London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced the US Food and Drug Admin­istra­tion (FDA) will convene a meeting of the Oncologic Drugs Advisory Com­mit­tee (ODAC) to re­view data sup­port­ing the com­pany’s Biologics License Appli­ca­tion (BLA) for be­lan­ta­mab mafo­dotin for the poten­tial treat­ment of 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. The ODAC will meet virtually on 14 July 2020.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of Oncology R&D, GSK said: “We be­lieve be­lan­ta­mab mafo­dotin and the re­­sults from the DREAMM clin­i­cal trial pro­gramme have sig­nif­i­cant poten­tial for patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have lim­ited treat­ment op­tions. We look for­ward to participating in the up­com­ing advisory com­mit­tee meeting and work­ing with the FDA to com­plete its re­view of the BLA.”

Belantamab mafo­dotin re­ceived Break­­through Therapy Desig­na­tion in 2017, and the BLA was granted Priority Review status by the FDA in Jan­u­ary 2020 based on data from the pivotal DREAMM-2 (DRiv­ing Excellence in Approaches to Multiple Myeloma) study. Six-month pri­mary re­­sults from the study were pub­lished in The Lancet Oncology and follow-up data were pre­sented at the 2020 American Society of Clinical Oncology annual meeting.

Belantamab mafo­dotin is a poten­tial first-in-class, humanised, anti-BCMA (antibody drug con­ju­gate against B-cell maturation an­ti­gen) being in­ves­ti­gated in a robust clin­i­cal trial pro­gramme for the treat­ment of mul­ti­ple myeloma.¹ BCMA is a cell-surface pro­tein that plays an im­por­tant role in the sur­vival of plasma cells and is universally ex­pressed in patients with mul­ti­ple myeloma.²

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.³

About mul­ti­ple myeloma

Multiple myeloma is the sec­ond most common blood can­cer in the US and is generally con­sidered treatable, but not curable.⁴ Re­search into new ther­a­pies is needed as mul­ti­ple myeloma commonly be­comes re­frac­tory to avail­able treat­ments.⁵

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 anti-body 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. NCI Drug Dictionary - Anti-BCMA Anti­body-Drug Conjugate GSK2857916. National Cancer In­sti­tute. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-bcma-antibody-drug-conjugate-gsk2857916. Accessed May 2020.
2. Trudel S, Lendvai N, Popat R, et al. Targeting B-cell maturation an­ti­gen with GSK2857916 anti­body–drug con­ju­gate in re­lapsed or re­frac­tory mul­ti­ple myeloma (BMA117159): a dose escalation and ex­pan­sion phase 1 trial. The Lancet Oncology. 2018;19(12):1641-1653. doi:10.1016/s1470-2045(18)30576-x.
3. Lonial S, Lee HC, Badros A, et al. Be­lan­ta­mab mafo­dotin for re­lapsed or re­frac­tory mul­ti­ple myeloma (DREAMM-2): a two-arm, ran­domised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.
4. 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.
5. 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.