Form 6-K GSK PLC For: Dec 02
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 2022
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
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 2 December 2022, London UK
Jemperli (dostarlimab)
RUBY phase III trial met its primary endpoint in a planned interim
analysis in patients with primary advanced or recurrent endometrial
cancer
●
Regulatory submissions based on the trial results are planned for
the first half of 2023
GSK plc (LSE/NYSE: GSK) today announced positive headline results
from the planned interim analysis of Part 1 of the
RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial
investigating Jemperli (dostarlimab)
plus standard-of-care chemotherapy (carboplatin-paclitaxel)
followed by Jemperli compared
to chemotherapy plus placebo followed by placebo in
adult patients with primary advanced or recurrent endometrial
cancer. The trial met its primary endpoint of investigator-assessed
progression-free survival (PFS). It showed a statistically
significant and clinically meaningful benefit in the prespecified
mismatch repair deficient (dMMR)/microsatellite instability-high
(MSI-H) patient subgroup and in the overall population. A
clinically relevant benefit in PFS was also observed in the
mismatch repair proficient (MMRp)/microsatellite stable (MSS)
patient subgroup.
While the overall survival (OS) data were immature at the time of
this analysis, a favourable trend was observed in the overall
population, including both the dMMR/MSI-H and MMRp/MSS
subgroups.
The safety and tolerability profile of dostarlimab in the RUBY
phase III trial was consistent with clinical trials of similar
regimens. The most common treatment-emergent adverse events in
patients receiving dostarlimab plus chemotherapy were nausea,
alopecia, fatigue, peripheral neuropathy, anaemia, arthralgia,
constipation and diarrhoea.
Hesham Abdullah, Senior Vice President, Global Head of Oncology
Development, GSK, said: "Patients
with primary advanced or recurrent endometrial
cancer have limited treatment options. Long-term outcomes remain
poor, and new treatment options are urgently needed to evolve the
current standard of care, which is platinum-based chemotherapy.
Based on these positive headline results
from the RUBY phase III trial, GSK intends to seek regulatory
approvals for a potential new indication for dostarlimab in the
treatment of primary advanced or recurrent endometrial
cancer."
Regulatory submissions based on the trial results are anticipated
in the first half of 2023. Full results from the trial will be
published in a medical journal and presented at an upcoming
scientific meeting.
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 endometrial cancer
Endometrial cancer is found in the inner lining of the uterus,
known as the endometrium. It is the most common gynaecologic cancer
in the US and the second most common gynaecologic cancer
globally.[i] Approximately
15-20% of women with endometrial cancer will be diagnosed with
advanced disease at the time of diagnosis.[ii]
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. 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.[iii] Dostarlimab
is being investigated in registrational enabling studies, as
monotherapy and as part of combination regimens, including in women
with recurrent or primary advanced endometrial cancer, women with
Stage III or IV non-mucinous epithelial ovarian cancer, and
patients with other advanced solid tumours or metastatic
cancers.
In the US, dostarlimab is
indicated for adult patients with dMMR recurrent or advanced
endometrial cancer, as determined by an FDA-approved test, that
have progressed on or following prior treatment with a
platinum-containing regimen. Dostarlimab is
also indicated in the US for patients with dMMR recurrent or
advanced solid tumours, as determined by an FDA-approved test, that
have progressed on or following prior treatment and who have no
satisfactory alternative treatment options. These
indications are approved in the US under accelerated approval based
on tumour response rate and durability of response. Continued
approval for these indications may be contingent upon verification
and description of clinical benefit in a confirmatory
trial(s).
Dostarlimab was discovered by AnaptysBio 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:
dostarlimab (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.
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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Media:
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Lyndsay
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(Washington
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Investor
Relations:
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Nick
Stone
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James
Dodwell
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Mick
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Jeff
McLaughlin
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751 7002
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(Philadelphia)
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Frannie
DeFranco
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751 4855
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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 in the Company's
Annual Report on Form 20-F for 2021, GSK's Q3 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
[i] Braun
MM, et al. Am Fam
Physician. 2016;93(6):468-474.
[ii] Kantar
Health, Cust Study (2018).
[iii] 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
02, 2022
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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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