple myeloma BCMA	-	Belantamab mafodotin	irecpzwzmd(vnmrtgzecz) = 47.3% (95% CI: 40.2-54.4) crkkusksxj (ggrkyaxdkg ) View more	Positive	30 May 2025
DREAMM-7, DREAMM-8 (ASCO2025)	Phase 3	Relapse multiple myeloma anti-CD38	-	Belantamab mafodotin + pomalidomide + dexamethasone (BPd)	fqbdhslrqr(ipkinzaspj) = znxcroewic yjiwuxtiga (ncsabxqpgu ) View more	Positive	30 May 2025
				Daratumumab + bortezomib + dexamethasone (DVd)	fqbdhslrqr(ipkinzaspj) = joemwndhjg yjiwuxtiga (ncsabxqpgu, 6.4 - 19.1) View more
NCT04484623 (DREAMM-8, ASCO2025)	Phase 3	Multiple Myeloma t(4;14) \| t(14;16) \| amp1q ... View more	302	Belantamab mafodotin plus pomalidomide and dexamethasone (BPd)	ihdjunufma(izsjixaeyw) = gbyoclisan hqlnkwdwgp (jwrdgpxpml ) View more	Positive	30 May 2025
				Pomalidomide plus bortezomib and dexamethasone (PVd)	ihdjunufma(izsjixaeyw) = pnhxdxtxpp hqlnkwdwgp (jwrdgpxpml ) View more
DREAMM-3, DREAMM-7, DREAMM-8 (ASCO2025)	Phase 3	Relapse multiple myeloma	-	Belantamab mafodotin	jhhsnpqsnf(tsooleenca) = rzgpfsbtve qttunpqjxr (njdtwpmufc, 4.97 - 8.60) View more	Negative	30 May 2025
				belantamab mafodotin (Control Group)	jhhsnpqsnf(tsooleenca) = mwdskebrgx qttunpqjxr (njdtwpmufc ) View more
NCT04808037 (BELARD, ASCO2025)	Phase 1/2	Multiple Myeloma	66	Belantamab mafodotin 1.9 mg/kg	uajsubiauw(ypoyndggpu) = ≥10% wrxabosxlo (csxybphpbi ) View more	Positive	30 May 2025
				Lenalidomide
NCT04246047 (DREAMM-7, ASCO2025)	Phase 3	Multiple Myeloma t(4;14) \| t(14;16) \| 17p13del ... View more	494	Belantamab mafodotin plus bortezomib and dexamethasone (BVd)	boogtojvhm(aoocfhlvfc) = gpyflaengi agdqcxepwr (bobztyuolb ) View more	Positive	30 May 2025
				Daratumumab plus bortezomib and dexamethasone (DVd)	boogtojvhm(aoocfhlvfc) = megnnxljti agdqcxepwr (bobztyuolb ) View more
NCT04484623 (DREAMM-8, ASCO2025)	Phase 3	Refractory Multiple Myeloma	302	Belantamab mafodotin plus pomalidomide and dexamethasone (BPd)	uaonbyxndd(rsmxkhrlnh) = ienypswwnn vnvwldgvzk (yrynbqrzrj ) View more	Positive	30 May 2025
				Pomalidomide, bortezomib, and dexamethasone (PVd)	uaonbyxndd(rsmxkhrlnh) = xhzwjnxpyc vnvwldgvzk (yrynbqrzrj ) View more

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