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 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:
24 April 2024, London UK
US FDA accepts for priority review
GSK's application for an expanded indication
of Jemperli (dostarlimab) plus chemotherapy to include
all adult patients with primary advanced or recurrent endometrial
cancer
●
Application supported by
statistically significant and clinically meaningful
progression-free and overall survival data from phase III RUBY Part
1 trial
●
Dostarlimab plus chemotherapy is the
only immuno-oncology-based therapy to show a statistically
significant and clinically meaningful survival benefit in the
overall patient population
●
23 August 2024 assigned as
Prescription Drug User Fee Act action date for FDA
decision
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug
Administration (FDA) accepted the supplemental Biologics License
Application (sBLA) for Jemperli (dostarlimab) in combination with
standard-of-care chemotherapy (carboplatin and paclitaxel) to
expand treatment to all adult patients with primary advanced or
recurrent endometrial cancer. This would include patients with
mismatch repair proficient (MMRp)/microsatellite stable (MSS)
tumours.
Currently, Jemperli is FDA-approved in combination with
carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult
patients with primary advanced or recurrent endometrial cancer that
is either mismatch repair deficient (dMMR), as determined by an
FDA-approved test, or microsatellite instability-high
(MSI-H).
The FDA granted Priority Review for this application and assigned a
Prescription Drug User Fee Act action date of 23 August
2024.
The sBLA is based on results from Part 1 of the RUBY phase III
trial. The trial met its primary endpoints of investigator-assessed
progression-free survival (PFS) and overall survival (OS),
demonstrating a statistically significant and clinically meaningful
benefit in the overall population of patients treated with
dostarlimab plus carboplatin-paclitaxel versus chemotherapy alone.
RUBY Part 1 is the only clinical trial to show a statistically
significant survival benefit in the overall patient population. The
safety and tolerability analysis from RUBY showed a safety profile
for dostarlimab and carboplatin-paclitaxel that was generally
consistent with the known safety profiles of the individual
agents.
OS data were presented
(https://www.gsk.com/en-gb/media/press-releases/positive-ruby-phase-iii-data-show-potential-for-jemperli-dostarlimab-combinations-in-more-patients-with-primary-advanced-or-recurrent-endometrial-cancer/)
at the Society of Gynecologic Oncology (SGO) Annual Meeting on
Women's Cancer on 16 March 2024.
About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus,
known as the endometrium. Endometrial cancer is the most common
gynaecologic cancer in developed countries, with approximately
417,000 new cases reported each year worldwide1,
and incidence rates are expected to rise by almost 40% between 2020
and 2040.2,3 Approximately
15-20% of patients with endometrial cancer will be diagnosed with
advanced disease at the time of diagnosis.4 Among
patients with primary advanced or recurrent endometrial cancer,
approximately 70-75% have MMRp/MSS tumours.5
About RUBY
RUBY
is a two-part global, randomised, double-blind, multicentre phase
III trial of patients with primary advanced or recurrent
endometrial cancer. Part 1 is evaluating dostarlimab plus
carboplatin-paclitaxel followed by dostarlimab versus
carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is
evaluating dostarlimab plus carboplatin-paclitaxel followed by
dostarlimab plus niraparib versus placebo plus
carboplatin-paclitaxel followed by placebo.
In Part 1, the dual-primary endpoints are investigator-assessed PFS
based on the Response Evaluation Criteria in Solid Tumours v1.1 and
OS. The statistical analysis plan included pre-specified analyses
of PFS in the dMMR/MSI-H and overall populations and OS in the
overall population. Pre-specified exploratory analyses of PFS and
OS in the MMRp/MSS population and OS in the dMMR/MSI-H populations
were also performed. RUBY Part 1 included a broad population,
including histologies often excluded from clinical trials and had
approximately 10% of patients with carcinosarcoma and 20% with
serous carcinoma.
