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 June, 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: 3
June 2024, London UK
Jemperli (dostarlimab)
trial continues to show unprecedented results with no evidence of
disease in 100% of patients with locally advanced mismatch repair
deficient (dMMR) rectal cancer
● Updated
analysis from Memorial Sloan Kettering Cancer Center presented at
ASCO 2024 has expanded to 42 patients with clinical complete
response
● New
treatment options are needed for patients facing negative impacts
to quality-of-life with current standard of
care
● Additional
registrational studies of dostarlimab in dMMR/microsatellite
instability-high rectal (MSI-H) and colorectal cancer are
recruiting
GSK plc (LSE/NYSE: GSK) today announced updated, longer-term
results from the phase II supported collaborative study with
Memorial Sloan Kettering Cancer Center (MSK)
evaluating Jemperli (dostarlimab) as
a first-line treatment-as an alternative to surgery-for mismatch
repair deficient (dMMR) locally advanced rectal
cancer. The
trial showed an unprecedented 100% clinical complete response rate
(cCR) in 42 patients who completed treatment with dostarlimab,
defined as complete pathologic response or no evidence of
tumours as assessed by magnetic resonance imaging, endoscopy and
digital rectal exam. In the first 24 patients evaluated, a
sustained clinical complete response with a median follow-up of
26.3 months (95% CI: 12.4-50.5) was observed.
These late-breaking data are being presented today at the 2024
American Society of Clinical Oncology (ASCO) Annual Meeting (31 May
- 4 June) in Chicago, IL as a rapid oral presentation (abstract
LBA3512). The latest research presented today from the phase II
trial builds on the findings initially presented in a late-breaking
presentation at the 2022 ASCO Annual Meeting with simultaneous
publication in The New England Journal of
Medicine.1
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "The
data showing no evidence of disease in 42 patients is remarkable.
These results bring us one step closer to understanding the
potential of dostarlimab in this curative-intent setting for
patients with dMMR locally advanced rectal
cancer. We
look forward to evaluating dostarlimab in certain colorectal
cancers in our ongoing AZUR-1 and AZUR-2 registrational
studies."
The current standard of care (SoC) for patients with
dMMR/microsatellite instability-high (MSI-H) locally advanced
rectal cancer is initial treatment with chemotherapy plus radiation
followed by surgery to remove the tumour along with portions of the
intestine and/or surrounding tissue.1 This
results in initial positive outcomes for most patients, but nearly
one-third ultimately die from cancer that has spread to other parts
of the body (distant metastasis).2 Additionally,
the surgery and chemoradiotherapy associated with SoC can lead to
long-term adverse effects that have a significantly negative impact
on quality of life, including bowel, urinary and sexual
dysfunction, secondary cancers and infertility.1
Andrea Cercek, MD, Section Head of Colorectal Cancer and
Co-Director of the Center for Young Onset Colorectal and
Gastrointestinal Cancer, MSK, and Principal Investigator of the
phase II study said: "These
findings demonstrate the potential of dostarlimab as a novel
approach to treating locally advanced dMMR rectal cancer that leads
to durable complete tumour regression without the need for
life-altering treatment. As
a clinician, I've seen firsthand the debilitating impact of
standard treatment of dMMR rectal cancer and am thrilled about the
potential of dostarlimab
in these patients."
The safety and tolerability profile of dostarlimab was generally
consistent with the known safety profile of the agent. No adverse
events of grade 3 or higher were reported in this
trial.
Dostarlimab is not approved anywhere in the world for the frontline
treatment of locally advanced dMMR rectal cancer. GSK is advancing
studies evaluating dostarlimab in patients with advanced/metastatic
stages of dMMR/MSI-H colorectal cancer through its AZUR clinical
trial programme. AZUR-1 is a global, multi-centre, open-label,
phase II registrational clinical trial investigating the efficacy
and safety of dostarlimab as monotherapy - as a replacement for
chemotherapy, radiation and/or surgery - for treatment-naïve
patients with dMMR/MSI-H locally advanced rectal cancer. The AZUR-1
trial aims to confirm the findings of the supported collaborative
study in locally advanced dMMR
rectal cancer led by Dr. Cercek at MSK. AZUR-2
is a phase III trial evaluating the efficacy of perioperative
dostarlimab compared with SoC in participants with untreated T4N0
or Stage III (resectable) dMMR/MSI-H colon
cancer.
