• Recommendation based on re­view of DREAMM clin­i­cal trial pro­gramme, in­clud­ing the pivotal DREAMM-2 study
• If approved, be­lan­ta­mab mafo­dotin will be a first-in-class anti-BCMA ther­apy for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma

London, United Kingdom (Press Release) – GlaxoSmithKline to­day an­nounced the US Food and Drug Admin­istra­tion (FDA) Oncologic Drugs Advisory Com­mit­tee (ODAC) voted 12-0 in favour of the dem­onstrated ben­e­fit of mono­therapy treat­ment with be­lan­ta­mab mafo­dotin outweighing the risks for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body. Two com­mit­tee members could not par­tic­i­pate in the final vote.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of Oncology R&D, GSK said: “We are pleased the com­mit­tee recognised the po­ten­tial for be­lan­ta­mab mafo­dotin to help patients who have re­lapsed or re­frac­tory mul­ti­ple myeloma, an incurable dis­ease with lim­ited treat­ment op­tions. We look for­ward to work­ing with the FDA as they com­plete their re­view of our Biologics License Appli­ca­tion.”

The recom­men­da­tion was based on data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clin­i­cal trial pro­gramme, in­clud­ing the pivotal DREAMM-2 study which en­rolled heavily pre-treated patients who had actively pro­gress­ing mul­ti­ple myeloma that had worsened de­spite cur­rent stan­dard of care.¹ The six-month pri­mary re­­sults from the study were pub­lished in The Lancet Oncology in De­cem­ber 2019 and serve as the basis for the Biologics License Appli­ca­tion (BLA).

The FDA will con­sider the recom­men­da­tion of the com­mit­tee but is not obligated to follow it. The FDA granted break­­through ther­apy desig­na­tion to be­lan­ta­mab mafo­dotin in 2017 and priority re­view desig­na­tion for the BLA earlier this year. A Marketing Autho­ri­sa­tion Appli­ca­tion for be­lan­ta­mab mafo­dotin also is under ac­cel­er­ated assess­ment by the Euro­pean Medicines Agency.

Belantamab mafo­dotin is not cur­rently approved for use any­where in the world.

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.

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 every three weeks. 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 sec­ond most common blood can­cer in the US and is generally con­sidered treatable, but not curable.² Re­search into new ther­a­pies is needed as mul­ti­ple myeloma commonly be­comes re­frac­tory to avail­able treat­ments.³

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.³

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. 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.
2. 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.
3. 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.