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)
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reports under cover of Form 20-F or Form 40-F.
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Issued: 2 December 2022, London UK
European Medicines Agency accepts marketing authorisation
application for momelotinib for the treatment of
myelofibrosis
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines
Agency (EMA) validated the marketing authorisation application
(MAA) for momelotinib, a potential new oral treatment for
myelofibrosis. Momelotinib has a differentiated mechanism of
action, with inhibitory ability along three key signalling
pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor
type I (ACVR1), which could address the significant medical needs
of myelofibrosis patients with anaemia.
The MAA is based on results from key phase III trials, including
the pivotal MOMENTUM trial, which met all primary and key secondary
endpoints, including Total Symptom Score (TSS), Transfusion
Independence (TI) rate and Splenic Response Rate (SRR). The primary
analysis data from the MOMENTUM phase III trial were presented at
the 2022 American Society of Clinical Oncology Annual Meeting and
the European Hematology Association 2022 Hybrid Congress. Updated
48-week data will be presented at the upcoming American Society of
Hematology (ASH) Annual Meeting and Exposition on 10-13 December
2022.
A Committee for Medicinal Products for Human Use (CHMP) regulatory
action is anticipated by year-end 2023, and a New Drug Application
for momelotinib is currently under regulatory review with the US
Food and Drug Administration (FDA) with a Prescription Drug User
Fee Act action date of 16 June 2023. Momelotinib is not currently
approved in any market, but if approved by regulators, momelotinib
would be the only medicine that addresses key manifestations of
myelofibrosis, including anaemia, symptoms, and
splenomegaly.
About the pivotal MOMENTUM phase III clinical trial
MOMENTUM is a global, randomised, double-blind phase III clinical
trial of momelotinib versus danazol in patients with myelofibrosis
who were symptomatic and anaemic and had been previously treated
with a US FDA-approved JAK inhibitor. The trial was designed to
evaluate the safety and efficacy of momelotinib for treating and
reducing key hallmarks of the disease: symptoms, blood transfusions
(due to anaemia) and splenomegaly (enlarged spleen).
The trial's primary efficacy endpoint was TSS reduction of
≥50% over the 28 days immediately before the end of Week 24
compared to baseline TSS, using the Myelofibrosis Symptom
Assessment Form. Key secondary endpoints included TI rate for
≥12 weeks immediately before the end of Week 24 with
haemoglobin levels ≥ 8 g/dL and SRR based on splenic volume
reduction of ≥35% at Week 24 from baseline.
Patients were randomised at 2:1 to receive either momelotinib or
danazol (n=130 and n=65, respectively). After 24 weeks of
treatment, patients on danazol were allowed to crossover to receive
momelotinib. Early crossover to momelotinib was available for
confirmed splenic progression. The trial enrolled 195 patients
across 21 countries.
About momelotinib
Momelotinib is a potential new medicine with a differentiated
mechanism of action, with inhibitory ability along three key
signalling pathways: Janus kinase (JAK) 1 and JAK2 and activin A
receptor type I (ACVR1).[i],[ii],[iii],[iv] Inhibition
of JAK1 and JAK2 may improve constitutional symptoms and
splenomegaly.i,ii,iv Additionally,
direct inhibition of ACVR1 leads to a decrease in circulating
hepcidin, which is elevated in myelofibrosis and contributes to
anaemia.i,ii,iii,iv
About myelofibrosis
Myelofibrosis is a rare blood
cancer that results from dysregulated JAK-signal transducer and
activator of transcription protein signalling and is characterised
by constitutional symptoms, splenomegaly, and progressive anaemia.
Myelofibrosis affects approximately 20,000 patients in the US, with
about 40% of patients already anaemic at the time of diagnosis and
nearly all patients estimated to develop anaemia
eventually.i,[v] Patients
will often require transfusions, and more than 30% will discontinue
treatment due to anaemia.[vi] Anaemia
and transfusion dependence strongly correlate with poor prognosis
and shortened survival.[vii]
GSK in oncology
GSK is focused on 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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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] Chifotides,
H.T., Bose, P. & Verstovsek, S. Momelotinib: an emerging
treatment for myelofibrosis patients with anemiaanaemia. J Hematol
Oncol 15, 7 (2022).
https://doi.org/10.1186/s13045-021-01157-4
[ii] Verstovsek
S, et al. MOMENTUM: momelotinib vs danazol in patients with
myelofibrosis previously treated with JAKi who are symptomatic and
anemic. Future Oncol. 2021;17(12):1449-1458.
https://doi.org/10.2217/fon-2020-1048
[iii] Asshoff
M, et al. Momelotinib inhibits ACVR1/ALK2, decreases hepcidin
production, and ameliorates anemia of chronic disease in rodents.
Blood. 2017;129(13):1823-1830.
[iv] Oh
S, et al. ACVR1/JAK1/JAK2 inhibitor momelotinib reverses
transfusion dependency and suppresses hepcidin in myelofibrosis
phase 2 trial. Blood Adv. 2020;4(18):4282-4291.
[v] Naymagon,
L., & Mascarenhas, J. (2017). Myelofibrosis-Related Anemia:
Current and Emerging Therapeutic Strategies. HemaSphere, 1(1), e1.
https://doi.org/10.1097/HS9.0000000000000001
[vi] Palandri,
F., Palumbo, G.A., Elli, E.M. et al. Ruxolitinib discontinuation
syndrome: incidence, risk factors, and management in 251 patients
with myelofibrosis. Blood Cancer J. 11, 4 (2021).
https://doi.org/10.1038/s41408-020-00392-1
[vii] Pardanani,
A., & Tefferi, A. (2011). Prognostic relevance of anemia and
transfusion dependency in myelodysplastic syndromes and primary
myelofibrosis. Haematologica, 96(1), 8-10.
https://doi.org/10.3324/haematol.2010.035519
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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