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 October 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:
16 October 2023, London UK
GSK receives positive CHMP opinion recommending approval
of Jemperli (dostarlimab) plus
chemotherapy as a new frontline treatment for dMMR/MSI-H primary
advanced or recurrent endometrial cancer
● If approved, dostarlimab would become the first
new frontline treatment option in the European Union (EU) in
decades and the only immuno-oncology combination regimen available
for this patient population with high unmet
need
● Decision on EU marketing authorisation expected
by the end of the year
GSK plc
(LSE/NYSE: GSK) today announced the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion recommending approval
of Jemperli (dostarlimab) in
combination with carboplatin-paclitaxel (chemotherapy), for the
treatment of adult patients with mismatch repair deficient
(dMMR)/microsatellite instability-high (MSI-H) primary advanced or
recurrent endometrial cancer and who are candidates for systemic
therapy. The CHMP opinion is one
of the final steps prior to a marketing authorisation decision by
the European Commission.
Hesham Abdullah, Senior Vice
President, Global Head Oncology,
R&D, GSK, said: "We are pleased with this positive CHMP opinion
and the potential for dostarlimab with chemotherapy to treat
patients with this very challenging form of endometrial cancer. If
approved, dostarlimab plus chemotherapy will be the first new
treatment option in decades for these patients in the European
Union, offering long-awaited new hope for improved long-term
outcomes. This opinion further reinforces our confidence in
dostarlimab's important role in the immuno-oncology treatment
landscape."
GSK's application for the authorisation of dostarlimab is based on
interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase
III trial, which were presented (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/)
at the European Society for Medical Oncology (ESMO) Virtual Plenary
and Society of Gynecologic Oncology (SGO) Annual Meeting on 27
March 2023, and simultaneously published
in The
New England Journal of Medicine. The trial results reflect a robust median duration of follow-up of
≥ 25 months. Part 1 of the RUBY trial met its primary endpoint
of investigator-assessed progression-free survival (PFS) in
patients treated with dostarlimab plus carboplatin and paclitaxel
in the dMMR/MSI-H population. In the dMMR/MSI-H population, a 72%
reduction in the risk of disease progression or death was observed
(HR: 0.28 [95% CI: 0.16-0.50]).
In a
prespecified, exploratory analysis of overall survival (OS) in the
dMMR/MSI-H population, the addition of dostarlimab to chemotherapy
resulted in a 70% reduction in the risk of death relative to
chemotherapy alone (HR: 0.30 [95% CI: 0.13-0.70]).
The
safety and tolerability profile for dostarlimab plus carboplatin
and paclitaxel was generally consistent with the known safety
profiles of the individual agents. The most common adverse
reactions (≥ 10%) in patients receiving dostarlimab plus
chemotherapy were rash, hypothyroidism (overactive thyroid),
increased alanine aminotransferase or increased aspartate
aminotransferase (increased liver enzyme levels in the blood),
pyrexia (fever) and dry skin.
This opinion follows the July 2023 expansion of the label
for Jemperli in the US to include this indication
(https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-chemotherapy-approved-in-us-for-new-indication/). The
new indication for Jemperli was reviewed under the FDA Oncology Center
of Excellence Project Orbis framework, which allowed for concurrent
submission to and review by US and other international regulatory
authorities. As part of Project
Orbis, Jemperli was
also approved in the United Kingdom earlier this month in
combination with platinum-containing chemotherapy for the treatment
of adult patients with dMMR/MSI-H primary advanced or recurrent
endometrial cancer and who are candidates for systemic therapy. The
application remains under review in Australia, Canada, Switzerland
and Singapore.
In the EU, Jemperli currently has conditional approval as a
monotherapy for treating adult patients with dMMR/MSI-H recurrent
or advanced endometrial cancer that has progressed on or following
prior treatment with a platinum-containing regimen. If the European
Commission approves the frontline
indication for Jemperli +
chemotherapy, this conditional approval is
expected to be converted to full approval at the same time. A
decision is expected by the end of this year.
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] An estimated 20-29% of all endometrial cancers
are dMMR/MSI-H[5]. In the EU4 (France, Germany, Italy and Spain),
approximately 3,000 people are estimated to be diagnosed with
dMMR/MSI-H primary advanced or recurrent endometrial cancer each
year[6].
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 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 ITT
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 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 mismatch repair
deficient (dMMR), as determined by an FDA-approved test, or
microsatellite instability-high (MSI-H), and as a single agent 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. The sBLA supporting the new
indication in combination with carboplatin and paclitaxel received
Breakthrough Therapy designation from the
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. 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
here: https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli
GSK in oncology
GSK is
committed to maximising patient survival through transformational
medicines, with a current focus on breakthroughs in immuno-oncology
and tumour-cell targeting therapies, and development in
haematologic malignancies, gynaecologic cancers and other solid
tumours.
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.
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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 Q2 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered
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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] Cerner Enviza CancerMPact® [Treatment
Architecture]. Available from www.cancermpact.com. Accessed 14 Apr
2023.
[6] Based on CMP:CancerMPact® [Patient Metrics],
Cerner Enviza. Available from www.cancermpact.com.
Accessed 28 Sept 2023.
[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: October
16, 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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