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 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: 6 June 2023, London UK
GSK receives US FDA file acceptance
for Jemperli (dostarlimab) plus chemotherapy for the
treatment of dMMR/MSI-H primary advanced or recurrent endometrial
cancer
●
Submission
accepted for Priority Review
●
Breakthrough
Therapy designation granted for this potential
indication
●
Application
being reviewed under the FDA Project Orbis framework, which enables
concurrent reviews among US, Australia, Canada, Switzerland,
Singapore and United Kingdom health authorities
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
chemotherapy for the treatment of adult patients with mismatch
repair deficient (dMMR)/microsatellite instability-high (MSI-H)
primary advanced or recurrent endometrial cancer. If approved in
this patient population, dostarlimab plus chemotherapy could
represent the first meaningful frontline treatment advancement in
decades for patients with primary advanced or recurrent endometrial
cancer.
The FDA granted Priority Review for this application and assigned a
Prescription Drug User Fee Act action date of 23 September 2023.
Dostarlimab also was recently granted Breakthrough Therapy
designation for this potential new indication.
Under Project Orbis, an initiative from the FDA Oncology Center of
Excellence that provides a framework for concurrent submission and
review of oncology products among international partners, the
dostarlimab sBLA will be reviewed by health authorities in the US,
Australia, Canada, Switzerland, Singapore and the United
Kingdom.
Hesham Abdullah, Senior Vice President, Global Head of Oncology
Development, GSK said: "We
are excited about this initial filing for this potential new
indication for dostarlimab in the patient population that
demonstrated the strongest treatment effect in the phase III RUBY
trial. Long-term outcomes for patients with primary advanced or
recurrent endometrial cancer remain poor, and there is an urgent
need to evolve the current standard of care, which is
platinum-based chemotherapy. We look forward to working with the
FDA and other health authorities as they review this
application."
Endometrial cancer is the most common gynaecologic cancer in
developed countries,[[1]] and
there are about 60,000 new cases of endometrial cancer diagnosed
every year in the US. [[2]] Approximately
15-20% of patients with endometrial cancer will be diagnosed with
advanced disease at the time of diagnosis. [[3]]
[[4]] An
estimated 20-29% of all endometrial cancers are
dMMR/MSI-H.[[5]] Chemotherapy
used alone is the current standard of care for primary advanced or
recurrent endometrial cancer, and many patients eventually
experience disease progression.[[6]]
Currently, in endometrial cancer, dostarlimab is approved in the US
as monotherapy in dMMR recurrent or advanced endometrial cancer
that has progressed on or following a prior platinum-containing
regimen. If the sBLA is approved, dostarlimab could potentially be
indicated earlier in treatment in combination with
platinum-containing chemotherapy for patients with dMMR/MSI-H
primary advanced or recurrent endometrial cancer.
The sBLA is based on the prespecified interim analysis results from
Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial. The
trial met its primary endpoint of investigator-assessed
progression-free survival (PFS), which demonstrated a statistically
significant and clinically meaningful benefit in patients treated
with dostarlimab plus carboplatin-paclitaxel in the dMMR/MSI-H
population and in the overall population. The data reflect a robust
median duration of follow-up of ≥24.8 months. 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.
These data (https://www.gsk.com/en-gb/media/press-releases/phase-iii-ruby-clinical-trial-demonstrates-potential-of-jemperli-plus-chemotherapy-to-redefine-the-treatment-of-primary-advanced-or-recurrent-endometrial-cancer)
were presented at the European Society for Medical Oncology (ESMO)
Virtual Plenary and the Society of Gynecologic Oncology (SGO)
Annual Meeting on 27 March 2023, and were simultaneously published
in The
New England Journal of Medicine.
Part 1 of the RUBY trial continues to assess the dual-primary
endpoint of overall survival (OS) in the intent-to-treat (ITT)
population. At
the first interim analysis in the ITT population, a clinically
meaningful OS trend was observed among patients receiving
dostarlimab plus chemotherapy followed by dostarlimab. The OS
analysis was done at 33% maturity and statistical significance was
not reached.
In April, the European Medicines Agency (EMA) validated
(https://www.gsk.com/en-gb/media/press-releases/european-medicines-agency-validates-marketing-authorisation-application-for-jemperli-dostarlimab)
GSK's marketing authorisation application for dostarlimab plus
chemotherapy for the treatment of dMMR/MSI-H primary advanced or
recurrent endometrial cancer.
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 dual-primary
endpoints in Part 1 are investigator-assessed progression-free
survival (PFS) based on the Response Evaluation Criteria in Solid
Tumours v1.1 and overall survival (OS). The statistical analysis
plan included pre-specified analyses of PFS in the mismatch repair
deficient (dMMR)/microsatellite instability-high (MSI-H) and
intent-to-treat (ITT) populations and OS in the overall population.
Pre-specified exploratory analyses of PFS in the mismatch repair
proficient (MMRp)/microsatellite stable (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. [[7]]
In the US, Jemperli is indicated 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 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.
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.
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
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.
GSK enquiries
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Media:
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Lyndsay
Meyer
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Investor
Relations:
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Nick
Stone
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(London)
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James
Dodwell
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Mountifield
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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, and Q1 Results for 2023 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] American
Cancer Society. Key Statistics For Endometrial Cancer.
https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html.
Updated February 14, 2022. Accessed March 29,
2023.
[3] Cerner
Enviza CancerMPact® Patient Metrics 2022.
CMP:CancerMPact® [Patient Metrics], Cerner Enviza. Available
from www.cancermpact.com. Accessed 11 May 2023.
[4] CancerMPact®
[Treatment Architecture], Cerner Enviza. Available from
www.cancermpact.com. Accessed 11 May 2023.
[5] Cerner
Enviza CancerMPact® [Treatment Architecture]. Available from
www.cancermpact.com. Accessed 14 Apr 2023.
[6] Halla
K. Emerging Treatment Options for Advanced or Recurrent Endometrial
Cancer. J Adv Pract Oncol. 2022 Jan;13(1):45-59. doi:
10.6004/jadpro.2022.13.1.4. Epub 2022 Feb 1. PMID: 35173988; PMCID:
PMC8805805.
[7] 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: June
06, 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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