Form 6-K GSK PLC For: Nov 22
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 November 2022
Commission
File Number 001-15170
GSK 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: 22 November 2022, London UK
GSK provides an update
on Blenrep (belantamab mafodotin-blmf) US marketing
authorisation
GSK plc (LSE/NYSE: GSK) today
announced it has
initiated the process for withdrawal
of the
US marketing authorisation for Blenrep (belantamab
mafodotin-blmf) following the request of the US Food and Drug
Administration (FDA). This
request was based on the previously
announced outcome
of the DREAMM-3 phase
III confirmatory trial, which did not meet the requirements of
the US FDA Accelerated Approval
regulations. Blenrep is
a monotherapy treatment
for adult patients with relapsed or refractory multiple myeloma
(RRMM) who have received at least four prior therapies, including
an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an
immunomodulatory agent.
As part of the Company's efforts to ensure
physicians and patients are supported during this important time,
patients already enrolled
in the Blenrep Risk
Evaluation and Mitigation Strategy (REMS) programme will
have the option to
enrol in a
compassionate use programme to
continue to access treatment. Further
information on enrolling patients into the compassionate use
programme will be provided directly to REMS-enrolled
prescribers. Patients currently being treated
with Blenrep should
consult their healthcare provider.
GSK continues to believe, based on the totality of data available
from the DREAMM (DRiving
Excellence in Approaches to Multiple Myeloma) development programme,
that the benefit-risk profile of belantamab mafodotin-blmf remains
favourable in this hard-to-treat RRMM patient population. Patients
responding to belantamab mafodotin-blmf experienced durable
clinical benefit, and safety remains consistent with the known
safety profile.
Sabine Luik, Chief Medical Officer, said, "We
respect the Agency's approach to the accelerated approval
regulations and associated process. Multiple myeloma is a
challenging disease, with
poor outcomes for patients whose disease has become resistant to
standard-of-care treatments. We will continue the DREAMM clinical
trial programme and work with the US FDA on a path forward for this
important treatment option for patients with multiple
myeloma."
Additional trials within the DREAMM clinical trial programme are
designed to determine the benefit of belantamab
mafodotin-blmf in
combination treatment with novel therapies and standard-of-care
treatments in earlier lines of therapy and dosing optimisation to
maintain efficacy while reducing corneal events. Data from the
DREAMM-7 and DREAMM-8 phase III trials are event-driven, and
results are anticipated in the first half of 2023. The results of
these trials will be shared with health authorities and inform
future regulatory pathways.
About DREAMM-3
The DREAMM-3 phase III trial is an open-label, randomised
head-to-head superiority trial evaluating the efficacy and safety
of single-agent belantamab mafodotin compared to pomalidomide
in combination with low-dose dexamethasone (PomDex)
in patients with RRMM. A
total of 325 participants
were randomised in a 2:1 ratio to receive either single-agent
belantamab mafodotin administered as a 2.5 mg/kg dose every three
weeks or PomDex. Pomalidomide was administered daily on days 1 to
21 of each 28-day cycle, with dexamethasone administered once
weekly (days 1, 8, 15, and 22 of each cycle). The primary endpoint
was PFS. Secondary endpoints include overall survival, safety, ORR,
duration of response and assessment of minimal residual
disease.
About DREAMM-7
DREAMM-7 is evaluating the safety and efficacy of belantamab
mafodotin in combination with bortezomib and dexamethasone versus
daratumumab in combination with bortezomib and
dexamethasone.
About DREAMM-8
DREAMM-8 is assessing the efficacy and safety of belantamab
mafodotin in combination with pomalidomide and dexamethasone
compared with that of a combination of pomalidomide, bortezomib and
dexamethasone in participants with relapsed/refractory multiple
myeloma.
About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US
and is generally considered treatable but not
curable.[1],[2] In
the US, more than 32,000 people are estimated to be diagnosed with
multiple myeloma this year, and nearly 13,000 people will die from
the disease.[3] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[4]
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 is 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.[5]
About Blenrep
Blenrep is
an antibody-drug conjugate comprising a humanised BCMA monoclonal
antibody conjugated to the cytotoxic agent auristatin F via a
non-cleavable linker. The drug linker technology is licensed from
Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT
Technology licensed from BioWa Inc., a member of the Kyowa Kirin
Group.
Refer to the BLENREP
Prescribing Information for
a full list of adverse events and the complete important safety
information in the US.
GSK in oncology
GSK is focused on maximising patient survival through
transformational medicines. GSK's pipeline is focused on
immuno-oncology, tumour cell targeting therapies 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,
and antibody-drug conjugates, either alone or in
combination.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at gsk.com/company.
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Media:
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Tim
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Madeleine
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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James
Dodwell
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+44 (0)
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Josh
Williams
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+44 (0)
7385 415719
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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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 in the Company's
Annual Report on Form 20-F for 2021, GSK's Q3 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[1]CA: A Cancer
Journal for Clinicians, Vol. 70, Issue 1, Han/Feb 2020
Pages 7-30.
[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] SEER
Cancer Facts & Figures 2019. Available at:
https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed October
2021.
[4] Nooka
AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and
refractory multiple myeloma. Blood.
2015;125(20).
[5] 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.
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.
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GSK plc
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(Registrant)
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Date: November
22, 2022
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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