• 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, 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.

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.