About dMMR/MSI-H rectal cancer
Rectal
cancer is a form of cancer that starts in the rectum, the final
section of the large intestine, and is often categorised as part of
a group of cancers called colorectal cancer.3 Colorectal
cancer is the third most commonly diagnosed cancer in the
world.4 In the US, it
is estimated that approximately 46,220 individuals are diagnosed
annually with rectal cancer.5 Approximately
5-10% of all rectal cancers are mismatch repair deficient
(dMMR)/microsatellite instability-high (MSI-H), meaning that they
contain abnormalities that affect the proper repair of DNA when
copied in a cell.6 Mismatch repair
deficient status is a biomarker that has been shown to predict
response to immune checkpoint blockade with PD-1
therapy.7,8 Tumours with
this biomarker are most commonly found in endometrial, colorectal
and other gastrointestinal cancers but may also be found in other
solid tumours.9-12
About Jemperli (dostarlimab)
Jemperli, a programmed death
receptor-1 (PD-1)-blocking antibody, is the backbone of GSK's
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. It
is the first and only immuno-oncology treatment approved, in
combination with chemotherapy, in the frontline setting for primary
advanced or recurrent dMMR/MSI-H endometrial
cancer.
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 dMMR, as
determined by a US FDA-approved test, or MSI-H, and 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. The sBLA supporting this indication in combination with
carboplatin and paclitaxel for dMMR/MSI-H primary advanced or
recurrent endometrial cancer received Breakthrough Therapy
designation and Priority Review from the US
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, and
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
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.
GSK enquiries
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Media:
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Tim
Foley
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Dan
Smith
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(London)
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Kathleen
Quinn
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603 5003
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(Washington
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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
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(London)
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Josh
Williams
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(London)
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Camilla
Campbell
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7803 050238
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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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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(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 under Item 3.D
"Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q1 Results for 2024.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8
9GS
Dr. Cercek has financial interests related to GSK.
References
1 Cercek
A, Lumish M, Sinopoli J, et al. PD-1 blockade in mismatch
repair-deficient, locally advanced rectal cancer. N Engl J Med
2022; 386: 2363-76.
2 Smith
JJ, et al. Rectal Cancer Consortium. Organ Preservation in Rectal
Adenocarcinoma: a phase II randomized controlled trial evaluating
3-year disease-free survival in patients with locally advanced
rectal cancer treated with chemoradiation plus induction or
consolidation chemotherapy, and total mesorectal excision or
nonoperative management. BMC Cancer. 2015 Oct 23;15:767. doi:
10.1186/s12885-015-1632-z. PMID: 26497495; PMCID:
PMC4619249.
3 Sung
H, Ferlay J, Siegel RL, 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 SEER
Explorer. SEER Explorer Application. Accessed April 19, 2024.
Available at https://seer.cancer.gov/statistics-network/explorer/.
5 Siegel
RL, Giaquinto AN, Jemal A. Cancer statistics,
2024. CA Cancer J
Clin.
2024;74(1):12-49. Doi:10.3322/caac.21820.
6 Cercek
A, et al. Mismatch Repair-Deficient Rectal Cancer and Resistance to
Neoadjuvant Chemotherapy. Clin
Cancer Res. 2020 Jul 1;26(13):3271-3279. doi:
1158/1078-0432.CCR-19-3728. Epub 2020 Mar 6. PMID: 32144135; PMCID:
PMC7348681.
7 Le
DT, et al. PD-1
blockade in tumors with mismatch repair deficiency. N Engl J Med.
2015;372(26):2509-2520.
8 Marabelle
A, et al. Efficacy of pembrolizumab in patients with noncolorectal
high microsatellite instability/mismatch repair deficient cancer:
results from the Phase II KEYNOTE-158 study. J Clin Oncol.
2020;38(1):1-10.
9 National
Cancer Institute at the National Institutes of Health. Definition
of mismatch repair deficiency. Accessed April 19, 2024. Available
at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mismatch-repair-deficiency.
10 Lorenzi
M, et al. Epidemiology of microsatellite instability high (MSI-H)
and deficient mismatch repair (dMMR) in solid tumors: a structured
literature review. J Oncol. 2020.
doi.org/10.1155/2020/1807929.
11 Zhao
P, et al. Mismatch repair deficiency/microsatellite
instability-high as a predictor for anti-PD-1/PD-L1 immunotherapy
efficacy. J Hematol Oncol. 2019;12(1):54. doi:
10.1186/s13045-019-0738-1.
12 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: June
3, 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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