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 July 2025
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: 23 July 2025,
London UK
GSK announces extension of US Food and
Drug Administration review period for Blenrep (belantamab mafodotin-blmf) in
relapsed/refractory multiple myeloma
●
New PDUFA date
scheduled for 23 October
2025
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug
Administration (FDA) has extended the review period for the
Biologics License Application (BLA) for Blenrep combinations[1] for
the treatment of patients with relapsed or refractory multiple
myeloma who have received at least one prior line of therapy. The
new Prescription Drug User Fee Act (PDUFA) action date is 23
October 2025 and provides the FDA with time to review additional
information provided in support of the
application.
The BLA is supported by efficacy results shown
by Blenrep combinations in the pivotal DREAMM-7 and
DREAMM-8 phase III trials in relapsed or refractory multiple
myeloma. These include statistically significant and clinically
meaningful progression-free survival results
for Blenrep combinations versus triplet standard of care
combinations in both trials and overall survival versus a
daratumumab-based triplet in DREAMM-7. The safety and tolerability
profiles of the Blenrep combinations were broadly consistent with
the known profiles of the individual agents.
GSK is confident in the data supporting Blenrep combinations and looks forward to ongoing
constructive conversations with the FDA as they continue their
review.
Blenrep combinations
are currently approved in the UK[2], Japan[3],
Canada, Switzerland (DREAMM-8 only at this time) and the United
Arab Emirates. Applications are currently under review in all major
markets globally, including the EU[4] and China[5] (based
on the results of DREAMM-7, with Breakthrough Therapy Designation
for the combination and priority review for the
application).
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] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[9] 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.[10],[11]
About Blenrep
Blenrep is an ADC
comprising a humanised BCMA 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.
Indication
Blenrep combinations
were approved in relapsed or refractory multiple myeloma in the UK
in April 2025.
In the UK, Blenrep is indicated in adults for the treatment of
multiple myeloma:
● in combination with bortezomib and dexamethasone
in patients who have received at least one prior therapy;
and
● in combination with pomalidomide and dexamethasone
in patients who have received at least one prior therapy including
lenalidomide.
IMPORTANT SAFETY INFORMATION
FOR BLENREP
More information can be found in the Blenrep Summary
of Product Characteristics and Patient Information leaflets
available on the MHRA Products website.[12]
About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III
clinical trial evaluating the efficacy and safety of belantamab
mafodotin combined with bortezomib plus dexamethasone (BVd)
compared to daratumumab combined with bortezomib plus dexamethasone
(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 2.5 mg/kg
intravenously every three weeks in
combination for the first eight cycles and then continued as a
single agent. The
primary endpoint was progression-free survival (PFS) as per an
independent review committee, with secondary endpoints including
overall survival (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, 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.
PFS results 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 were
presented at the American Society of Hematology (ASH) Annual
Meeting in December 2024.[13],[14]
About DREAMM-8
DREAMM-8 is
a multicentre, open-label, randomised phase III clinical trial
evaluating the efficacy and safety of belantamab
mafodotin in
combination with pomalidomide plus dexamethasone (BPd) compared to
bortezomib and pomalidomide plus dexamethasone (PVd) in patients
with relapsed or 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. The trial
included 302 participants who were randomised 1:1 to receive
either BPd or
PVd. 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. Belantamab
mafodotin was administered at a dose of 2.5 mg/kg intravenously for
the first cycle and then 1.9 mg/kg intravenously every four weeks.
The primary endpoint was PFS as per an independent review
committee, with key secondary endpoints including 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.
At the primary analysis at a median follow-up of 21.8 months, the
median PFS was not yet reached (95% CI: 20.6-not yet reached [NR])
with the Blenrep combination compared to 12.7 months in the
bortezomib combination (95% CI: 9.1-18.5). A positive OS trend was
observed but not statistically significant (HR: 0.77 [95% CI:
0.53-1.14]) at the interim analysis. OS follow-up continues and
further analyses are planned.
With additional follow-up, a clinically meaningful benefit
continued to be observed, with a near-tripling of the median PFS
for the Blenrep combination versus the bortezomib
combination (32.6 months versus 12.5 months, respectively (HR: 0.49
[95% CI: 0.35-0.68]). At the end of one year, 71% (95% CI: 63-78)
of patients in the BPd combination group compared to 51% (95% CI:
42-60) in the PVd combination group were alive and had not
progressed. A benefit for BPd was observed across all pre-specified
subgroups including those with poor prognostic features, such as
patients who were refractory to lenalidomide and patients with
high-risk cytogenetics.
Results were first presented at the 2024 ASCO Annual Meeting
and published in the New England Journal of
Medicine.[15] Updated
PFS results were presented at European Hematology Association
Congress (EHA) 2025.[16]
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 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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[1]Belantamab
mafodotin in combination with bortezomib plus dexamethasone (BVd)
and belantamab mafodotin in combination with pomalidomide plus
dexamethasone (BPd).
[2] 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/.
[3] 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/.
[4] GSK
press release issued 23 May 2025. Blenrep (belantamab mafodotin)
combinations receive positive CHMP opinion in relapsed/refractory
multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-receive-positive-chmp-opinion-in-relapsedrefractory-multiple-myeloma/.
[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] 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 5 March 2025.
[9] 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.
[10] 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.
[11] 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.
[12] Medicines
& Healthcare products Regulatory Agency website:
https://products.mhra.gov.uk/.
[13] 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.
[14] 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.
[15] Dimopoulos
MA, Beksac M, Pour L, Delimpasi S et al. Belantamab
Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N
Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407.
Epub 2024 Jun 2. PMID: 38828951.
[16] Dimopoulos
MA, Beksac M, Pour L et al. Updated results from phase 3 DREAMM-8
study of Belantamab Mafodotin, Pomalidomide and Dexamethasone
versus Pomalidomide plus Bortezomib and Dexamethasone in
relapsed/refractory multiple myeloma. HemaSphere | 2025;9(S1) 846
EHA 2025 Congress.
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: July
23, 2025
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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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