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GSK Announces European Medicines Agency (EMA) Accepted Marketing Authorisation Application For Belantamab Mafodotin For The Treatment Of Relapsed Or Refractory Multiple Myeloma

Published: Feb 3, 2020 4:00 am
  • 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

GSK Announces European Medicines Agency (EMA) Accepted Marketing Authorisation Application For Belantamab Mafodotin For The Treatment Of Relapsed Or Refractory Multiple Myeloma London, United Kingom (Press Release) – 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/
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 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-
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

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.

Cautionary state­ment re­gard­ing for­ward-looking state­ments

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.

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.

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