|
|
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: 13 September 2024, London UK
Blenrep (belantamab
mafodotin) in combination receives Breakthrough Therapy Designation
in China for treatment of relapsed/refractory multiple
myeloma
●
Granted
based on results from phase III head-to-head DREAMM-7
trial
●
Designation
expedites development of investigational drugs with potential for
substantial improvement over available therapies
●
Novel therapies needed in
multiple myeloma as patients typically relapse or stop responding
to initial treatments[1]
GSK plc (LSE/NYSE: GSK) today
announced that the Center for Drug Evaluation (CDE) of the National
Medical Products Administration (NMPA) in China has granted
Breakthrough Therapy Designation (BTD) for Blenrep (belantamab mafodotin) combined with
bortezomib plus dexamethasone (BorDex) for the treatment of
relapsed or refractory multiple myeloma. NMPA BTD is intended to
expedite the development of therapies for serious and
life-threatening diseases for which there are no existing
treatments or where initial evidence has shown an improvement in
patient outcomes over available treatment options.[2]
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: “Breakthrough
Therapy Designation in China underscores the potential
for Blenrep to
redefine outcomes for patients with multiple myeloma at or after
their first relapse. We look forward to continuing to work with the
health authority in China and others worldwide to
bring Blenrep-based
combinations to patients as expeditiously as
possible.”
BTD was granted 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 improvements in
progression-free survival (PFS) for belantamab mafodotin combined
with BorDex compared to daratumumab plus BorDex in relapsed or
refractory multiple myeloma.
A positive overall survival (OS) trend was observed but was not
statistically significant at the time of interim analysis.
Follow-up for OS continues. Results also showed clinically
meaningful improvements across all other secondary efficacy
endpoints, including deeper and more durable responses compared to
the standard of care combinations. The safety and tolerability
profile of the belantamab mafodotin combination in the DREAMM-7
trial was broadly consistent with the known profiles of the
individual agents.
Multiple myeloma is a growing health concern in China with
approximately 30,000 new cases each year[3].
The incidence in China has doubled and mortality has increased
1.5-fold in the past three decades.[4] This
underscores the need for novel, efficacious treatment options for
patients in China, particularly those with progressing disease that
has become resistant to the current standard of
care.
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] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[8]
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 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[9] 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, 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.
|
GSK enquiries
|
|
|
|
|
Media:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Dan
Smith
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
|
Lyndsay
Meyer
|
+1 202
302 4595
|
(Washington
DC)
|
|
|
|
|
|
|
Investor
Relations:
|
Nick
Stone
|
+44 (0)
7717 618834
|
(London)
|
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
|
|
|
Josh
Williams
|
+44 (0)
7385 415719
|
(London)
|
|
|
Camilla
Campbell
|
+44 (0)
7803 050238
|
(London)
|
|
|
Steph
Mountifield
|
+44 (0)
7796 707505
|
(London)
|
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
|
Frannie
DeFranco
|
+1 215
751 4855
|
(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 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] Moreau
P., Kumar S, San Miguel J, et al. Treatment of relapsed and
refractory multiple myeloma: recommendations from the International
Myeloma Working Group. The Lancet Oncology, Volume 22, Issue 3,
e105-e118.doi:10.1016/S1470-2045(20)30756-7.
[2] China
Drug Registration Regulation. Available at:
http://www.gov.cn/gongbao/content/2020/content_5512563.htm.
Accessed 12 September 2024.
[3] 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.
[4] 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.
[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):676Ð681.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 12 September 2024.
[8] 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.
[9] 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/.
Accessed 12 September 2024.
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.
|
|
GSK plc
|
|
|
(Registrant)
|
|
|
|
|
Date: September
13, 2024
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GSK plc
|