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 June 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(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: 2 June 2024, London UK
Blenrep combination
reduced the risk of disease progression or death by nearly 50%
versus standard of care combination in relapsed/refractory multiple
myeloma
●
DREAMM-8
phase III trial showed statistically significant and clinically
meaningful improvement in primary endpoint of progression-free
survival (PFS)
●
Median
PFS not yet reached at 21.8 months median follow-up versus 12.7
months in bortezomib combination
●
Second trial to show robust efficacy for
a Blenrep combination versus a standard of care in
second line and later relapsed/refractory multiple
myeloma
●
Results simultaneously published in
the New England Journal of
Medicine
GSK plc (LSE/NYSE: GSK) today announced positive results from an
interim analysis of the DREAMM-8 phase III head-to-head trial
evaluating Blenrep (belantamab mafodotin), in combination with
pomalidomide plus dexamethasone (PomDex), versus a standard of
care, bortezomib plus PomDex, as a second line and later treatment
for relapsed or refractory multiple myeloma. These late-breaking
data, being presented today at the 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting (31 May - 4 June) in
Chicago, IL, were featured in the official ASCO press programme and
simultaneously published in the New England Journal of
Medicine.
On the primary endpoint of progression-free survival (PFS), a
statistically significant and clinically meaningful improvement
(hazard ratio [HR]: 0.52 [95% confidence interval (CI): 0.37-0.73],
p-value<0.001) was observed with the belantamab mafodotin
combination (n=155) compared to the bortezomib combination (n=147).
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 belantamab
mafodotin combination compared to 12.7 months (95% CI: 9.1-18.5) in
the bortezomib combination. At the end of one year, 71% (95% CI:
63-78) of patients in the belantamab mafodotin combination group
compared to 51% (95% CI: 42-60) in the bortezomib combination group
were alive and had not progressed. A benefit for belantamab
mafodotin plus PomDex 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.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "With
the robust results from the DREAMM-8 phase III head-to-head trial,
we now have consistent data from two phase III trials supporting
the potential for Blenrep combinations
to redefine the treatment of multiple myeloma at or after first
relapse. This is exciting news given the high unmet need for new
and efficacious combinations once patients relapse or stop
responding to initial treatments. We continue to share data and
discuss our path forward with regulators."
A positive overall survival (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. At the end of one year, 83% (95% CI: 76-88) of
patients were alive in the belantamab mafodotin combination group
versus 76% (95% CI: 68-82) in the bortezomib combination group. The
safety and tolerability profile of the belantamab mafodotin
combination was broadly consistent with the known profile of the
individual agents.
Suzanne Trudel, MD, Department of Medical Oncology and Hematology,
Princess Margaret Cancer Centre, University Health Network,
Toronto, Canada, said: "The
profound progression-free survival benefit seen in DREAMM-8
highlights the potential for belantamab mafodotin, when used with
pomalidomide and dexamethasone, to improve outcomes for patients
with relapsed/refractory multiple myeloma. This combination may
have potential to redefine treatment of multiple myeloma at or
after first relapse, a setting where patients may benefit from
novel therapies."
Similar to the results seen in the DREAMM-7 phase III head-to-head
trial, in DREAMM-8 the belantamab mafodotin combination also
resulted in clinically meaningful improvements consistently across
secondary efficacy endpoints, showing that the belantamab mafodotin
combination resulted in deeper and more durable responses compared
to the bortezomib combination. Key improvements included rate of
complete response (CR) or better (more than twofold improvement);
minimal residual disease (MRD) negativity rate (nearly fivefold
improvement); and duration of response (median not yet reached with
the belantamab mafodotin combination versus 17.5 months with the
bortezomib combination).
Key and other secondary endpoint summaries are listed
below.
Key and Other Secondary Endpoints
|
Endpoint
|
belantamab mafodotin + pomalidomide and dexamethasone
(BPd)
(n= 155)
|
pomalidomide + bortezomib and dexamethasone (PVd)
(n=147)
|
ORR (overall response rate), % (95% CI)
|
77% (70.0-83.7)
|
72% (64.1-79.2)
|
sCR
(stringent complete response), %
|
9%
|
3%
|
CR
(complete response), %
|
31%
|
14%
|
VGPR
(very good partial response), %
|
24%
|
22%
|
PR
(partial response), %
|
14%
|
34%
|
CR or better rate (sCR+CR), % (95% CI)
|
40% (32.2-48.2)
|
16% (10.7-23.3)
|
VGPR or better rate (sCR+CR+VGPR), % (95%
CI)
|
64% (55.8-71.4)
|
38% (30.2-46.5)
|
MRD negativity rate* % (95% CI)
|
23.9% (17.4-31.4)
|
4.8% (1.9-9.6)
|
Duration of response (months), median (95% CI)
|
NR (24.9-NR)
|
17.5 months (12.1-26.4)
|
Overall Survival**
|
HR (95% CI)
|
0.77 (0.53-1.14)
|
* Measured in patients with a sCR or CR.
