RegulationPriority Review (US), Accelerated Approval (US), PRIME (EU), Priority Review (CN), Breakthrough Therapy (CN), Breakthrough Therapy (US), Orphan Drug (US)

Gene Sequence

Sequence Code 33466H

Source: *****

Sequence Code 33489L

Source: *****

Clinical Trials associated with Belantamab mafodotin

NCT06679101 / Not yet recruitingPhase 3

A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.

Start Date28 Nov 2024

Sponsor / Collaborator

GSK Plc

NCT06232044 / Not yet recruitingPhase 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 Date30 Aug 2024

Sponsor / Collaborator

Alliance for Clinical Trials in Oncology

[+1]

NCT04876248 / RecruitingPhase 2IIT

Phase 2 Trial of Belantamab Mafodotin Consolidation Treatment in Patients With Multiple Myeloma and MRD Positivity After Autologous Stem Cell Transplantation

This phase II trial investigates the effect of belantamab mafodotin and lenalidomide on minimal residual disease negative rates in patients with multiple myeloma with minimal residual disease positive after stem cell transplant. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell maturation antigen (BCMA) receptors, and delivers mafodotin to kill them. Lenalidomide may help block the formation of growths that may become cancer, and is used as a standard of care treatment for multiple myeloma. Giving belantamab mafodotin and lenalidomide may help to maintain minimal residual disease negativity in patients with multiple myeloma.

Start Date19 Aug 2024

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Belantamab mafodotin

100 Translational Medicine associated with Belantamab mafodotin

100 Patents (Medical) associated with Belantamab mafodotin

180

Literatures (Medical) associated with Belantamab mafodotin

14 Oct 2024·LEUKEMIA & LYMPHOMA

Phase 1 first-in-human study of MEDI2228, a BCMA-targeted ADC, in patients with relapsed refractory multiple myeloma

Article

Author: Ailawadhi, Sikander ; Jiang, Yu ; Dimopoulos, Meletios A. ; Larsen, Jeremy ; Brown, Miranda ; Yee, Andrew J. ; Kinneer, Krista ; Kumar, Shaji ; Williams, Marna ; Pore, Nabendu ; Cheng, Lily I. ; Walcott, Farzana L. ; Migkou, Magdalini ; Bhutani, Manisha ; Kagiampakis, Ioannis ; Sirdesai, Shreerang ; Wang, Fujun ; Kalff, Anna ; Zonder, Jeffrey A. ; Kubiak, Robert J. ; Wu, Yuling

MEDI2228 is an antibody drug conjugate (ADC) comprised of a fully human B-cell maturation antigen (BCMA) antibody conjugated to a pyrrolobenzodiazepine (PBD) dimer. This phase 1 trial evaluated MEDI2228 in patients with relapsed/refractory (R/R) multiple myeloma (MM), who received prior treatment with approved agents from 3 classes of antimyeloma drugs (proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies). Primary endpoint was safety and tolerability; secondary endpoints included efficacy, pharmacokinetics, and immunogenicity. A total of 107 patients were treated and the maximum tolerated dose (MTD) was 0.14 mg/kg Q3W. Two patients had dose-limiting toxicities (DLTs; thrombocytopenia; 0.20 mg/kg Q3W). The most frequent treatment-related adverse events were photophobia (43.9%), rash (29.0%), and thrombocytopenia (19.6%). In MTD cohort A (n = 41), the objective response rate (ORR) was 56.1%, with 1 stringent complete response, 9 very good partial responses, and 13 partial responses. ORR was 53.3% in triple refractory patients. In cohort B (n=25), ORR was 32%. Although MEDI2228 demonstrated efficacy in R/R MM, ocular toxicity precluded further development of this drug.

10 Oct 2024·NEW ENGLAND JOURNAL OF MEDICINE

Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma

Letter

Author: Krecak, Ivan ; Lucijanic, Marko ; Sabljic, Anica

02 Oct 2024·CURRENT MEDICAL RESEARCH AND OPINION

Matching-adjusted indirect comparison of talquetamab vs selinexor-dexamethasone and vs belantamab mafodotin in patients with relapsed/refractory multiple myeloma

Article

Author: Reece, Donna ; Heuck, Christoph ; Londhe, Anil ; Diels, Joris ; Pei, Lixia ; Van Sanden, Suzy ; Chari, Ajai ; Kane, Colleen ; Ammann, Eric ; Peterson, Steve

OBJECTIVE:

Talquetamab is the first GPRC5D-targeting bispecific antibody approved for the treatment of triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM). This matching-adjusted indirect comparison (MAIC) study was conducted to compare the effectiveness of talquetamab vs selinexor-dexamethasone (sel-dex) and vs belantamab mafodotin (belamaf) in patients with TCE RRMM.

