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 December 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(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 . . . . . . . .
Issued:
9 December 2024, London UK
Blenrep (belantamab mafodotin)
combination accepted for priority review in China in
relapsed/refractory multiple myeloma
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Regulatory
submission supported by phase III head-to-head DREAMM-7 trial
showing statistically significant efficacy, including overall
survival
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If
approved, Blenrep combination could redefine
multiple myeloma treatment at or after first relapse
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Seventh
major regulatory filing acceptance this year for belantamab
mafodotin combinations in this indication, following US filing
acceptance based on DREAMM-7 and DREAMM-8
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GSK plc (LSE/NYSE: GSK) today announced that the National Medical
Products Administration (NMPA) of China has accepted for review a
new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with
bortezomib plus dexamethasone (BVd) as a treatment for relapsed or
refractory multiple myeloma. Earlier this year, the NMPA granted
priority review for this application as well as Breakthrough
Therapy Designation[1] for
the BVd combination, which is intended to expedite development of
investigational drugs with potential for substantial improvement
over available therapies.
[2]
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "Today's
regulatory filing acceptance, with a priority review, is a
meaningful step forward in our efforts to bring the benefits
of Blenrep in combination to patients in China.
Multiple myeloma patients need new options that may improve
outcomes, particularly at first relapse. The DREAMM-7 trial shows statistically significant
efficacy, including overall survival and could redefine treatment
in this patient population."
This is the seventh major regulatory filing acceptance this year
for belantamab mafodotin in combination for the treatment of
relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8
trials. In 2024, belantamab mafodotin combinations have
been accepted for review in the US[3], European
Union[4], Japan[5] (with
priority review), United Kingdom, Canada and Switzerland (with
priority review for DREAMM-8).
The
application is based on the interim results of the phase III
head-to-head DREAMM-7 trial, which met its primary endpoint,
showing statistically significant and clinically meaningful
improvement in progression-free survival (PFS) for BVd compared to
daratumumab plus bortezomib and dexamethasone (DVd) in relapsed or
refractory multiple myeloma. In a subsequent planned interim
analysis, the DREAMM-7 trial met the key secondary endpoint of
overall survival (OS), showing that BVd significantly reduced the
risk of death versus standard of care DVd.
About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and
is generally considered treatable but not
curable.[6],[7] There
are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year.[8] In
China, multiple myeloma is a
growing health concern with approximately 30,000 new cases each
year.[9] The
incidence of multiple myeloma in China has doubled and mortality
has increased 1.5-fold in the past three
decades.[10] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[11]
About DREAMM-7
The DREAMM-7 phase III clinical trial is a multicentre, open-label,
randomised trial evaluating the efficacy and safety of belantamab
mafodotin in combination with bortezomib plus
dexamethasone (BVd) compared to a combination
of daratumumab and bortezomib plus
dexamethasone (DVd) in patients with
relapsed/refractory multiple myeloma who previously were treated
with at least one prior line of multiple myeloma therapy, with
documented disease progression during or after their most recent
therapy.
A total of 494 participants were randomised at a 1:1 ratio to
receive either BVd or DVd. Belantamab mafodotin was scheduled to be
dosed at 2.5mg/kg intravenously every three weeks.
The primary endpoint is PFS as per an independent review committee.
The key secondary endpoints include OS, duration of response (DOR),
and minimal residual disease (MRD) negativity rate as assessed by
next-generation sequencing. Other secondary endpoints include
overall response rate (ORR), safety, and patient reported and
quality of life outcomes.
Results from DREAMM-7 were first presented[12] at
the American Society of Clinical Oncology (ASCO) Plenary Series in
February 2024, shared in an encore presentation at the 2024 ASCO
Annual Meeting, and published in the New England
Journal of Medicine.
About Blenrep
Blenrep is an
antibody-drug conjugate comprising a humanised B-cell maturation
antigen 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.
Blenrep is approved as monotherapy in
Hong Kong. Refer to the local Summary of Product Characteristics
for a full list of adverse events and complete important safety
information.
GSK in oncology
Oncology
is an emerging therapeutic area for GSK where we are committed to
maximising patient survival with a current focus on haematologic
malignancies, gynaecologic cancers, and other solid tumours through
breakthroughs in immuno-oncology and tumour-cell targeting
therapies.
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.
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GSK enquiries
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Media:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Madison
Goring
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+44 (0)
20 8047 5502
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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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Annabel
Brownrigg-Gleeson
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+44 (0)
7901 101944
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(London)
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James
Dodwell
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+44 (0)
7881 269066
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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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Camilla
Campbell
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+44 (0)
7803 050238
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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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 under Item 3.D
"Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSKs Q3 Results for 2024.
Registered
in England & Wales:
No.
3888792
Registered
Office:
79 New
Oxford Street
London
WC1A
1DG
[1] GSK press release issued 13 September 2024.
Blenrep (belantamab mafodotin) in combination receives Breakthrough
Therapy Designation in China for treatment of relapsed/refractory
multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-in-combination-receives-breakthrough-therapy-designation-in-china-for-treatment-of-relapsedrefractory-multiple-myeloma/.
[2] China Drug Registration Regulation. Available at:
http://www.gov.cn/gongbao/content/2020/content_5512563.htm.
Accessed 1 October 2024.
[3] GSK press release issued 25 November 2024.
Blenrep combinations accepted for review by the US FDA for the
treatment of relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations-accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple-myeloma/.
[4] GSK press release issued 19 July 2024. Blenrep
(belantamab mafodotin) combinations in multiple myeloma accepted
for review by the European Medicines Agency. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-multiple-myeloma-application-accepted-for-review-by-the-european-medicines-agency/.
[5] GSK press release issued 17 September 2024.
Blenrep (belantamab mafodotin) combinations in relapsed/refractory
multiple myeloma accepted for regulatory review in Japan. Available
at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-relapsedrefractory-multiple-myeloma-accepted-for-regulatory-review-in-japan/.
[6] Sung H, Ferlay J, Siegel R, et al. Global Cancer
Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality
Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin.
2021;71(3):209-249. doi:10.3322/caac.21660.
[7] 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.
[8] Global Cancer Observatory. International Agency
for Research on Cancer. World Health Organization. Multiple Myeloma
fact sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf. Accessed
1 October 2024.
[9] Global Cancer Observatory. International Agency
for Research on Cancer. World Health Organization. China fact
sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf.
Accessed 12 September 2024.
[10] Liu J, Liu W, Mi L, et al. Burden of multiple myeloma in China: an analysis
of the Global Burden of Disease, Injuries, and Risk Factors Study
2019. Chin Med J (Engl). 2023;136(23):2834-2838. Published 2023 Dec
5. doi:10.1097/CM9.0000000000002600.
[11] Nooka AK, Kastritis E, Dimopoulos MA. Treatment
options for relapsed and refractory multiple myeloma. Blood.
2015;125(20). doi:10.1182/blood-2014-11-568923.
[12] GSK press release issued 05 February 2024.
DREAMM-7 phase III trial shows Blenrep combination nearly tripled
median progression-free survival versus standard of care
combination in patients with relapsed/refractory multiple myeloma.
Available at:
https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/.
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: December
09, 2024
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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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