a0849c
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 February 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: 5 February 2024, London UK
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
● 59%
reduction in risk of disease progression or death observed in
patients with Blenrep combination
versus standard of care daratumumab combination
● 36.6
months of median progression-free survival observed
with Blenrep combination
versus 13.4 months in daratumumab combination
● Strong,
clinically meaningful trend in overall survival
favouring Blenrep combination
was observed with 43% reduction in risk of
death
GSK plc (LSE/NYSE: GSK) today announced results from an interim
analysis of the DREAMM-7 phase III head-to-head trial
evaluating Blenrep (belantamab mafodotin) combined with
bortezomib plus dexamethasone (BorDex) versus daratumumab plus
BorDex in second-line and later treatment of relapsed or refractory
multiple myeloma. These data will be presented at the American
Society of Clinical Oncology (ASCO) Plenary Series on 6 February
2024.
In the primary endpoint of progression-free survival (PFS), a
statistically significant and clinically meaningful improvement was
observed with the belantamab mafodotin combination (n=243), showing
a 59% reduction in the risk of disease progression or death (hazard
ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53],
p-value<0.00001) compared to the daratumumab combination
(n=251). With a median follow-up of 28.2 months, the median PFS was
36.6 months (95% CI: 28.4-not reached [NR]) with the belantamab
mafodotin combination compared to 13.4 months (11.1-17.5) in the
daratumumab combination. The PFS effect was observed across all
prespecified subgroups, including those who were refractory to
lenalidomide and those with high-risk
cytogenetics. The
safety and tolerability profile of the
belantamab mafodotin combination was consistent with the known
profile of the individual agents.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "The
substantial progression-free survival benefit and strong overall
survival trend compared to a daratumumab standard of care
combination reinforce our belief in the potential for belantamab
mafodotin used in combination to redefine the treatment of multiple
myeloma at or after first relapse. We plan on sharing these results
with health authorities worldwide."
The belantamab mafodotin combination also resulted in clinically
meaningful improvements in all secondary efficacy endpoints
including a doubling of complete response rate (stringent complete
response plus complete response), minimal residual disease (MRD)
negativity rate and median duration of response (DOR). A strong and
clinically meaningful overall survival (OS) trend was observed at
the interim analysis, with a 43% reduction in the risk of death
(HR: 0.57 [95% CI: 0.40-0.80], p-value=0.00049), which has not yet
reached the interim criteria for statistical significance of OS. OS
follow-up continues and further analyses are planned.
María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical
Trials Unit, Haematology Department and Professor of Medicine at
the University of Salamanca, Spain, and DREAMM-7 principal
investigator, said: "These
results from DREAMM-7 show how belantamab mafodotin in combination
with BorDex represents a significant improvement over the
daratumumab-based regimen in a second-line multiple myeloma
treatment setting. Anti-BCMA therapies are helping to improve
outcomes for patients with multiple myeloma, and having an
off-the-shelf option, like belantamab mafodotin, that can be
administered in a community oncology treatment centre where the
majority of patients are treated has the potential to transform the
way we treat myeloma at or after first
relapse."
Key secondary endpoint summaries are listed below.
Key Secondary Endpoints
|
Endpoint
|
belantamab mafodotin + BorDex
(n= 243)
|
daratumumab + BorDex
(n=251)
|
ORR (overall response rate) (95% CI)
|
82.7% (77.4-87.3)
|
71.3% (65.3-76.8)
|
sCR (stringent complete response)
|
14.0%
|
5.2%
|
CR (complete response)
|
20.6%
|
12.0%
|
Very good partial response
|
31.3%
|
29.1%
|
Partial response
|
16.9%
|
25.1%
|
MRD negativity rate* (95% CI)
|
24.7 (19.4, 30.6)
|
9.6 (6.2, 13.9)
|
P-value
|
p<0.00001#
|
Median DOR (95% CI)**
|
35.6 months (30.5-NR)
|
17.8 months (13.8-23.6)
|
Overall survival
|
HR (95% CI)
P-value ***
|
0.57 (0.40-0.80)p=0.00049***
|
* Measured in patients with a sCR or CR.
** An Intent-to-treat restricted mean DOR (RMDoR) analysis
comparing DOR between arms showed a statistically significant
benefit in favour of the belantamab mafodotin combination (p <
0.00001).
*** Has not yet reached criteria for statistical significance (p
≤ 0.00037) of OS at this interim. Follow-up for OS is
ongoing.
#Nominal
p-value
Grade 3 or higher non-ocular adverse events of clinical interest in
the belantamab mafodotin combination and daratumumab combination
arms, respectively, included thrombocytopenia (55% and 35%;
exposure-adjusted event rate: 40 and 29, per 100 person-years),
neutropenia (12% and 6%), pneumonia (12% and 4%; exposure-adjusted
event rate: 8 and 3, per 100 person-years), and anaemia (8% and
10%).
Eye-related side effects, a known risk of treatment with belantamab
mafodotin, were generally reversible, manageable with dose
modification, and led to low (9%) treatment
discontinuations. Grade
3 or higher ocular adverse events occurred in 34% of patients
receiving the belantamab mafodotin combination and primarily
included blurred vision (22%), dry eye (7%), eye irritation (5%),
and visual impairment (5%). Eighty-two patients (34%) with a
best corrected visual acuity (BCVA) score of 20/25 or better in at
least one eye at baseline had a worsening in both eyes to 20/50 or
worse. Almost all these patients' events (98%) had resolved at the
time of this analysis. The median time to resolution was 22
days.
Global health status quality of life (QOL) as measured by the
EORTC-QLQ-C30 indicated no difference in global QOL between
different treatment arms over time.
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.
This includes the ongoing phase III DREAMM-8 trial evaluating
belantamab mafodotin in combination with pomalidomide and
dexamethasone versus bortezomib in combination with pomalidomide
and dexamethasone. DREAMM-8 data are expected in the second half of
2024.
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 bortezomib
and dexamethasone (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, DOR, and MRD negativity
rate as assessed by next-generation sequencing.
About multiple myeloma
Multiple myeloma is the third most common blood
cancer globally and is generally considered treatable but not
curable.1,2 There
are approximately 176,000 new cases of multiple myeloma diagnosed
globally each year.3 Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.4
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 EMA
Reference
Information (https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep)
for a full list of adverse events and the complete important safety
information in the EU.
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 the company's Annual Report on Form 20-F for
2022, and Q4 Results for 2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1 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.
2 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.
3 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.
4 Nooka AK,
Kastritis E, Dimopoulos MA. Treatment options for relapsed and
refractory multiple myeloma. Blood.
2015;125(20).
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: February
06, 2024
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GSK plc
|