METHODS:

An unanchored MAIC was performed using individual patient-level data from patients treated with subcutaneous talquetamab 0.4 mg/kg weekly (QW) and 0.8 mg/kg every other week (Q2W) from MonumenTAL-1 (NCT03399799/NCT04636552) and published summary data for sel-dex from STORM (NCT02336815) and belamaf from DREAMM-2 (NCT0325678). Patients from MonumenTAL-1 who met key eligibility criteria for STORM and DREAMM-2 were included. Outcomes of interest were overall response rate (ORR), complete response or better (≥CR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

RESULTS:

After adjustment for cross-trial differences, patients treated with both dosing schedules of talquetamab showed significantly better ORR, ≥CR, and DOR vs sel-dex and significantly higher ORR and ≥ CR vs belamaf; DOR was relatively similar to belamaf. PFS was significantly improved with talquetamab Q2W and numerically in favor of talquetamab QW vs sel-dex and significantly improved with both dosing schedules of talquetamab vs belamaf. OS was significantly improved with both dosing schedules of talquetamab vs sel-dex and was numerically in favor of both dosing schedules of talquetamab vs belamaf.

CONCLUSION:

These analyses show superior effectiveness of both talquetamab dosing schedules vs sel-dex and vs belamaf for most outcomes and highlight talquetamab as an effective treatment option for patients with TCE RRMM.

