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 February 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
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
10 February 2023, London UK
US FDA grants regular approval
for Jemperli for
the treatment of patients with recurrent or advanced mismatch
repair-deficient endometrial cancer
●
Conversion
from accelerated to regular
(full) approval based
on long-term outcomes from the GARNET phase I trial, which
demonstrated an overall response rate of 45.4%
●
85.9%
of patients had duration of response ≥12 months and 54.7% of
patients had duration of response ≥24
months
GSK plc (LSE/NYSE: GSK) today reports that the US Food and Drug
Administration (FDA) granted full approval
for Jemperli (dostarlimab-gxly) for the treatment of
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.
Hesham Abdullah, Senior Vice President, Global Head of Oncology
Development, GSK, said: "This US
regulatory action confirms our confidence
in Jemperli as
an important treatment option for patients with dMMR recurrent or
advanced endometrial cancer. We continue to unlock the potential
of Jemperli as
the backbone for our immuno-oncology development programmes to
address the unmet needs of patients, including
earlier lines of endometrial cancer and other solid
tumours."
In April 2021, Jemperli received accelerated approval for the
treatment of adult patients with dMMR recurrent or advanced
endometrial cancer that had progressed on or following prior
treatment with a platinum-containing regimen.
This approval is based on additional data collected from the A1
expansion cohort of the ongoing GARNET trial, a phase I,
multicentre, open-label, single-arm study
of Jemperli monotherapy
in patients with advanced or recurrent solid tumours. Cohort A1
evaluated the efficacy of Jemperli in
141 patients with dMMR advanced or recurrent endometrial cancer
that has progressed on or following prior treatment with a
platinum-containing regimen. The major efficacy outcome measures
were overall response rate (ORR) and duration of response (DOR) as
assessed by a blinded independent central review according to
RECIST v1.1. Confirmed ORR was 45.4% (95% CI: 37.0, 54.0), with a
15.6% complete response rate and a 29.8% partial response rate.
Median DOR was not reached (range: 1.2+,
52.8+ months), measured
from the time of first response, with 85.9% of patients having
duration ≥12 months and 54.7% of patients having duration
≥24 months. Median
follow-up for duration of response was 27.9
months.
Treatment-related adverse events were consistent with previous
analyses for cohort A1. The most common adverse reactions
(≥20%) were fatigue/asthenia, anaemia, rash, nausea,
diarrhoea, constipation, and vomiting. The most common Grade 3 or 4
adverse reactions (≥2%) were anaemia, increased
transaminases, urinary tract infection, fatigue/asthenia, and
diarrhoea.
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 globally, 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]]
About GARNET
The ongoing GARNET phase I trial is
evaluating Jemperli as monotherapy in patients with advanced
solid tumours. Part 2B of the study includes five expansion
cohorts: dMMR/MSI-H endometrial cancer (cohort A1), mismatch repair
proficient/microsatellite stable (MMRp/MSS) endometrial cancer
(cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H
non-endometrial or POLE-mut solid tumour basket cohort (cohort F),
and platinum-resistant ovarian cancer
without BRCA mutations (cohort G). GARNET continues to
enrol patients.
In cohort A1, patients received 500mg of Jemperli as an intravenous infusion once every three
weeks (Q3W) for four doses, followed by 1,000mg once every six
weeks until disease progression, discontinuation or
withdrawal.
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.[[5]] GSK's
ambition is for Jemperli 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. Jemperli is
being investigated in registrational enabling studies as
monotherapy and as part of combination regimens, including in
patients with recurrent or primary advanced endometrial cancer,
patients with Stage III or IV non-mucinous epithelial ovarian
cancer, and patients with other advanced solid tumours or
metastatic cancers.
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.
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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Media:
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Meyer
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302 4595
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(Washington
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Investor
Relations:
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Nick
Stone
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7717 618834
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(London)
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James
Dodwell
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+44 (0)
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Camilla
Campbell
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(London)
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Steph
Mountifield
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(London)
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Jeff
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Frannie
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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 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
[1] Sung
H, Ferlay J, Siegel R et al. Global cancer statistics 2020:
GLOBOCAN estimates of incidence and mortality worldwide for 36
cancers in 185 countries. CA Cancer J Clin. 2021.
doi:10.3322/caac.21660.
[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] 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:
February 10, 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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