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 March 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 . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
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Issued:
27 March 2023, London UK
Phase III RUBY clinical trial
demonstrates potential of Jemperli (dostarlimab) plus chemotherapy to redefine
the treatment of primary advanced or recurrent endometrial cancer
versus chemotherapy alone
●
72%
and 36% reduction in the risk of disease progression or death
observed in the dMMR/MSI-H population and overall patient
population, respectively
●
Clinically
meaningful overall survival trend observed at interim
analysis
●
Results
presented in same-day presentations at ESMO Virtual Plenary and SGO
Annual Meeting and simultaneously published
in The New
England Journal of Medicine
●
Regulatory
submissions planned for the first half of 2023
GSK plc (LSE/NYSE: GSK) today announced interim results from Part 1
of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial
investigating Jemperli (dostarlimab) plus standard-of-care
chemotherapy (carboplatin-paclitaxel) followed by dostarlimab
compared to chemotherapy plus placebo followed by placebo in adult
patients with primary advanced or recurrent endometrial
cancer.
Hesham Abdullah, Senior Vice President, Global Head of Oncology
Development, GSK said:
"These positive results from the RUBY trial bring us one step
closer to addressing the significant unmet needs of endometrial
cancer patients and add to the growing body of evidence on
dostarlimab, strengthening our belief in its potential to transform
cancer treatment as a backbone immuno-oncology
therapy."
A statistically significant and clinically meaningful improvement
in progression free survival (PFS) was observed for dostarlimab
plus carboplatin-paclitaxel in the mismatch repair deficient
(dMMR)/microsatellite instability-high (MSI-H) population (n=118)
and in the overall population (n=494) versus placebo plus
chemotherapy. The
separation of the lines in the Kaplan-Meier curve below illustrates
the significant reduction in risk of disease progression or death
in patients with dMMR/MSI-H primary advanced or recurrent
endometrial cancer in the dostarlimab plus chemotherapy treatment
arm compared to the placebo plus chemotherapy treatment
arm.
http://www.rns-pdf.londonstockexchange.com/rns/3880U_1-2023-3-27.pdf
Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University
Hospital, Denmark and RUBY principal
investigator, said: "Clinical
practice has been waiting decades for a meaningful advancement in
the standard of care for primary advanced or recurrent endometrial
cancer. The results from the RUBY clinical trial, especially given
the difficult-to-treat histologies included in the trial,
demonstrate support for a new treatment standard with the addition
of dostarlimab to current standard-of-care
chemotherapy."
Additionally, at this first interim analysis, there was a
clinically meaningful overall survival (OS) trend in the overall
population among
patients receiving dostarlimab plus chemotherapy followed by
dostarlimab. The analysis was done at 33% maturity and statistical
significance was not reached. OS follow-up continues and further
analysis is planned. PFS
and OS summaries are listed below.
|
dostarlimab + chemotherapy
|
placebo + chemotherapy
|
PFS
dMMR/MSI-H population
|
Number
of patients evaluated
|
53
|
65
|
HR (95%
CI)
|
0.28
(0.162-0.495)
|
P-value
|
P<0.0001
|
At 24
months (95% CI)
|
61.4%
(46.3-73.4)
|
15.7%
(7.2-27.0)
|
PFS
overall patient population
|
Number
of patients evaluated
|
245
|
249
|
HR (95%
CI)
|
0.64(0.507-0.800)
|
P-value
|
P<0.0001
|
At 24
months (95% CI)
|
36.1%
(29.3%-42.9%)
|
18.1%
(13.0%-23.9%)
|
PFS
mismatch repair proficient (MMRp)/microsatellite stable (MSS)
populationa
|
Number
of patients evaluated
|
192
|
184
|
HR (95%
CI)
|
0.76(0.592-0.981)
|
P-value
|
N/A
|
At 24
months (95% CI)
|
28.4%
(21.2-36.0)
|
18.8%
(12.8-25.7)
|
OS
overall patient populationb
|
HR (95%
CI)
|
0.64(0.46-4-0.870)
|
P-value
|
P=0.0021c
|
At 24
months (95% CI)
|
71.3%
(64.5-77.1)
|
56.0%(48.9-62.5)
|
OS
dMMR/MSI-H populationa,d
|
HR (95%
CI)
|
0.30
(0.127-0.699)
|
P-value
|
N/A
|
At 24
months (95% CI)
|
83.3%
(66.8-92.0)
|
58.7%
(43.4-71.2)
|
OS
MMRp/MSS populationa,e
|
HR (95%
CI)
|
0.73(0.515-1.024)
|
P-value
|
N/A
|
At 24
months (95% CI)
|
67.7%
(59.8-74.4)
|
55.1%
(46.8-62.5)
|
aExploratory
analyses of PFS in MMRp/MSS, OS in dMMR/MSI-H, and OS in MMRp/MSS
populations were pre-specified with no planned hypothesis
testing. bMaturity
≈33%. cP-value
of ≤0.00177 was required for statistical significance at this
OS interim analysis. dMaturity
≈26%. eMaturity
≈36%.
