On June 4, 2020 GlaxoSmithKline (GSK) plc reported new data from its DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme of belantamab mafodotin in relapsed/refractory multiple myeloma will be presented at the upcoming virtual edition of the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress from 11-21 June 2020 (Press release, GlaxoSmithKline, JUN 4, 2020, View Source [SID1234560827]).
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Sixteen presentations in total will be shared at the meeting, including new analyses from the pivotal DREAMM-2 study evaluating belantamab mafodotin in heavily pre-treated patients with relapsed/refractory multiple myeloma. Key presentations include:
DREAMM-1 and DREAMM-2 Pooled Data: Safety and Tolerability of Single-agent Belantamab Mafodotin in Heavily Pre-Treated Patients With Relapsed/Refractory Multiple Myeloma (ePoster #EP948; Trudel S)
DREAMM-2: Assessing Efficacy Via Indirect Comparison of Single-agent Belantamab Mafodotin Versus Selinexor Plus Dexamethasone Combination in Anti-CD38 Exposed Relapsed/Refractory Multiple Myeloma (ePoster #EP1016; Popat R)
DREAMM-4: Evaluating Safety and Clinical Activity of Belantamab Mafodotin in Combination With Pembrolizumab in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (ePoster #EP955; Trudel S)
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "In today’s challenging environment we are committed to helping address the COVID-19 pandemic, while also progressing our scientific research to deliver innovative treatments for patients with cancer. We are proud to present data at EHA (Free EHA Whitepaper) from our extensive DREAMM clinical trial programme as we continue to advance belantamab mafodotin in various relapsed/refractory multiple myeloma treatment settings."
Belantamab mafodotin is an investigational humanised, anti-BCMA (antibody-drug conjugate against B-cell maturation antigen).[1] BCMA is a cell-surface protein that plays an important role in the survival of plasma cells and is universally expressed in patients with multiple myeloma.[2] A Biologics License Application (BLA) and Marketing Authorisation Application (MAA), are currently under review by the US Food and Drug Administration and European Medicines Agency, respectively. Data from the DREAMM-2 study of single-agent belantamab mafodotin in patients with RRMM who had received a median of seven prior lines of treatment and whose disease was progressing despite treatment with an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody, serve as the basis for the BLA and MAA.
Additional GSK presentations can be found below.
Belantamab mafodotin
Abstract Name
Presenter
Presentation Details
DREAMM-2 Pivotal Study: Analysis of the Lyophilized Presentation Cohort of Single-Agent Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma
Richardson P
ePoster #EP1048
DREAMM-2: Single-Agent Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma RRMM–Outcomes by Prior Therapies
Lonial S
ePoster #EP937
DREAMM-2: Belantamab Mafodotin Effect on Disease Symptoms and Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
Popat R
ePoster #EP1746
DREAMM-1: Patient Perspectives From the First-in-Human Study of Single-Agent Belantamab Mafodotin for Relapsed and Refractory Multiple Myeloma (RRMM)
Eliason L
Abstract #PB2064
DREAMM-2: Single-Agent Belantamab Mafodotin in Relapsed/Refractory Multiple Myeloma Refractory to PIs, Immunomodulatory Agents, and Refractory and/or Intolerant to Anti-CD38 mAbs
Lonial S
ePoster #EP970
DREAMM-2: Single-Agent Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) and High-Risk (HR) Cytogenetics
Trudel S
ePoster #EP1037
DREAMM-2: Single-agent Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) and Renal Impairment
Lee H
ePoster #EP1006
DREAMM-3: A Phase III, Open-label, Randomized Study of Single-Agent Belantamab Mafodotin Versus Pom/Dex in Relapsed/Refractory Multiple Myeloma (RRMM)
Weisel K
Abstract #PB2041
DREAMM-5 Platform Trial: Belantamab Mafodotin in Combination With Novel Agents in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
Richardson P
Abstract #PB2065
DREAMM-6: Safety and Tolerability of Belantamab Mafodotin in Combination with Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM)
Popat R
ePoster #EP1031
DREAMM-9: Phase III Study of Belantamab Mafodotin Plus VRd vs. VRd Alone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)
Usmani S
Abstract #PB2038
Relapsed/Refractory Multiple Myeloma
Abstract Name
Presenter
Presentation Details
Characteristics, Treatment Patterns, and Outcomes Among Patients with Relapsed/Refractory Multiple Myeloma in Europe
Casey V
ePoster #EP971
Estimating the Number of US Patients with Multiple Myeloma at Different Lines of Therapy
Nikolaou A
ePoster #EP963
About multiple myeloma
Multiple myeloma is the third most common blood cancer and is generally considered treatable, but not curable.[3] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[4]
About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B-cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[2]
About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational antibody-drug conjugate comprising a humanised anti-B-cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.
Belantamab mafodotin is not currently approved for use anywhere in the world.
Trial Name
GSK ID/NCT ID
Status
Design
DREAMM-1
117159/ NCT02064387
Completed
A Phase I Open-label Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA
DREAMM-2
205678/ NCT03525678
Active, not recruiting
A Phase II Study to Investigate the Efficacy and Safety of Two Doses of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma Who are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed Prior Treatment with an Anti-CD38 Antibody
DREAMM-3
207495/ NCT04162210
Recruiting
A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma
DREAMM-4
205207/ NCT03848845
Recruiting
A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma
DREAMM-5
208887/
NCT04126200
Recruiting
A Phase I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin (GSK2857916) with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma
DREAMM-6
207497/ NCT03544281
Recruiting
A Phase I/II Randomized Study to Evaluate Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Lenalidomide plus Dexamethasone (Arm A), or in Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects with Relapsed/Refractory Multiple Myeloma
DREAMM-7
207503/
NCT04246047
Recruiting
A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Dexamethasone versus Daratumumab, Bortezomib, and Dexamethasone in Participants with Relapsed/Refractory Multiple Myeloma
DREAMM-8
207499
Planned
A Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma
DREAMM-9
209664/ NCT04091126
Recruiting
A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Lenalidomide and Low-Dose Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for Transplant
DREAMM-10
207500
Planned
A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with a Novel Agent versus SoC
ISS/GSK Co-Sponsored Study
209418/ NCT03715478
Recruiting
A Phase I/II Dose-escalation and Dose-expansion Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pomalidomide plus Low-dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received Two or More Prior Lines of Therapy That Must Have Included Lenalidomide and a Proteasome Inhibitor