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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 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)
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 . . . . . . . .
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Issued: 17 August 2022, London UK
US FDA accepts New Drug Application for GSK's momelotinib for the
treatment of myelofibrosis
●
Regulatory
submission included data from the pivotal MOMENTUM phase III
clinical trial that
met all primary and key secondary efficacy
endpoints
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) accepted the New Drug Application (NDA) for
momelotinib, a potential new medicine with a proposed
differentiated mechanism of action that may address the significant
unmet medical needs of myelofibrosis patients with anaemia. The US
FDA has assigned a Prescription Drug User Fee Act action date of 16
June 2023.
The NDA is based on the 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 trial were recently
presented at the 2022 American Society of Clinical Oncology Annual
Meeting and the European Hematology Association 2022 Hybrid
Congress.
Momelotinib is not currently approved in any market.
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 an 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
Momelotinib was most recently developed by Sierra Oncology, Inc.,
which GSK acquired in July 2022, building on GSK's expertise in
haematology and portfolio of specialty medicines and
vaccines.
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, cell therapy, 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,
antibody-drug conjugates, and cell therapy, 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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Madeleine
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Investor
Relations:
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Nick
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(London)
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James
Dodwell
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Mick
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Josh
Williams
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Jeff
McLaughlin
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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 in the Company's
Annual Report on Form 20-F for 2021, GSK's Q2 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
anemia. 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: August
17, 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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