News (Medical) associated with Belantamab mafodotin

10 Dec 2024

·pipelinereview.com

Belantamab Mafodotinshows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse

PHILADELPHIA, PA, USA I December 09, 2024 I GSK plc (LSE/NYSE: GSK) today announced statistically significant and clinically meaningful overall survival (OS) results from a planned interim analysis of the DREAMM-7 trial evaluating belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) versus daratumumab in combination with bortezomib plus dexamethasone (DVd) as a second line or later treatment for relapsed or refractory multiple myeloma. These data were featured today in an oral presentation at the 66 th American Society of Hematology (ASH) Annual Meeting and Exposition. The OS findings from DREAMM-7 build on previous data from the DREAMM-7 1 and DREAMM-8 2 trials, which showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for both belantamab mafodotin-based combinations versus standard of care comparators. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The compelling overall survival data from the DREAMM-7 trial establish the potential of belantamab mafodotin in combination to significantly extend the lives of patients with multiple myeloma at or after first relapse. This represents an important advancement that could redefine the treatment of relapsed or refractory multiple myeloma.” With a median follow up of 39.4 months, the analysis presented today shows a statistically significant 42% reduction in the risk of death among patients receiving the belantamab mafodotin combination (n=243) versus the daratumumab-based comparator (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). Although the median overall survival (mOS) was not reached in either arm of the study, the projected mOS for BVd is 84 months compared to 51 months for DVd. 3 The three-year OS rate was 74% in the belantamab mafodotin combination arm and 60% in the daratumumab combination arm. The survival benefit favoring BVd was seen as early as four months and was sustained over time as illustrated by the separation of the lines in the Kaplan-Meier curve shown above. María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit, Hematology Department and Professor of Medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, said : “The totality of evidence from DREAMM-7 represents a potential paradigm shift for multiple myeloma patients who have experienced a relapse or become refractory to initial treatment. The OS results shown with the belantamab mafodotin combination in DREAMM-7 further cement the potential of this regimen to prolong the lives of patients with relapsed or refractory multiple myeloma compared to a standard of care daratumumab combination.” The belantamab mafodotin combination also showed statistically significant superiority on the key secondary endpoint of minimal residual disease (MRD) negativity (no detectable cancer cells) compared to the daratumumab combination. The greater than 2.5-fold improvement in the rate of MRD negativity seen at the time of the primary analysis for patients who received BVd can now be declared as statistically significant (p<0.00001) after the positive OS readout based on the predefined testing procedure. This further underscores the transformative potential of this belantamab mafodotin combination for multiple myeloma patients at or after their first relapse. In addition to OS and MRD negativity, the belantamab mafodotin combination resulted in clinically meaningful improvements in all key secondary efficacy endpoints compared to the daratumumab combination, including duration of response (DOR) and progression-free survival 2 (PFS 2). The results indicate deeper and more durable responses among patients treated with BVd compared to DVd. The safety and tolerability of the belantamab mafodotin regimen were consistent with the primary analysis and known safety profile of the individual agents. Grade 3 or higher adverse events of clinical interest in the belantamab mafodotin combination and daratumumab combination arms, respectively included thrombocytopenia (56% versus 35%; 34 versus 25 patients/100 person-years); anemia (9% versus 10%; exposure-adjusted rate [per 100 person-years] not reported); and neutropenia (14% versus 10%; 8 versus 7 patients/100 person-years). Eye-related side effects, a known risk of treatment with belantamab mafodotin, were generally manageable and resolvable with dose modification, and led to a low (10%) treatment discontinuation rate. Full data summaries for OS and other key secondary endpoints are shown below. In 2024, regulatory filings for belantamab mafodotin combinations for the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials have been accepted in the US 4 , European Union 5 , Japan 6 (with priority review), China (for DREAMM-7 only, with priority review; Breakthrough Therapy Designation 7 also granted), United Kingdom, Canada and Switzerland (with priority review for DREAMM-8). About the DREAMM clinical development program The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development program continues to evaluate the potential of belantamab mafodotin in early lines of treatment and in combination with novel therapies and standard of care treatments. In addition to DREAMM-7 and DREAMM-8, a phase III study in newly diagnosed transplant ineligible multiple myeloma, DREAMM-10, is expected to be initiated by the end of 2024. About DREAMM-7 The DREAMM-7 phase III clinical trial is a multi-center, open-label, randomized trial evaluating the efficacy and safety of belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) compared to a combination of daratumumab and bortezomib plus dexamethasone (DVd) in patients with relapsed/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. A total of 494 participants were randomized at a 1:1 ratio to receive either BVd or DVd. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks. The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include 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. Results from DREAMM-7 were first presented 1 at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO Annual Meeting, and published in the New England Journal of Medicine . About multiple myeloma Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. 8,9 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. 10 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. 11 Many patients with multiple myeloma, including approximately 65% in the US, 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 center. 12,13,14 About belantamab mafodotin Belantamab mafodotin is an investigational antibody-drug conjugate comprising a humanized B-cell maturation antigen 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. GSK in oncology Oncology is an emerging therapeutic area for GSK where we are committed to maximizing patient survival with a current focus on hematologic malignancies, gynecologic cancers and other solid tumors through breakthroughs in immuno-oncology and tumor-cell targeting therapies. 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 us.gsk.com . SOURCE: GlaxoSmithKline

Clinical ResultPhase 3ASCOBreakthrough TherapyPriority Review

09 Dec 2024

·medcitynews.com

GSK Multiple Myeloma Drug’s DREAMM Comeback Continues With Phase 3 Data at ASH - MedCity News

