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 April 2026
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: 20 April 2026, London UK
Blenrep (belantamab
mafodotin) approved in China for treatment of 2L+
relapsed/refractory multiple myeloma
●
Blenrep combination
showed a 42% reduction in risk of death and nearly tripled median
progression-free survival versus a daratumumab-based
triplet[1],[2]
●
As
the only anti-BCMA approved in 2L+ multiple myeloma in
China, Blenrep provides
a new and needed mechanism of action in therapy1,[3]
●
Blenrep is
the only fully outpatient anti-BCMA therapy, minimising patient and
healthcare burden[4]
GSK plc (LSE/NYSE: GSK) today announced the National Medical
Products Administration (NMPA) of China has
approved Blenrep (belantamab mafodotin) in combination with
bortezomib and dexamethasone (BVd) for the treatment of adults with
relapsed or refractory multiple myeloma who have received at least
one prior line of therapy. The approval follows priority
review[5] of
the application and Breakthrough
Therapy Designation[6] for
the BVd combination based on its potential to provide substantial
improvement over available therapies.[7]
The Blenrep approval
is supported by data from the pivotal DREAMM-7 phase III trial.
These include statistically significant and clinically meaningful
progression-free survival (PFS) and overall survival (OS) results
for the Blenrep combination versus a daratumumab-based
triplet combination with bortezomib and dexamethasone
(DVd). The
safety and tolerability profiles of the Blenrep combination were broadly consistent with the
known profiles of the individual agents.1,2
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "Patients
with multiple myeloma who face relapse need treatment options that
are both effective and accessible. Today's approval
of Blenrep brings anti-BCMA therapy to patients in
China with relapsed or refractory multiple myeloma in 2L+,
introducing a differentiated mechanism of action with the potential
to help slow disease progression and extend survival.
Further, Blenrep as the only anti-BCMA ADC is fully
outpatient administered, so patients can be treated at any site of
care without complex pre-administration regimens or
hospitalisation."
In China, the incidence of multiple myeloma has doubled to
approximately 30,000 new cases annually and mortality has increased
by 50% over the past three decades.[8] Blenrep is
the only anti-BCMA (B-cell maturation antigen) antibody-drug
conjugate (ADC) approved in multiple myeloma, which provides
patients with a differentiated mechanism of
action. Blenrep can be administered to a range of patient
types across treatment settings as a 30-minute outpatient
infusion.
About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and
is generally considered treatable but not
curable.[9],[10] There
are approximately 180,000 new cases of multiple myeloma diagnosed
globally each year.[11] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.3 Many
patients with multiple myeloma are treated in a community cancer
setting, leaving an urgent need for new, effective therapies with
manageable side effects that can be administered outside of an
academic centre.[12],[13]
About Blenrep
Blenrep is a monoclonal
ADC comprising a humanised BCMA conjugated to the cytotoxic agent
monomethyl 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 in the US[14] in
combination with bortezomib plus dexamethasone for the treatment of
adults who have previously received at least two prior lines of
therapy, including a proteasome inhibitor and an immunomodulatory
agent. Blenrep has received more than 15 regulatory
approvals in 2L+ relapsed or refractory multiple myeloma in
combination with bortezomib and dexamethasone and in combination
with pomalidomide and dexamethasone, including in
the European
Union[15], UK[16], Japan[17],
Canada, Switzerland, Brazil and Australia. Applications are under
review in other countries globally.
The EU Prescribing Information is available here.[18]
The US Prescribing Information is available here.4
About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III
clinical trial evaluating the efficacy and safety of BVd compared
to DVd in patients with relapsed or 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. The trial enrolled 494
participants who were randomised 1:1 to receive either BVd or DVd.
Belantamab mafodotin was administered at a dose of 2.5mg/kg
intravenously every three weeks in combination for the first eight
cycles and then continued as a single agent. The primary endpoint
was PFS as per an independent review committee, with secondary
endpoints including 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.
In DREAMM-7 overall, BVd nearly tripled median PFS versus DVd (36.6
months versus 13.4 months, respectively (hazard ratio [HR]: 0.41
[95% confidence interval (CI): 0.31-0.53], p-value<0.00001).
