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 2023
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:
25 April 2023, London UK
European Medicines Agency validates marketing authorisation
application for Jemperli (dostarlimab) plus chemotherapy for the
treatment of dMMR/MSI-H primary advanced or recurrent endometrial
cancer
●
Regulatory
submission based on pivotal data from Part 1 of the RUBY phase III
trial
GSK plc (LSE/NYSE: GSK) today
announced that the European Medicines Agency (EMA) validated the
Company's Type II Variation for a potential new indication
for Jemperli (dostarlimab)
in combination with chemotherapy for the treatment of adult
patients with a type of gynaecological cancer known as mismatch
repair deficient (dMMR)/microsatellite instability-high
(MSI-H) primary advanced or recurrent endometrial cancer. As a
result, the EMA's Committee for Medicinal Products for Human Use
will begin the formal review process to make a recommendation to
the European Commission regarding marketing authorisation for the
potential new indication.
The regulatory submission is based on the interim
results of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial. The
trial met its primary endpoint of investigator-assessed
progression-free survival, showing a statistically significant and
clinically meaningful benefit versus placebo plus chemotherapy in
patients treated with dostarlimab plus carboplatin-paclitaxel in
the dMMR/MSI-H population. In
addition, the safety and tolerability profile of dostarlimab in
combination with carboplatin-paclitaxel was generally consistent
with the known safety profiles of the individual
agents. The results were
presented on 27 March 2023 at a European Society for Medical
Oncology Virtual Plenary and the Society of Gynecologic Oncology
Annual Meeting and simultaneously published
in The
New England Journal of Medicine.
Hesham
Abdullah, Senior Vice President, Global Head of Oncology
Development, GSK said:
"New treatment options are urgently needed for patients with
primary advanced or recurrent endometrial cancer. With this initial
filing, we are accelerating the submission of a potential new
indication for dostarlimab in the patient population that
demonstrated the strongest treatment effect in the RUBY phase III
trial. These patients currently
face significant unmet medical needs, and this combination could
change the treatment paradigm for this condition. The RUBY phase
III trial continues to follow patients for the dual-primary
endpoint of overall survival in the intent-to-treat
population."
GSK
expects US regulatory filing review based on the RUBY Phase III
trial results to occur in the first half of 2023.
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
worldwide[[1]],
and incidence rates are expected to rise by almost 40% by
2040.[[2]][[3]] Approximately
15-20% of patients with endometrial cancer will be diagnosed with
advanced disease at the time of diagnosis.[[4]]
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. The primary endpoints
in Part 1 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 ITT populations and OS in the overall population.
Pre-specified exploratory analyses of PFS 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. Secondary endpoints in Part 1 and Part 2
include PFS per blinded independent central review, overall
response rate, duration of response, disease control rate,
patient-reported outcomes, and safety and
tolerability.
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.[[5]]
Jemperli is
not approved anywhere in the world for use in combination with
standard-of-care chemotherapy (carboplatin-paclitaxel) followed by
dostarlimab for primary advanced or recurrent endometrial cancer.
In the US, Jemperli is
approved for adult patients with mismatch repair deficient (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. 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 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. The collaboration has resulted in three monospecific antibody
therapies that have progressed into the clinic. These
are: Jemperli (GSK4057190),
a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and
GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing
research, development, commercialisation, and manufacturing of each
of these medicines under the agreement.
Important Information for Jemperli in the EU
Indication
Jemperli is
indicated as monotherapy for treating adult patients with mismatch
repair deficient (dMMR)/microsatellite instability-high (MSI-H)
recurrent or advanced endometrial cancer that has progressed on or
following prior treatment with a platinum-containing
regimen.
Refer to the Jemperli EMA
Reference Information for
a full list of adverse events and the complete important safety
information in the EU.
GSK in oncology
GSK
is committed to maximising patient survival through
transformational medicines. GSK's pipeline is focused on
immuno-oncology, tumour cell targeting therapies and synthetic
lethality. Our goal is to achieve a sustainable flow of new
treatments based on a diversified portfolio of investigational
medicines utilising modalities such as small molecules, antibodies,
and antibody-drug conjugates, either alone or in
combination.
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/company.
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GSK
enquiries
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Media:
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Tim
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Dan
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(London)
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603 5003
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(Washington
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Lyndsay
Meyer
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
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(London)
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James
Dodwell
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+44 (0)
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(London)
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Mick
Readey
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Josh
Williams
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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
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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
2022, GSK's Q4 Results for 2022 and any impacts of the COVID-19
pandemic.
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:
https://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.
https://gco.iarc.fr/tomorrow/en/dataviz/. Accessed
13 July 2022.
[4] Kantar
Health, Cust Study (2018).
[5] 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
25, 2023
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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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