London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency (EMA) adopted a pos­i­tive opinion rec­om­mending the ap­prov­al of be­lan­ta­mab mafo­dotin as mono­therapy for the treat­ment of mul­ti­ple myeloma in adult patients, who have re­ceived at least four prior ther­a­pies and whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent, and an anti-CD38 mono­clonal anti­body, and who have dem­onstrated dis­ease pro­gres­sion on the last ther­apy.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of Oncology R&D, GSK said: “Today’s pos­i­tive opinion from the CHMP is an im­por­tant step in helping patients suffer­ing from re­lapsed or re­frac­tory mul­ti­ple myeloma who cur­rently have lim­ited op­tions and poor out­comes. If approved, be­lan­ta­mab mafo­dotin will provide patients and physicians across much of Europe with a first-in-class anti-BCMA treat­ment op­tion that works dif­fer­en­tly from other avail­able ther­a­pies for this incurable dis­ease.”

Belantamab mafo­dotin was granted PRIME desig­na­tion in 2017 and the Conditional Marketing Autho­ri­sa­tion Appli­ca­tion (CMAA) was re­­viewed under EMA’s ac­cel­er­ated assess­ment pro­ce­dure, which is given if the CHMP de­ter­mines the treat­ment is of major interest from a pub­lic health per­spec­tive and rep­re­sents a thera­peutic inno­va­tion. The CHMP pos­i­tive opinion is one of the final steps be­fore mar­ket­ing authori­sa­tion is granted by the Euro­pean Com­mis­sion, which has the authority to approve med­i­cines for use through­out the Euro­pean Union. If approved, be­lan­ta­mab mafo­dotin will be mar­keted as BLEN­REP and will be the sec­ond major regu­la­tory mile­stone for GSK’s on­col­ogy port­folio this year.

The CMAA is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study in­clud­ing 13-month follow-up data. These data dem­onstrated that treat­ment with single-agent be­lan­ta­mab mafo­dotin, admin­istered as a 2.5 mg/kg dose every three weeks (Q3W), re­­sulted in an over­all re­sponse rate of 32%. Median duration of re­sponse was 11 months and median over­all sur­vival was 13.7 months.

The safety and tol­er­a­bil­ity profile were con­sis­tent with pre­vi­ously re­ported data on be­lan­ta­mab mafo­dotin. The most commonly re­ported grade 3 or higher ad­verse events (occurring in more than 10% of patients) in patients re­ceiv­ing the 2.5 mg/kg dose were keratopathy/microcyst-like epithelial changes (MECs) (46%), thrombo­cyto­penia (22%), anaemia (21%), lym­pho­cyte count de­creased (13%) and neu­tro­penia (11%).

Belantamab mafo­dotin is also under re­­view by the US Food and Drug Admin­istra­tion which granted a priority re­­view for the com­pany’s Biologics License Appli­ca­tion (BLA).

About DREAMM-2

DREAMM-2 is an open label study of be­lan­ta­mab mafo­dotin. Patients in the trial had actively pro­gress­ing mul­ti­ple myeloma that had worsened de­spite cur­rent stan­dard of care and were ran­domised to two arms to re­ceive either 2.5 mg/kg or 3.4 mg/kg be­lan­ta­mab mafo­dotin Q3W. Over­all, patients in DREAMM-2 had more ad­vanced dis­ease, poorer prog­nosis and per­for­mance status and also had a greater num­ber of prior lines of ther­apy in comparison with patients in DREAMM-1, the first time in human study of be­lan­ta­mab mafo­dotin.

About mul­ti­ple myeloma

Multiple myeloma is the third most common blood can­cer world­wide and is generally con­sidered treatable, but not curable.¹ Re­search into new ther­a­pies is needed as mul­ti­ple myeloma commonly be­comes re­frac­tory to avail­able treat­ments.²

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.

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 "Risk Factors" in the com­pany's Annual Report on Form 20-F for 2019 and any im­pacts of the COVID-19 pan­dem­ic.

References

1. Estimated num­ber of incident cases world­wide, both sexes, all ages. World Health Or­ga­ni­za­tion. https://gco.iarc.fr/ Published 2020. Accessed May 2020.
2. Nooka A, Kastritis E, Dimopoulos M, Lonial S. Treatment op­tions for re­lapsed and re­frac­tory mul­ti­ple myeloma. Blood. 2015;125(20):3085-3099. doi:10.1182/blood-2014-11-568923.

Source: GlaxoSmithKline.