GSK announces European Medicines Agency (EMA) accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma
- Belantamab mafodotin accepted for accelerated assessment by the EMA's Committee for Human Medicinal Products (CHMP)
- Submission based on data from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) recently published in The Lancet Oncology
LONDON, Feb. 3, 2020 /PRNewswire/ -- GlaxoSmithKline plc today announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Belantamab mafodotin was accepted for accelerated assessment by the EMA's Committee for Human Medicinal Products (CHMP).
Accelerated assessment is granted if the CHMP determines the treatment is of major interest from a public health perspective and represents a therapeutic innovation. Validation of the MAA confirms that the submission is accepted and begins the formal review process by the CHMP.
The MAA is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study. Full results from the study, recently published in The Lancet Oncology, demonstrated a 31% overall response rate (ORR) with a 2.5 mg/kg regimen of single-agent belantamab mafodotin in heavily pre-treated patients with multiple myeloma who were refractory to an immunomodulatory drug and a proteasome inhibitor and were refractory and/or intolerant to an anti-CD38 antibody. The safety and tolerability profile was consistent with previously reported data on belantamab mafodotin.(i)
More than 48,000 people in the European Union were diagnosed with multiple myeloma in 2018.(ii) Belantamab mafodotin was granted PRIME designation in 2017 by the EMA, a programme that is intended to facilitate development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.
About multiple myeloma
Multiple myeloma is the second most common blood cancer and is generally considered treatable, but not curable.(iii) Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.(iv)
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.(v)
About the DREAMM clinical trial programme for belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational immunoconjugate 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
Planned 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/
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
NCT04126200
---
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
Planned 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-
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
Sponsored Study
---
GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
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GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.
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References
(i) Lonial, S, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020; 21(2):207-21.
(ii) World Health Organization: International Agency for Research on Cancer (IACR). Estimated number of incident cases from 2018 to 2040, multiple myeloma, both sexes, all ages, Europe. Available at: http://gco.iarc.fr/. Accessed December 18, 2019.
(iii) Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j.seminoncol.2016.11.004.
(iv) Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015;125(20)
(v) Carpenter RO, Evbuomwan MO et al. B-cell maturation antigen is a promising target for adoptive T-cell therapy of multiple myeloma. Clin Cancer Res. 2013 Apr 15;19(8):2048-60.
SOURCE GlaxoSmithKline plc
