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 December 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: 11 December 2023, London UK
GSK's Jemperli (dostarlimab) plus
chemotherapy approved as the first and only frontline
immuno-oncology treatment in the European Union for dMMR/MSI-H
primary advanced or recurrent endometrial cancer
● European Commission also converts previous
conditional approval for Jemperli to full approval as a monotherapy for
second-line dMMR/MSI-H recurrent or advanced endometrial
cancer
GSK plc (LSE/NYSE: GSK) today announced the
European Commission (EC) has granted marketing authorisation
for 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. Additionally, with the authorisation in this
indication, the EC's conditional approval
for Jemperli 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 is now converted to full
approval.
Hesham Abdullah, Senior Vice
President, Global Head Oncology,
R&D, GSK, said: "People living with this type of endometrial
cancer typically experience disease progression and poor-long term
outcomes with current standard of care. With this approval, we can
expand the number of patients who can potentially benefit from
treatment with Jemperli in Europe, including patients who are
earlier in their journey. We are proud of the recent approvals
for Jemperli as we believe that it continues to
transform the frontline endometrial cancer treatment landscape and
shows promise as a foundational immuno-oncology
therapy."
Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University
Hospital, Denmark and RUBY principal investigator,
said: "Today's European Commission approval is welcomed
news as I believe it will define a new standard of care for certain
patients with advanced or recurrent endometrial cancer in the EU.
The results from the RUBY trial, which led to this approval,
underscore the practice-changing potential of dostarlimab for these
patients."
The EC
authorisation of Jemperli is based on interim
analysis results from the dMMR/MSI-H population of Part 1 of
the RUBY/ENGOT-EN6/GOG3031/NSGO
phase III trial,
which reflected a robust median duration of follow-up of ≥ 25
months. The
trial met its primary endpoint of investigator-assessed
progression-free survival (PFS), demonstrating a statistically
significant and clinically meaningful benefit in patients treated
with Jemperli plus
carboplatin and paclitaxel in the dMMR/MSI-H population. In this
population, a 72% reduction in the risk of disease progression or
death was observed relative to chemotherapy alone (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 Jemperli 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]).
Results
were presented 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.
PFS is
one of two primary endpoints in the RUBY Part 1 trial. In a
subsequent planned analysis, the RUBY trial met its other primary
endpoint of OS, demonstrating a statistically significant and
clinically meaningful benefit in the overall patient
population.
The
safety and tolerability profile for Jemperli 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 Jemperli plus chemotherapy were
rash, hypothyroidism (underactive thyroid), increased alanine
aminotransferase or increased aspartate aminotransferase (increased
liver enzyme levels in the blood), pyrexia (fever) and dry
skin.
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% 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] 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 overall populations and OS in the
overall population. Pre-specified exploratory analyses of PFS and
OS 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.
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. [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.
Under this agreement, GSK is responsible for the ongoing research,
development, commercialisation, and manufacturing
of Jemperli, as well as cobolimab (GSK4069889), a TIM-3
antagonist.
Important Information for Jemperli in the EU
Indication
Jemperli is indicated:
●
in
combination with carboplatin-paclitaxel, 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;
●
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.
GSK enquiries
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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 Q3 Results for 2023.
Registered
in England & Wales:
No.
3888792
Registered
Office:
980 Great West
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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] 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: December
11, 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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