** Follow-up for OS is ongoing.
NR: Not yet reached.
Grade 3 or higher non-ocular adverse events (AEs) of clinical
interest in the belantamab mafodotin combination versus bortezomib
combination arms, respectively, included neutropenia (57% versus
39%; 42 patients/100 person-years in both arms); thrombocytopenia
(38% versus 29%; 28 vs 31 patients/100 person-years); and pneumonia
(17% versus 8%; 13 versus 8 patients/100
person-years).
Eye-related side effects, a known risk of treatment with belantamab
mafodotin, were generally reversible, manageable with dose
modifications, and led to low (9%) treatment discontinuation
rates. Grade
3 or higher ocular adverse events occurred in 43% of patients
receiving the belantamab mafodotin combination (Grade 3: 42%; Grade
4: 1%). Most commonly reported grade 3 or higher ocular symptoms
included blurred vision (Grade 3: 17%; Grade 4: 0), dry eye (Grade
3: 8%: Grade 4: 0), and foreign body sensation in the eyes (Grade
3: 6%; Grade 4: 0). Fifty-one patients (34%) with a best
corrected visual acuity (BCVA) of 20/25 or better in at least one
eye at baseline had a worsening in both eyes to 20/50 or worse. At
the time of this analysis, the first occurrence of such events had
improved in 92% of these patients, and resolved in 85%, with a
median time to resolution of 57 days (range: 14-451
days).
Global health status quality of life (QOL), as measured by the
EORTC-QLQ-C30 remained stable in both treatment arms over time,
suggesting that treatment did not lead to any decline in overall
health related QOL.
The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma)
clinical development programme continues to evaluate the potential
of belantamab mafodotin in early lines of treatment and in
combination with novel therapies and standard of care treatments.
DREAMM-8 is the second phase III head-to-head belantamab mafodotin
combination trial in second line and later treatment for multiple
myeloma to report positive results. Positive findings from
DREAMM-7, a phase III head-to-head trial evaluating belantamab
mafodotin in combination with bortezomib and dexamethasone (BorDex)
versus daratumumab plus BorDex in the same treatment setting,
were presented1 at
the ASCO Plenary Series on 6 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 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 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. Key secondary endpoints
include OS, minimal residual disease negativity as assessed by
next-generation sequencing, and duration of response. Other
secondary endpoints include ORR, patient-reported quality of life
outcomes, adverse events, eye exam findings, and laboratory
investigations.
About multiple myeloma
Multiple myeloma is the third most common blood
cancer globally and is generally considered treatable but not
curable.2,3 There
are approximately 176,000 new cases of multiple myeloma diagnosed
globally each year.4 Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.5
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.
Refer to the Blenrep UK Summary
of Product Characteristics6 for
a full list of adverse events and the complete important safety
information in the United Kingdom.
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)
|
|
Madison Goring
|
+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)
|
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 Q1 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1 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/.
2 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.
3
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.
4
Multiple Myeloma: Statistics. Cancer.net. Published February 2022.
https://www.cancer.net/cancer-types/multiple-myeloma/statistics#:~:text=This%20year%2C%20an%20estimated%2034%2C470,with%20multiple%20myeloma%20in%202020.
Accessed 19 October 2023.
5
Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for
relapsed and refractory multiple myeloma. Blood.
2015;125(20).
6 Blenrep UK Summary of Product Characteristics,
available at:
https://mhraproducts4853.blob.core.windows.net/docs/6f7040d4dd63fafa1f228164fce767517be4e3c6.
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: June
03, 2024
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GSK plc
|
GSK (PK) (USOTC:GLAXF)
Historical Stock Chart
From Jun 2024 to Jul 2024
GSK (PK) (USOTC:GLAXF)
Historical Stock Chart
From Jul 2023 to Jul 2024