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): ____
9 February 2023, London UK
US FDA Advisory Committee votes in
support of trials designed to evaluate Jemperli (dostarlimab-gxly) as a potential treatment
for mismatch repair-deficient/microsatellite instability-high
locally advanced rectal cancer
●
US FDA also recently
granted Fast Track designation to Jemperli in
this patient population
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) Oncologic Drugs Advisory Committee (ODAC)
voted 8 to 5 in support of the question posed to the committee
regarding whether data from two proposed single-arm trials will be
"sufficient to characterize the benefits and risks"
of Jemperli (dostarlimab-gxly) in the curative-intent
setting for patients with mismatch repair-deficient/microsatellite
instability-high (dMMR/MSI-H) locally advanced rectal
cancer.
Hesham Abdullah, Senior Vice President, Global Head of Oncology
Development, GSK, said: "The
Committee's positive vote in favour of our proposed clinical trial
programme for dostarlimab reinforces our plans to generate data in
support of a future US regulatory submission for the potential
treatment of patients with dMMR/MSI-H locally advanced rectal
cancer, a patient population with significant unmet medical needs
and a standard of care that results in serious quality of life
concerns. We thank the committee for the constructive dialogue and
we look forward to continued interactions with FDA as we progress
our development programme."
The current standard of care (SoC) for patients with dMMR/MSI-H
locally advanced rectal cancer is neoadjuvant chemoradiotherapy
(CRT) followed by surgery and adjuvant
chemotherapy.[i] Neoadjuvant
CRT provides local tumour control in most patients, but nearly
one-third ultimately die from distant metastasis[ii].
Additionally, SoC is associated with long-term adverse effects,
including bowel, urinary and sexual dysfunction, secondary
malignancy and infertility i.
As part of its proposed clinical trial programme, GSK is initiating
a global, open-label, phase II clinical trial to investigate the
efficacy and safety of dostarlimab-gxly as monotherapy - as a
replacement for chemotherapy, radiation and/or surgery - for
treatment-naïve patients with dMMR/MSI-H locally advanced
rectal cancer. The primary endpoint of GSK's proposed trial is
clinical complete response for 12 months (cCR12) as assessed by
Independent Central Review. Key secondary endpoints will include
cCR for 36 months and event-free survival for three years by
investigator assessment. In addition, the trial aims to confirm
results generated in a separate ongoing investigator-initiated
trial by researchers at Memorial Sloan Kettering Cancer Center
(MSK). Researchers at MSK shared these findings in a late-breaking
presentation at the 2022 American Society of Clinical Oncology
(ASCO) Annual Meeting with simultaneous publication
in The New
England Journal of Medicine.i GSK
intends to use data from the Company's proposed trial, alongside
data from MSK's ongoing trial of 30 patients, to support a
supplemental Biologics License Application (sBLA) for accelerated
regulatory approval in this indication.
In January 2023, the US FDA granted dostarlimab-gxly Fast Track
designation for the treatment of dMMR/MSI-H locally advanced rectal
cancer. Fast
Track designation is designed to accelerate the development and
expedite the review of potential new medicines to treat serious
conditions with unmet medical needs. In
addition, the application could be eligible for priority review if
supported by clinical data at the time of the submission to the
FDA.
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. Colorectal
cancer is the third most commonly diagnosed cancer in the
world.[iii] In
the US, it is estimated that approximately 20,220 individuals are
diagnosed annually with rectal cancer[iv].
Approximately 5-10% of all rectal cancers are dMMR/MSI-H, meaning
that they contain abnormalities that affect the proper repair of
DNA when copied in a cell.[v] Mismatch
repair-deficient status is a biomarker that has been shown to
predict response to immune checkpoint blockade with PD-1
therapy.[vi] [vii] Tumours
with this biomarker are most commonly found in endometrial,
colorectal and other gastrointestinal cancers but may also be found
in other solid tumours.[viii] [ix] [x]
About Jemperli (dostarlimab-gxly)
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.[xi] 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 in patients with currently
limited treatment options. Dostarlimab is being investigated in
registrational enabling trials 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. Dostarlimab
has not been approved anywhere in the world as monotherapy for
treatment-naïve patients with dMMR/MSI-H locally advanced
rectal cancer. The
US FDA has granted dostarlimab Fast Track designation for the
treatment of dMMR/MSI-H locally advanced rectal
cancer.
Dostarlimab 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: 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
Jemperli 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 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 oncology 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
|
|
|
|
Media:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
Dan
Smith
|
+44 (0)
20 8047 5502
|
(London)
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
Lyndsay
Meyer
|
+1 202
302 4595
|
(Washington
DC)
|
|
|
|
|
Investor
Relations:
|
Nick
Stone
|
+44 (0)
7717 618834
|
(London)
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
|
|
Josh
Williams
|
+44 (0)
7385 415719
|
(London)
|
|
Camilla
Campbell
|
+44 (0)
7803 050238
|
(London)
|
|
Steph
Mountifield
|
+44 (0)
7736 063933
|
(London)
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
Frannie
DeFranco
|
+1 215
751 4855
|
(Philadelphia)
|
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
[i] 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.
[ii] 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.
[iii] 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
[iv] SEER
Explorer. SEER Explorer Application. Accessed February 9, 2023,
from https://seer.cancer.gov/statistics-network/explorer/.
[v] 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:
10.1158/1078-0432.CCR-19-3728. Epub 2020 Mar 6. PMID: 32144135;
PMCID: PMC7348681.
[vi] Le
DT, et al. PD-1
blockade in tumors with mismatch repair deficiency. N Engl J Med.
2015;372(26):2509-2520.
[vii] 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.
[viii] National
Cancer Institute at the National Institutes of Health. Definition
of mismatch repair deficiency. Available at:
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mismatch-repair-deficiency.
Accessed May 5, 2021.
[ix] 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.
[x] 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.
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
February 10, 2023
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GSK plc
|
GSK (NYSE:GSK)
Historical Stock Chart
From Jun 2024 to Jul 2024
GSK (NYSE:GSK)
Historical Stock Chart
From Jul 2023 to Jul 2024