GlaxoSmithKline : GSK announces FDA Advisory Committee meeting to review belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma

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Issued: London UK - LSE announcement

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.