UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
 
 
 
For the month of July 2020
 
Commission File Number 001-15170
 
 
GlaxoSmithKline plc
(Translation of registrant's name into English)
 
 
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address of principal executive office)
 
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F . . . .X. . . . Form 40-F . . . . . . . .
 
 
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
 
 
 
 
Issued: 14 July 2020, London UK - LSE Announcement
 
GSK announces FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma
 
●      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
 
 
GlaxoSmithKline plc (LSE/NYSE: GSK) 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.[i] 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.[ii] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[iii]
 
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.iii 
 
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/.
 
 
GSK enquiries:
 
 
 
UK Media enquiries:
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+44 (0) 20 8047 5502
(London)
 
Tim Foley
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US Media enquiries:
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(Philadelphia)
 
Kathleen Quinn
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Analyst/Investor enquiries:
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Danielle Smith
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Jeff McLaughlin
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Frannie DeFranco
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(Philadelphia)
 
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.
 
 
Registered in England & Wales: 
No. 3888792
 
Registered Office: 
980 Great West Road 
Brentford, Middlesex
TW8 9GS

 
 
[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] 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.
[iii] 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.
 
 
 
 
 
SIGNATURES
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorised.
 
GlaxoSmithKline plc
 
(Registrant)
 
 
Date: July 15, 2020
 
 
 
 
By:/s/ VICTORIA WHYTE
--------------------------
 
 
 
Victoria Whyte
 
Authorised Signatory for and on
 
behalf of GlaxoSmithKline plc
 
 
 
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