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 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: 25 November 2024, London UK
Blenrep combinations
accepted for review by the US FDA for the treatment of
relapsed/refractory multiple myeloma
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Regulatory
submission supported by phase III head-to-head DREAMM-7 and
DREAMM-8 trials showing statistically significant efficacy,
including overall survival in DREAMM-7
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If
approved, Blenrep (belantamab
mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could
redefine multiple myeloma treatment at or after first
relapse
●
Sixth
major regulatory filing acceptance this year for belantamab
mafodotin combinations in this indication
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US
decision expected by 23 July 2025
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug
Administration (FDA) has accepted for review a Biologics License
Application (BLA) for Blenrep (belantamab mafodotin) in combinations with
bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus
dexamethasone (PomDex [BPd]) for the treatment of patients with
multiple myeloma who have received at least one prior line of
therapy. The US FDA has assigned a Prescription Drug User Fee Act
action date of 23 July 2025.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said:
"Relapsed/refractory multiple myeloma treatment could be
transformed by additional, efficacious treatment options with
manageable side effects and community-based administration. The
evidence from DREAMM-7 and DREAMM-8 supporting
our Blenrep combinations submission has been further
strengthened by the statistically significant overall survival
results from the DREAMM-7 trial. We look forward to working with
the FDA on this review."
The US application is based on results from the DREAMM-7 and
DREAMM-8 phase III trials, which both met their primary endpoints,
showing statistically significant and clinically meaningful
improvements in progression-free survival (PFS) for the belantamab
mafodotin combinations compared to standard of care triplet
combinations in relapsed or refractory multiple
myeloma.
Results from both trials also showed clinically meaningful
improvements across all other secondary efficacy endpoints,
including deeper and more durable responses compared to the
respective standard of care combinations. The safety and
tolerability profiles of the belantamab mafodotin combinations in
the DREAMM-7 and DREAMM-8 trials were broadly consistent with the
known profiles of the individual agents.
In a subsequent planned interim analysis, the DREAMM-7 trial also
met the key secondary endpoint of overall
survival[1] (OS),
showing a statistically significant and clinically meaningful OS
benefit favouring the belantamab mafodotin combination. Efficacy
and safety data from this analysis will be presented at the
upcoming 66th American Society of Hematology (ASH) Annual Meeting
and Exposition on 9 December 2024 at 11:15 a.m. PT. A positive
trend in OS was observed in DREAMM-8 but was not statistically
significant at the time of interim analysis, and follow-up for OS
continues.
This is the sixth major regulatory filing acceptance this year for
belantamab mafodotin combinations in 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 European
Union
[2], Japan[3] (with
priority review), United Kingdom, Canada and Switzerland (with
priority review for DREAMM-8). In China[4],
the National Medical Products Administration has granted
Breakthrough Therapy Designation for belantamab mafodotin in
combination with bortezomib and dexamethasone, as well as priority
review for the regulatory application based on the results of
DREAMM-7.
About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and
is generally considered treatable but not
curable.[5],[6] There
are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year.[7] Multiple
myeloma is a significant and enduring health concern in the US,
where more than 35,000 cases are expected to be diagnosed in
2024.6,[8] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[9]
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[10] 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 DREAMM-8
The DREAMM-8 phase III clinical trial is a multicentre, open-label,
randomised trial evaluating the efficacy and safety of belantamab
mafodotin in combination with pomalidomide
plus dexamethasone (BPd) compared to a combination of
bortezomib and pomalidomide plus dexamethasone (PVd) in
patients with relapsed/refractory multiple myeloma previously
treated with at least one prior line of multiple myeloma therapy,
including a lenalidomide-containing regimen, and who have
documented disease progression during or after their most recent
therapy. Compared to the patient population studied in the DREAMM-7
trial, patients in DREAMM-8 were more heavily pre-treated in that
all had prior exposure to lenalidomide, 78% were refractory to
lenalidomide, 25% had prior daratumumab exposure and of those most
were daratumumab refractory.
A total of 302 participants were randomised at a 1:1 ratio to
receive either BPd or PVd.
The primary endpoint is PFS as per an independent review committee.
The key secondary endpoints include OS and MRD negativity rate as
assessed by next-generation sequencing. Other secondary endpoints
include ORR, DOR, safety, and patient reported and quality of life
outcomes.
Results from DREAMM-8 were first presented[11] 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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Lyndsay
Meyer
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(Washington
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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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(London)
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Mick
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(London)
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Camilla
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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
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(Philadelphia)
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Frannie
DeFranco
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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
GSK's Q3 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[1] GSK
press release issued 14 November 2024. Blenrep shows overall
survival benefit in head-to-head DREAMM-7 phase III trial for
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-shows-overall-survival-benefit-in-head-to-head-dreamm-7-phase-iii-trial-for-relapsedrefractory-multiple-myeloma/.
[2] 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/.
[3] 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/.
[4] 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/.
[5] 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.
[6] 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.
[7] 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 5 July 2024.
[8] American
Cancer Society Cancer Statistics Center. Myeloma.
https://cancerstatisticscenter.cancer.org/#!/cancer-site/Myeloma.
Accessed April 2024.
[9] Nooka
AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and
refractory multiple myeloma. Blood.
2015;125(20).
[10] 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/.
[11] GSK
press release issued 02 June 2024. Blenrep combination reduced the
risk of disease progression or death by nearly 50% versus standard
of care combination in relapsed/refractory multiple myeloma
Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-combination-reduced-the-risk-of-disease-progression/.
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
25, 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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