A GSK multiple myeloma medicine that was pulled from the market after failing its confirmatory test has new data from a Phase 3 study evaluating it an earlier line of treatment, and the latest results show the drug is helping patients live longer compared to a standard drug regimen. Clinical trial investigators and the company believe these results could support making the GSK drug, Blenrep, a new standard of care treatment for this type of blood cancer. The new trial results for Blenrep were presented Monday during the annual meeting of the American Society of Hematology. The FDA is reviewing data from the drug’s full Phase 3 program, which tested the drug head to head against two standard of care multiple myeloma drug regimens. An FDA decision is expected in July; Blenrep is also under regulatory review in six additional markets. While many treatments are available for multiple myeloma, frequent relapse in this type of blood cancer means patients need new treatment options that take different approaches to the disease. Blenrep is an antibody drug conjugate (ADC) designed to target BCMA, a protein abundant on the surface of multiple myeloma cells. The drug is administered as an intravenous infusion every three weeks. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech The Blenrep results presented Monday are from a Phase 3 test, DREAMM-7, that enrolled nearly 500 patients whose multiple myeloma relapsed or was refractory to at least one earlier line of therapy. The open-label study evaluated Blenrep in combination with bortezomib, brand name Velcade, and the corticosteroid dexamethasone, a standard multiple myeloma drug regimen typically shortened to BorDex. Blenrep and BorDex were compared against the CD38-targeting Johnson & Johnson multiple myeloma drug daratumumab, brand name Darzalex, combined with BorDex. The main clinical trial goal was measuring progression-free survival. On this endpoint, results showed the study drug achieved a median 36.6 months of progression-free survival versus a median 13.4 months in the comparator arm. On the key secondary goal of duration of response, results showed 40.8 months for the Blenrep arm, more than double the duration of the comparator. On overall survival, the median has not yet been reached in either arm, according to the primary analysis. But with a median follow-up of 39.4 months, GSK projects median overall survival for the Blenrep arm will be 84 months compared to 51 months for the comparator drug regimen. Dr. María-Victoria Mateos, principal investigator for DREAMM-7 and head of myeloma and clinical trials unit, hematology department, and professor of medicine at the University of Salamanca, Spain, sees the new Blenrep results as potentially practice changing. If the drug reaches the market, it could become a new standard of care drug regimen for relapsed and refractory multiple myeloma after at least one prior line of therapy, she said, speaking during a Monday briefing with journalists. In the same briefing, Hesham Abdullah, GSK’s senior vice president, global head oncology, highlighted the near tripling of progression-free survival achieved by Blenrep versus the comparator regimen, along with a strong duration of response to the therapy. He also noted the important marks for overall survival benefit — how long patients live while receiving treatment. Blenrep led to a 42% reduction in the risk of death versus the comparator. Abdullah noted this survival benefit is in line with results from an interim analysis reported earlier this year. Exclusive Heard at HLTH 2024: Insights from Innovative Healthcare Executives Executives from Imagine360, Verily, BrightInsight, Lantern, and Rhapsody shared their approaches to reducing healthcare costs and facilitating digital transformation. By MedCity News Blenrep’s 2020 accelerated FDA approval covered the use of the drug as a fifth-line multiple myeloma therapy, making it the first approved BCMA-targeting therapy. But after the drug, tested as a monotherapy, failed to show statistically signficiant improvement on the main goal of progression-free survival in its confirmatory Phase 3 test, GSK in 2022 withdrew the product from the market. Abdullah said that despite failing the confirmatory trial, results showed Blenrep was an active drug that behaved similarly to two other drug multiple myeloma combination regimens. The company proceeded to test Blenrep again, but as an earlier line of therapy and in combination with existing multiple myeloma therapies. In addition to the DREAMM-7 Phase 3 test against the Darzalex/BorDex combination, the Blenrep regimen was tested separately against the Bristol Myers Squibb drug Pomalyst and dexamethasone. In this Phase 3 study, DREAMM-8, results presented this past June during the annual meeting of the American Society of Clinical Oncology showed the Blenrep regimen led to a 48% reduction in the risk of disease progression or death. The multiple myeloma market has become more crowded in Blenrep’s absence. There are now two FDA-approved cell therapies that target BCMA: Abecma from Bristol Myers Squibb and 2SeventyBio, and Carvykti from Johnson & Johnson and Legend Biotech. Both were initially approved as fifth-line treatments. Earlier this year, the FDA expanded the approvals of both products, permitting Abecma to be used as a third-line therapy and Carvytki as a second-line treatment. J&J’s multiple myeloma portfolio also includes Tecvayli, a BCMA-targeting bispecific antibody. Besides Carvykti, the other BCMA-targeting therapies are approved only for use as later-line therapies, Mateos said. In the second-line setting, not all multiple myeloma patients will be eligible for a CAR T-cell therapy. Also, Carvykti, made by harvesting and engineering a patient’s own immune cells, takes weeks to manufacture, she said. By contrast, Blenrep provides multiple myeloma patients a readily available off-the-shelf treatment option. Abdullah added that Blenrep offers more flexibility compared with CAR T-therapy, which is offered only in certain hospitals equipped to administer these therapies and manage their complications. “We know that the majority of multiple myeloma patients sit within the community setting and oftentimes don’t have access to these more specialized technologies that require hospitalization and carry a different risk/benefit profile,” Abdullah said. Blurred vision and vision loss are known complication risks of ADCs as a drug class. When Blenrep was initially approved, its label carried a black box warning for ocular toxicity. GSK said eye-related side effects were generally manageable in the clinical trial and resolved with dose modification. These complications led to a discontinuation rate of about 10% in DREAMM-7. GSK has broader plans for Blenrep, which the company estimates could achieve £3 billion (about $3.8 billion) in peak sales. By comparison, J&J’s Darzalex posted $8.5 billion in revenue in the first nine months of 2024, a 19.3% increase compared to the same period in the prior year. GSK believes Blenrep could take some of the J&J product’s market share by securing additional approval as a first-line multiple myeloma treatment. A Phase 1 test is ongoing in newly diagnosed patients to identify the dose and drug combination to evaluate in a pivotal study. As GSK explores moving Blenrep into frontline use, Abdullah said the company is focused on improving the overall profile of the drug — maintaining efficacy while enhancing tolerability. Mateos said based on the DREAMM-7 data, BCMA is the better target than the CD38 target hit by Darzalex. The next step is comparing the two drugs in a first-line setting. Positive results for Blenrep could potentially change the treatment landscape for multiple myeloma, she said. Photo by GSK

