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 September 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:
17 September 2024, London UK
Blenrep (belantamab
mafodotin) combinations in relapsed/refractory multiple myeloma
accepted for regulatory review in Japan
· Regulatory
submission supported by phase III head-to-head DREAMM-7 and
DREAMM-8 trials
· If
approved, Blenrep plus BorDex or PomDex
could redefine relapsed/refractory multiple myeloma treatment
landscape
· More
than 7,200 new cases of multiple myeloma are diagnosed in Japan
each year[1]
GSK plc
(LSE/NYSE: GSK) today announced that Japan's Ministry of Health,
Labour and Welfare (MHLW) has accepted for review a new drug
application (NDA) for Blenrep (belantamab mafodotin) in
combination with bortezomib plus dexamethasone (BorDex) or
pomalidomide plus dexamethasone (PomDex) as a treatment for
relapsed or refractory multiple myeloma. MHLW also has granted
orphan drug designation for Blenrep, which reflects the high unmet
medical need and ensures priority NDA review in multiple
myeloma.
This is
the third major regulatory filing acceptance for belantamab
mafodotin combinations in the treatment of relapsed/refractory
multiple myeloma, following marketing authorisation application
acceptance
[2] by
the European Medicines Agency (EMA) in July 2024 and by the
Medicines and Healthcare products Regulatory Agency (MHRA) in the
UK earlier this month.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "Blenrep combinations show
potential based on the results of the DREAMM-7 and DREAMM-8 trials
to redefine the treatment of relapsed/refractory multiple myeloma.
We are committed to working with health authorities worldwide to
advance Blenrep along regulatory pathways
so we can bring these additional treatment options to patients as
quickly as possible."
Multiple
myeloma presents a growing health concern in Japan, where the
number of patients diagnosed with multiple myeloma per year has
increased continuously over the last five decades.[3],[4] This
underscores the urgent need for more treatment options for patients
in Japan, particularly those with progressing disease that has
become resistant to the current standard of care.
The
application is based on interim 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 combinations in
relapsed or refractory multiple myeloma. A positive overall
survival (OS) trend was observed in both trials but was not
statistically significant at the time of interim analysis.
Follow-up for OS continues. The DREAMM-7 trial is evaluating
belantamab mafodotin combined with BorDex versus daratumumab plus
BorDex, while the DREAMM-8 trial is evaluating belantamab mafodotin
in combination with PomDex versus bortezomib plus
PomDex.
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 DREAMM-7 and DREAMM-8 trials
were broadly consistent with the known profiles of the individual
agents.
About multiple myeloma
Multiple
myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable.1,[5] There
are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year.[6] More
than 7,200 new cases of multiple myeloma are diagnosed in Japan
each year.1 Research into
new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[7]
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 BorDex compared to a combination of
daratumumab and BorDex 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, including Japanese patients, were randomised
at a 1:1 ratio to receive either belantamab mafodotin in
combination with BorDex or a combination of daratumumab and BorDex.
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[8] 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.
A Japan
expansion cohort is set to further evaluate the DREAMM-7 protocol
in Japanese patients. Results for Japanese participants will be
presented at a future scientific meeting.
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 PomDex compared to a combination of
bortezomib and PomDex 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, 75% were refractory
to lenalidomide, 25% had prior daratumumab exposure and of those
most were daratumumab refractory.
A total
of 302 participants, including Japanese patients, were randomised
at a 1:1 ratio to receive either belantamab mafodotin plus PomDex,
or bortezomib plus PomDex.
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[9] at
the 2024 ASCO Annual Meeting and published in the New England Journal of
Medicine.
A Japan
expansion cohort is set to further evaluate the DREAMM-8 protocol
in Japanese patients. Results for Japanese participants will be
presented at a future scientific meeting.
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, Israel
and Singapore. 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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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 Q2 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79 New
Oxford Street
London
WC1A
1DG
[1] National Cancer Registry (Ministry of Health,
Labour and Welfare), tabulated by Cancer Information Service,
National Cancer Center, Japan. Available here:
https://ganjoho.jp/reg_stat/statistics/data/dl/en.html. Accessed 12
September 2024.
[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] Ozaki S, Handa H, Saitoh T, et al. Trends of
survival in patients with multiple myeloma in Japan: a multicenter
retrospective collaborative study of the Japanese Society of
Myeloma. Blood Cancer J. 2015 Sep 18;5(9):e349.
[4] Handa H, Ishida T, Ozaki S et al. Treatment pattern
and clinical outcomes in multiple myeloma patients in Japan using
the Medical Data Vision claims database. PLoS One. 2023 Apr
6;18(4):e0283931.
[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] 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.
[7] Nooka AK, Kastritis E, Dimopoulos MA. Treatment
options for relapsed and refractory multiple myeloma. Blood.
2015;125(20).
[8] 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/
[9] 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: September
17, 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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