In Part 2, the primary endpoint is investigator-assessed PFS in the
overall population, followed by PFS in the MMRp/MSS population, and
OS in the overall population is a key secondary endpoint.
Additional secondary endpoints in Part 1 and Part 2 include PFS per
blinded independent central review, PFS2, overall response rate,
duration of response, disease control rate, patient-reported
outcomes, and safety and tolerability.
RUBY is part of an international collaboration between the European
Network of Gynaecological Oncological Trial groups (ENGOT), a
research network of the European Society of Gynaecological Oncology
(ESGO) that consists of 22 trial groups from 31 European countries
that perform cooperative clinical trials, and the GOG Foundation, a
non-profit organisation dedicated to transforming the standard of
care in gynaecologic oncology.
About Jemperli (dostarlimab)
Jemperli is a programmed
death receptor-1 (PD-1)-blocking antibody that binds to the PD-1
receptor and blocks its interaction with the PD-1 ligands PD-L1 and
PD-L2.6
In the US, Jemperli is
indicated in combination with carboplatin and paclitaxel, followed
by Jemperli as
a single agent for the treatment of adult patients with primary
advanced or recurrent endometrial cancer that is dMMR, as
determined by a US FDA-approved test, or MSI-H, and as a single
agent for adult patients with dMMR recurrent or advanced
endometrial cancer, as determined by a US FDA-approved test, that
has progressed on or following a prior platinum-containing regimen
in any setting and are not candidates for curative surgery or
radiation. The sBLA supporting this indication in combination with
carboplatin and paclitaxel for dMMR/MSI-H primary advanced or
recurrent endometrial cancer received Breakthrough Therapy
designation and Priority Review from the US
FDA. Jemperli is
also indicated in the US for patients with dMMR recurrent or
advanced solid tumours, as determined by a US FDA-approved test,
that have progressed on or following prior treatment and who have
no satisfactory alternative treatment options. The latter
indication is approved in the US under accelerated approval based
on tumour response rate and durability of response. Continued
approval for this indication in solid tumours may be contingent
upon verification and description of clinical benefit in a
confirmatory trial(s).
Jemperli was discovered by
AnaptysBio, Inc. and licensed to TESARO, Inc., under a
collaboration and exclusive license agreement signed in March 2014.
Under this agreement, GSK is responsible for the ongoing research,
development, commercialisation, and manufacturing
of Jemperli, and
cobolimab (GSK4069889), a TIM-3
antagonist.
Please see accompanying US Prescribing
Information (https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Jemperli/pdf/JEMPERLI-PI-MG.PDF).
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
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Media:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Dan
Smith
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+44 (0)
20 8047 5502
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Josh
Williams
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+44 (0)
7385 415719
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(London)
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Camilla
Campbell
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+44 (0)
7803 050238
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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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 under Item 3.D
"Risk factors" in the company's Annual Report on Form 20-F for
2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1. Faizan
U, Muppidi V. Uterine Cancer. [Updated 2022 Sep 5]. In: StatPearls
[Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan.
Available at: www.ncbi.nlm.nih.gov/books/NBK562313/.
2. Braun
MM, et al. Am Fam Physician. 2016;93(6):468-474.
3.
International Research on Cancer. Global Cancer Observatory. Cancer
Tomorrow. Gco.iarc.fr/tomorrow/en/dataviz/. Accessed 23 Apr
2024.
4. CMP:
CancerMPact® Patient Metrics Mar-2023, Cerner
Enviza. Available
at www.cancermpact.com. Accessed 23 Apr 2024.
5.
Based on CMP:CancerMPact® [Patient Metrics], Cerner Enviza.
Available from www.cancermpact.com. Accessed 23 Apr
2024.
6.
Laken H, Kehry M, Mcneeley P, et al. Identification and
characterization of TSR-042, a novel anti-human PD-1 therapeutic
antibody. European Journal of Cancer. 2016;69, S102.
doi:10.1016/s0959-8049(16)32902-1.
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: April
24, 2024
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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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