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 August 2024
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: 1 August 2024, London UK
US FDA
expands Jemperli (dostarlimab)
plus chemotherapy approval to all adult patients with primary
advanced or recurrent endometrial cancer as the first and only
immuno-oncology-based treatment to show an overall survival
benefit
●
Jemperli approval now includes MMRp/MSS tumours,
which represent majority of endometrial cancer
cases
●
Jemperli plus chemotherapy demonstrated a
statistically significant and clinically meaningful 31% reduction
in risk of death versus chemotherapy alone
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug
Administration (FDA) has approved Jemperli (dostarlimab) in combination with
carboplatin and paclitaxel (chemotherapy) followed
by Jemperli as a single agent for the treatment of
adult patients with primary advanced or recurrent endometrial
cancer. This approval broadens the previous indication
for Jemperli plus chemotherapy to include patients with
mismatch repair proficient (MMRp)/microsatellite stable (MSS)
tumours who represent 70-75% of patients diagnosed with endometrial
cancer and who have limited treatment options. The supplemental
Biologics License Application (sBLA) supporting this expanded
indication received Priority Review and was approved ahead of the
Prescription Drug User Fee Act action date.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: ÒJemperli plus chemotherapy is the first and only
immuno-oncology regimen to show significant and meaningful
improvement in overall survival for adult patients with primary
advanced or recurrent endometrial cancer regardless of biomarker
status. We are thrilled this option is now available for more
patients in the US, including the 70-75% with MMRp/MSS tumours
where treatment options have been
limited.Ó
TodayÕs expanded approval is based on results from dual
primary endpoints of investigator-assessed progression-free
survival (PFS) and overall survival (OS) from Part 1 of the RUBY
phase III trial. RUBY Part 1 is the only clinical trial in this
setting to show a statistically significant OS benefit in the full
population of patients with primary advanced or recurrent
endometrial cancer, demonstrating a 31% reduction in
risk of death (HR: 0.69; 95% CI: 0.54Ð0.89) compared to
chemotherapy alone.
At the 2.5-year landmark, 61% (95% CI: 54-67) of patients in
the Jemperli plus chemotherapy group compared to 49% (95%
CI: 43-55) in the chemotherapy group were alive. In addition, a
16.4-month improvement in median OS was observed
with Jemperli plus chemotherapy versus chemotherapy alone
(44.6 months [95% CI: 32.6ÐNR] vs. 28.2 months [95% CI:
22.1Ð35.6], respectively). The median duration of follow-up
was more than three years.[1] The
safety and tolerability analysis from RUBY Part 1 showed a safety
profile for Jemperli and carboplatin-paclitaxel that was
generally consistent with the known safety profiles of the
individual agents. The most common treatment-emergent adverse
events (³ 20%) in patients receiving Jemperli plus chemotherapy were nausea, alopecia,
fatigue, peripheral neuropathy, anaemia, arthralgia, constipation,
diarrhoea, myalgia, rash, hypomagnesemia, decreased appetite,
peripheral sensory neuropathy and vomiting.
Matthew Powell, MD, Chief, Division of Gynecologic Oncology,
Washington University School of Medicine, and US principal
investigator of the RUBY trial said: ÒThe initial approval
of Jemperli plus chemotherapy was practice-changing for
patients with dMMR/MSI-H primary advanced or recurrent endometrial
cancer and todayÕs expanded approval will offer even more
patients the opportunity for improved outcomes. This is the only
immuno-oncology treatment regimen that has shown a statistically
significant overall survival benefit for the full patient
population, which is a meaningful step forward in treating this
challenging cancer.Ó
Adrienne Moore, Survivor, Founding Member and President of
Endometrial Cancer Action Network for African-Americans (ECANA)
said: ÒWith this
expanded approval for Jemperli plus chemotherapy, GSK is bringing a
much-needed new treatment regimen to the endometrial cancer
community that may help patients with primary advanced or recurrent
endometrial cancer live longer, providing hope to patients and
their families. Survivors and advocates should be excited by
todayÕs news and especially delighted that this approval means
that more patients in the US who are diagnosed with endometrial
cancer will have a new treatment option.Ó
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,[2] with an
estimated 1.6 million people living with active disease at any
stage and 417,000 new cases reported each year
worldwide.[3] Incidence
rates are expected to rise by approximately 40% between 2020 and
2040.[4] Approximately
15-20% of patients with endometrial cancer will be diagnosed with
advanced disease at the time of diagnosis.[5] Among
patients with primary advanced or recurrent endometrial cancer,
approximately 70-75% have MMRp/MSS tumours.[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.
In Part 1, the dual-primary endpoints 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 mismatch repair deficient (dMMR)/microsatellite
instability-high (MSI-H) and overall populations and OS in the
overall population. Pre-specified exploratory analyses of PFS and
OS 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 in the
overall population, followed by PFS in the MMRp/MSS population, and
OS in the overall population is a key secondary endpoint.
Additional secondary endpoints in Part 1 and Part 2 include PFS per
blinded independent central review, PFS2, 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, a programmed death receptor-1 (PD-1)-blocking
antibody, is the backbone of GSKÕs ongoing
immuno-oncology-based research and development programme. A robust
clinical trial programme includes studies
of Jemperli alone and in combination with other
therapies in gynaecologic, colorectal and lung cancers, as well as
where there are opportunities for transformational
outcomes.
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.
This includes patients with MMRp/MSS and dMMR/MSI-H
tumours. Jemperli is also approved as a single agent for adult
patients with 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.
Additionally, Jemperli is 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 and cobolimab (GSK4069889), a TIM-3
antagonist.
Please see accompanying US Prescribing Information:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Jemperli/pdf/JEMPERLI-PI-MG.PDF.
GSK in oncology
Oncology
is an emerging therapeutic area for GSK where we are committed to
maximising patient survival with a current focus on haematologic
malignancies, gynaecologic cancers and other solid tumours through
breakthroughs in immuno-oncology and tumour-cell targeting
therapies.
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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Investor Relations:
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Nick Stone
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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
ÒRisk factorsÓ in GSKÕs Annual Report on Form 20-F
for 2023, and GSKÕs Q2 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
[1] Powell MA, Bj¿rge
L, Willmott L, et al. Overall survival in patients with
endometrial cancer treated with dostarlimab plus
carboplatin-paclitaxel in the randomized ENGOT-EN6/GOG-3031/RUBY
trial, Annals of Oncology.2024. doi: https://
doi.org/10.1016/j.annonc.2024.05.546.
[2] Faizan U, Muppidi V.
Uterine Cancer. [Updated 2022 Sep 5]. In: StatPearls [Internet].
Treasure Island (FL): StatPearls Publishing; 2022 Jan. Available
at:
www.ncbi.nlm.nih.gov/books/NBK562313/.
[3] 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;71(3):209-249.
doi:10.3322/caac.21660
[4] International Research
on Cancer. Global Cancer Observatory. Cancer Tomorrow.
Gco.iarc.fr/tomorrow/en/dataviz/. Accessed 12 Jun
2024.
[5] CMP:
CancerMPact¨ Patient
Metrics Mar-2023, Cerner Enviza. Available at www.cancermpact.com.
Accessed 12 Jun 2024.
[6] Based
on CMP:CancerMPact¨ [Patient
Metrics], Cerner Enviza. Available from www.cancermpact.com.
Accessed 12 Jun 2024.
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: August
02, 2024
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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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