Phase 3Clinical ResultDrug ApprovalCell TherapyASCO

06 Dec 2024

·www.echemi.com

GSK Invests $1 Billion for Exclusive License of ADC Drug DB-1324

GlaxoSmithKline (GSK) has signed an exclusive licensing agreement with Eucure Biopharma, under which GSK acquires the rights to develop and commercialize the ADC drug DB-1324 globally, excluding mainland China, Hong Kong, and Macau. The total amount of the deal reaches an impressive $1.005 billion. DB-1324, an innovative ADC molecule developed based on Eucure Biopharma's DITAC platform, is currently in the preclinical stage and is expected to be used for treating gastrointestinal cancers. GSK will pay a $30 million upfront fee and up to $975 million in additional payments upon reaching specific milestones. Additionally, GSK will pay tiered royalties based on global net sales. This transaction is significant for GSK's strategic layout in the ADC field and further proves the international recognition of Chinese biopharmaceutical companies in ADC R&D. It is noteworthy that GSK’s other ADC drug, Blenrep, received breakthrough therapy designation and accelerated approval from the FDA but was withdrawn from the U.S. market in December 2022 due to disappointing clinical trial results. Despite setbacks in the U.S. market, GSK has not abandoned its efforts in other regions and is exploring new clinical trial data to hopefully re-enter the market. In June 2024, GSK announced the results of the DREAMM-7 and DREAMM-8 Phase III trials at the ASCO conference, showing that Blenrep combination therapy significantly extended patients' progression-free survival and reduced the risk of disease progression or death. These positive trial results prompted GSK to resubmit its application for Blenrep's market approval. In addition to Blenrep, GSK's ADC portfolio includes several other drugs. For instance, XMT-2056 is currently in clinical research, while HS-20089 and HS-20093, developed in collaboration with Hanmi Pharmaceutical, are also undergoing clinical trials. These collaborations and positive clinical trial results not only strengthen GSK's ADC product line in cancer treatment but also indicate a favorable position in market competition. Through these efforts, GSK aims to achieve greater breakthroughs in cancer treatment and provide patients with more treatment options.