The safety and tolerability profile of dostarlimab in combination
with carboplatin-paclitaxel in the RUBY phase III trial was
generally consistent with the known safety profiles of the
individual agents. The most common (>45%) treatment-emergent
adverse events (TEAEs) in both treatment arms in the dMMR/MSI-H and
overall populations were nausea, alopecia and fatigue, as well as
anaemia in the placebo plus chemotherapy arm in the dMMR/MSI-H
population. Severe and serious TEAEs were approximately 10% higher
in the dostarlimab plus carboplatin-paclitaxel arm compared with
the placebo plus carboplatin-paclitaxel arm in the overall
population. The nature and types of immune-related adverse events
(irAEs) in the dostarlimab plus chemotherapy safety profile were
consistent with the mechanism of action of dostarlimab and similar
to those reported for other PD-(L)1 inhibitors. In the overall
population, 38.2% of participants in the dostarlimab plus
carboplatin-paclitaxel arm and 15.4% of participants in the placebo
plus carboplatin-paclitaxel arm had irAEs assessed by the
investigator as related to dostarlimab or placebo, respectively.
The most frequently reported dostarlimab-related irAE categories
were endocrinopathies (15.8% dostarlimab-related versus 3.3%
placebo-related) and skin adverse reactions (14.1%
dostarlimab-related versus 3.7% placebo-related). Discontinuation
of dostarlimab or placebo due to a TEAE occurred in 17.4% of
patients in the dostarlimab plus chemotherapy treatment arm and
9.3% of patients in the placebo plus chemotherapy treatment arm in
the overall population.
These data were shared in a European Society for Medical Oncology
(ESMO) Virtual Plenary, presented in a late breaking session at the
Society of Gynecologic Oncology (SGO) Annual Meeting on Women's
Cancer (25-28 March) and published simultaneously
in The New England Journal of
Medicine.
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; the GOG Foundation, a
non-profit organisation dedicated to transforming the standard of
care in gynaecologic oncology; and the Nordic Society of
Gynaecological Oncology - Clinical Trial Unit (NSGO-CTU), a
non-profit organisation aiming to improve the practice of
prevention, diagnosis and treatment for gynaecological cancers by
supporting research and conducting clinical trials across
countries.
GSK's ambition is for dostarlimab to become the backbone of the
Company's ongoing immuno-oncology-based research and development
programme when used alone and in combination with standard of care
and future novel cancer therapies, particularly for patients who
currently have limited treatment options. Dostarlimab is being
investigated in registrational enabling studies as monotherapy and
as part of combination regimens, including in patients with primary
advanced or recurrent endometrial cancer, patients with Stage III
or IV non-mucinous epithelial ovarian cancer, and patients with
other advanced solid tumours or metastatic cancers.
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[[i]],
and incidence rates are expected to rise by almost 40% by
2040.[[ii]][[iii]] Approximately
15-20% of patients with endometrial cancer will be diagnosed with
advanced disease at the time of diagnosis.[[iv]]
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.[[v]]
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
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.
Important Information for Jemperli in
the EU
Indication
Dostarlimab is indicated as monotherapy for the treatment of 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
GSK enquiries
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Investor
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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
[i] 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/.
[ii] Braun
MM, et al. Am Fam Physician. 2016;93(6):468-474.
[iii] International
Research on Cancer. Global Cancer Observatory. Cancer Tomorrow.
https://gco.iarc.fr/tomorrow/en/dataviz/. Accessed
13 July 2022.
[iv] Kantar
Health, Cust Study (2018).
[v] 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.
|
GSK plc
|
|
(Registrant)
|
|
|
Date: March
28, 2023
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GSK plc
|
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