DREAMM-7 also met the key secondary endpoint of OS, showing a
statistically significant and clinically meaningful 42% reduction
in the risk of death at a median follow-up of 39.4 months favouring
BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79;
p=0.00023). The three-year OS rate was 74% in the BVd arm and 60%
in the DVd arm.2
In DREAMM-7, BVd consistently benefited a broad range of patients,
including those with poor prognostic features or outcomes, such as
high-risk cytogenetics or those refractory to
lenalidomide. The
trial also showed clinically meaningful improvements across all
other secondary efficacy endpoints, including deeper and more
durable responses versus the comparator.2
DREAMM-7 showed that eye-related side effects associated
with Blenrep can
be managed and reversed with appropriate dose modifications and
follow-up. This allowed patients to maintain benefit and resulted
in low rates of discontinuation due to eye-related side effects
(≤9%). The most commonly reported non-ocular adverse
events (>30% of participants) in the Blenrep combination
arm were thrombocytopenia (87%) and diarrhoea (32%) in
DREAMM-7.2
PFS results[19] were
presented at the American Society of Clinical Oncology (ASCO)
Plenary Series in February 2024 and published in
the New England Journal of
Medicine. OS
results[20] were
presented at the American Society of Hematology (ASH) Annual
Meeting in December 2024.
GSK in oncology
Our ambition in oncology is to help increase overall quality of
life, maximise survival and change the course of disease, expanding
from our current focus on blood and women's cancers into lung and
gastrointestinal cancers, as well as other solid tumours. This
includes accelerating priority programmes such as antibody-drug
conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly
selective KIT tyrosine kinase inhibitor.
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 www.gsk.com.
|
GSK enquiries
|
|
|
|
|
Media:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Madison
Goring
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
|
Alison
Hunt
|
+1 540 742 3391
|
(Washington
DC)
|
|
|
|
|
|
|
Investor
Relations:
|
Constantin
Fest
|
+44 (0)
7831 826525
|
(London)
|
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
|
|
|
Steph
Mountifield
|
+44 (0)
7796 707505
|
(London)
|
|
|
Sam
Piper
|
+44 (0)
7824 525779
|
(London)
|
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
|
Frannie
DeFranco
|
+1 215
751 3126
|
(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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for
2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[1] Hungria
V, Robak P, Hus M et al. Belantamab Mafodotin, Bortezomib, and
Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug
1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1.
PMID: 38828933.
[2] Hungria
V, Robak P, H Marek, et al. Belantamab Mafodotin, Bortezomib, and
Dexamethasone Vs Daratumumab, Bortezomib, and Dexamethasone in
Relapsed/Refractory Multiple Myeloma: Overall Survival Analysis and
Updated Efficacy Outcomes of the Phase 3 Dreamm-7 Trial. Presented
at the 66th American Society of Hematology (ASH) Annual Meeting and
Exposition. December 2024.
[3] 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.
[4] Blenrep
US Prescribing Information.
[5] GSK
press release issued 9 December 2024. Blenrep (belantamab
mafodotin) combination accepted for priority review in China in
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/.
[6] 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/.
[7] China
Drug Registration Regulation. Available at:
http://www.gov.cn/gongbao/content/2020/content_5512563.htm.
Accessed 16 March 2026.
[8] 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.
[9] 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.
[10] 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.
[11] 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 March 2025.
[12] Gajra
A, Zalenski A, Sannareddy A, et al. Barriers
to Chimeric Antigen Receptor T-Cell (CAR-T) Therapies in Clinical
Practice. Pharmaceut
Med. 2022 Jun;36(3):163-171.
[13] Crombie
J, Graff T, Falchi L, et al. Consensus
recommendations on the management of toxicity associated with
CD3×CD20 bispecific antibody therapy. Blood (2024)
143 (16): 1565-1575.
[14] GSK
press release issued 23 October 2025. Blenrep approved by US FDA
for use in treatment of relapsed/refractory multiple myeloma.
Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-approved-by-us-fda-for-use-in-treatment-of-relapsedrefractory-multiple-myeloma/.
[15] GSK
press release issued 24 July 2025. Blenrep (belantamab mafodotin)
combinations approved in EU for treatment of relapsed/refractory
multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/.
[16] GSK
press release issued 17 April 2025. Blenrep (belantamab mafodotin)
combinations approved by UK MHRA in relapsed/refractory multiple
myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/.
[17] GSK
press release issued 19 May 2025. Blenrep (belantamab mafodotin)
combinations approved in Japan for treatment of relapsed/refractory
multiple myeloma. Available at
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/.
[18] European
Medicines Agency. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep. Accessed
16 March 2026.
[19] 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/.
[20] GSK
press release issued 09 December 2024. Blenrep shows significant
overall survival benefit, reducing the risk of death by 42% in
multiple myeloma at or after first relapse. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-shows-significant-overall-survival-benefit-reducing-the-risk-of-death-by-42-in-multiple-myeloma-at-or-after-first-relapse/.
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: April
20, 2026
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GSK plc
|