Clinical ResultLicense out/inPhase 3Breakthrough TherapyADC

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
Multiple Myeloma	US	Glaxosmithkline Intellectual Property Development Ltd.	05 Aug 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	NDA/BLA	CN	GlaxoSmithKline Manufacturing SpA	07 Dec 2024
Relapse multiple myeloma	NDA/BLA	CN	GlaxoSmithKline Trading Services Ltd.	07 Dec 2024
Refractory Multiple Myeloma	Phase 3	US	GSK Plc	01 Oct 2020
Refractory Multiple Myeloma	Phase 3	CN	GSK Plc	01 Oct 2020
Refractory Multiple Myeloma	Phase 3	JP	GSK Plc	01 Oct 2020
Refractory Multiple Myeloma	Phase 3	AU	GSK Plc	01 Oct 2020
Refractory Multiple Myeloma	Phase 3	BR	GSK Plc	01 Oct 2020
Refractory Multiple Myeloma	Phase 3	CZ	GSK Plc	01 Oct 2020
Refractory Multiple Myeloma	Phase 3	FR	GSK Plc	01 Oct 2020
Refractory Multiple Myeloma	Phase 3	DE	GSK Plc	01 Oct 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04246047 (DREAMM-7, ASH2024) Manual	Phase 3	Multiple Myeloma	494	Belantamab mafodotin, bortezomib, and dexamethasone (BVd)	usdqnnxaiz(ncsxbqutty) = rsocarlifx hbvzktgqsm (vuqpcqyeyv, 28.4 - NR) Met View more	Positive	09 Dec 2024
				Daratumumab, bortezomib, and dexamethasone (DVd)	usdqnnxaiz(ncsxbqutty) = wdbyjnhjhw hbvzktgqsm (vuqpcqyeyv, 11.1 - 17.5) Met View more
NCT04246047 (DREAMM-7, ASH2024) Manual	Phase 3	Multiple Myeloma	494	Belantamab mafodotin plus Bortezomib and Dexamethasone (BVd)	vfvhhrrsjr(prmvggdcgj) = zdwvcuqyeq ophfctwxje (uyaabsycbi ) View more	Positive	08 Dec 2024
				Daratumumab, Bortezomib,Bortezomib, and DexamethasoneDexamethasone (DVd)	vfvhhrrsjr(prmvggdcgj) = inpiwyqaxo ophfctwxje (uyaabsycbi ) View more
SOHO2024	Not Applicable	Multiple Myeloma	-	Belantamab Mafodotin (Belamaf) + Bortezomib and Dexamethasone (BVd)	aqdxaaaueg(pjwjtbotit) = wfscflavnz clmnhaspns (ylvytztnps, 77.4 - 87.3) View more	-	04 Sep 2024
				Daratumumab, Bortezomib, and Dexamethasone (DVd)	aqdxaaaueg(pjwjtbotit) = hczaabgshl clmnhaspns (ylvytztnps, 65.3 - 76.8) View more
NCT04484623 (DREAMM-8, ASCO2024) Manual	Phase 3	Multiple Myeloma Second line	302	Belantamab mafodotin+pomalidomide+dexamethasone	mlqsunyrfs(fvnchiftxt) = xcytxxxsww xporykcdxu (nlecrypzfb, 20.6 - NR) View more	Positive	02 Jun 2024
				Pomalidomide+bortezomib+dexamethasone	mlqsunyrfs(fvnchiftxt) = qfndkacajc xporykcdxu (nlecrypzfb, 9.1 - 18.5) View more
NCT04484623 (DREAMM-8, Pubmed)	Phase 3	Multiple Myeloma lenalidomide-refractory disease	302	Belantamab mafodotin, pomalidomide, and dexamethasone (BPd)	yyzfyzuvfs(ejkoarhzud) = Ocular events were common but were controllable by belantamab mafodotin dose modification ggxzickkpv (iojvpivlbq ) View more	Positive	02 Jun 2024
				Pomalidomide, bortezomib, and dexamethasone (PVd)
NCT04246047 (DREAMM-7, ASCO2024) Manual	Phase 3	Multiple Myeloma high-risk cytogenetics	494	Belantamab mafodotin (Belamaf) + Bortezomib and Dexamethasone (BVd)	jwudkryliz(ngipzdties) = zjterckwdt wpkuwkliwx (vqywizegdj ) View more	Positive	24 May 2024
				Daratumumab, Bortezomib, and Dexamethasone (DVd)	jwudkryliz(ngipzdties) = ihxefspzaj wpkuwkliwx (vqywizegdj ) View more
NCT04617925 (EMN27, EHA2024) Manual	Phase 2	Immunoglobulin Light-Chain Amyloidosis	35	BELANTAMAB MAFODOTIN	xknzekxrwx(akbgtlvfab) = moevjeefyi tkhjrtkkeh (lfgnxsqbdc ) View more	Positive	14 May 2024
CMG012022 (EHA2024) Manual	Phase 2	Multiple Myeloma	24	Belantamab mafodotin 1.9 mg/kg Q8W + Bortezomib + Dexamethasone	lybpjdlknp(hljvdzgoew) = ewftsadadt vcxdwjtjqo (iftdemzosk ) View more	Positive	14 May 2024
NCT04808037 (BelaRd, EHA2024)	Phase 1/2	Multiple Myeloma	36	Belantamab mafodotin 1.9 mg/kg Q8W	(xnrmvokmru) = pmsdiczfbn qegzwigyvr (vipnjuxbrd ) View more	Positive	14 May 2024
				Lenalidomide and dexamethasone	(xnrmvokmru) = wkztujzxux qegzwigyvr (vipnjuxbrd ) View more
NCT04177823 (CTgov)	Phase 1	Relapse multiple myeloma \| Refractory Multiple Myeloma	6	Belantamab Mafodotin	uklihxnrtm(xjiegdozbn) = lxjouqihzo kraxfzgrbv (eskpxgqzyn, rmbbmjrajw - smpkvjudjc) View more	-	19 Apr 2024

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis