a9383l
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 September 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 . . . . . . . .
Issued: 11 September 2023, London UK
GSK regulatory submission for momelotinib for the treatment of
myelofibrosis accepted for review by Japanese
regulator
●
Regulatory
submission included data from pivotal trials addressing key
clinical manifestations of
myelofibrosis, namely splenomegaly, constitutional
symptoms and anaemia
GSK plc (LSE/NYSE: GSK) today announced that the Ministry of
Health, Labour and Welfare (MHLW), Japan, has accepted for
review a new drug
application (NDA) for momelotinib, a potential new medicine with a
differentiated mechanism of action that may address the significant
medical needs of myelofibrosis patients, especially those with
anaemia. The
NDA is based on data from
the pivotal phase III
trials SIMPLIFY-1 and MOMENTUM.
Myelofibrosis is a blood cancer that can lead to splenomegaly
(enlarged spleen); constitutional symptoms such as fatigue, night
sweats, and bone pain; and severely low blood counts, including
anaemia and thrombocytopenia.[1],[2],[3] About
70% of patients diagnosed with primary myelofibrosis and about half
of patients diagnosed with secondary myelofibrosis in Japan have
moderate to severe anaemia at the time of diagnosis, and nearly all
patients are estimated to develop anaemia over the course of the
disease.[4],[5],[6],[7],[8],[9] Patients
who are transfusion dependent have a poor prognosis and shortened
survival.[10],[11],[12],[13],[14],[15],[16],[17],[18]
Momelotinib is not currently approved in any market.
About momelotinib
Momelotinib has a differentiated mechanism of action, with
inhibitory ability along three key signalling pathways: Janus
kinase (JAK) 1, JAK2, and activin A receptor, type I
(ACVR1).[19],[20],[21],[22] Inhibition
of JAK1 and JAK2 may improve constitutional symptoms and
splenomegaly.19,21,22 Additionally,
inhibition of ACVR1 leads to a decrease in circulating hepcidin,
which is elevated in myelofibrosis and contributes to
anaemia.19,20,21,22
About myelofibrosis
Myelofibrosis is a rare blood cancer that disrupts the body's
normal production of blood cells as a result of dysregulated
JAK-signal transducer and activator of transcription protein
signalling. The clinical hallmarks of myelofibrosis are progressive
splenomegaly (enlarged spleen), anaemia and debilitating symptoms
attributable to ineffective hematopoiesis and excessive production
of proinflammatory cytokines.[23] Myelofibrosis
patients with anaemia require additional supportive care, including
transfusions, and have poor outcomes.[24],[25] Myelofibrosis affects
approximately 1 in 500,000 people worldwide, with up to 5,000
patients impacted in Japan.10,19,[26],[27]
About the pivotal SIMPLIFY-1 clinical trial
SIMPLIFY-1 was a multicentre randomised, double-blind, phase III
study that compared the safety and efficacy of momelotinib to
ruxolitinib in patients with myelofibrosis who had not received
prior treatment with a JAK inhibitor. SIMPLIFY-1
met its primary endpoint, demonstrating non-inferiority of
momelotinib to ruxolitinib in spleen
volume response (reduction by 35% or greater), and substantial
improvements in transfusion independence rates.[28],[29]
About the pivotal MOMENTUM clinical trial
MOMENTUM was a global, randomised, double-blind phase III clinical
trial of momelotinib (MMB) versus danazol (DAN) in patients with
myelofibrosis who were symptomatic and anaemic and had been
previously treated with an approved JAK
inhibitor. The
MOMENTUM trial met all its primary and key secondary endpoints,
with respect to splenic response, constitutional symptoms and
transfusion independence. Results
from the 24-week treatment period were presented at the 2022
American Society of Clinical Oncology (ASCO) Annual Meeting and
subsequently published in The
Lancet (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02036-0/fulltext).22,[30]
GSK in oncology
GSK is committed to maximising patient survival through
transformational medicines, with a current focus on breakthroughs
in immuno-oncology and tumor-cell targeting therapies, and
development in haematologic malignancies, gynaecologic cancers and
other solid tumours.
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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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 the company's Annual Report on Form 20-F for
2022, and Q2 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
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TW8
9GS
[1] NIH
National Library of Medicine. Primary Myelofibrosis. September
2014. Accessed 5 August 2022.
https://medlineplus.gov/genetics/condition/primary-myelofibrosis/
[2] MPN
Research Foundation. Primary Myelofibrosis (PMF). 2021.
Accessed August, 2022.
http://www.mpnresearchfoundation.org/primary-myelofibrosis-pmf/
[3] National
Organization for Rare Disorders (NORD). Primary Myelofibrosis.
2018. Accessed 9 August 2022.
https://rarediseases.org/rare-diseases/primary-myelofibrosis/
[4] Takenaka
K et al., Clinical features and outcomes of patients with primary
myelofibrosis in Japan: report of a 17-year nationwide survey by
the Idiopathic Disorders of Hematopoietic Organs Research Committee
of Japan. Int J
Hematol. 2017
Jan;105(1):59-69. doi:
10.1007/s12185-016-2102-3
[5] Tefferi
A, Lasho TL, Jimma T, et al. One
thousand patients with primary myelofibrosis: the mayo clinic
experience. Mayo Clin
Proc.
2012;87(1):25-33.
doi:10.1016/j.mayocp.2011.11.001
[6] Bose
P, et al. Curr Hematol
Malign Rep.
2018;13:164-172. doi:
https://doi.org/10.3109/10428194.2013.813500
[7] Scherber,
R.M., Mesa, R. Management of challenging myelofibrosis after JAK
inhibitor failure and/or progression. Blood
Rev.
2020;42:100716.
https://doi.org/10.1016/j.blre.2020.100716
[8] Bassiony
S, Harrison CN, McLornan DP. Evaluating the Safety, Efficacy, and
Therapeutic Potential of Momelotinib in the Treatment of
Intermediate/High-Risk Myelofibrosis: Evidence to
Date. Ther Clin
Risk Manag.
2020;16:889-901. Published 2020 Sep 25.
doi:10.2147/TCRM.S258704
[9] Shide
K et al. Nationwide
prospective survey of secondary myelofibrosis in Japan: superiority
of DIPSS-plus to MYSEC-PM as a survival risk
model. Blood Cancer
J.
2023;13(1):110. doi: 10.1038/s41408-023-00869-9
[10] Naymagon,
L., Mascarenhas, J. Myelofibrosis-Related Anemia: Current and
Emerging Therapeutic Strategies. HemaSphere.
2017;1(1):e1. doi: 10.1097/HS9.0000000000000001
[11] How
J, Hobbs GS. A Practical Guide for Using Myelofibrosis Prognostic
Models in the Clinic. J
Natl Compr Canc Netw. 2020;18(9):1271-1278.
https://doi.org/10.6004/jnccn.2020.7557
[12] Nicolosi
M, et al. Sex
and degree of severity influence the prognostic impact of anemia in
primary myelofibrosis: analysis based on 1109 consecutive
patients. Leukemia.
2018;32(5):1254-1258.
https://doi.org/10.1038/s41375-018-0028-x
[13] Tefferi
A, et al. Use
of the Functional Assessment of Cancer Therapy--anemia in persons
with myeloproliferative neoplasm-associated myelofibrosis and
anemia. Clin
Ther.
2014;36(4):560-566.
https://doi.org/10.1016/j.clinthera.2014.02.016
[14] Tefferi
A. Primary myelofibrosis: 2021 update on diagnosis,
risk-stratification and management. Am
J Hematol.
2021;96(1):145-162.
https://doi.org/10.1002/ajh.26050
[15] Rumi
E, et al. The
Genetic Basis of Primary Myelofibrosis and Its Clinical
Relevance. Int J Mol
Sci.
2020;21(23):8885.
https://doi.org/10.3390/ijms21238885
[16] QxMD.
DIPSS prognosis in myelofibrosis. Accessed September 12, 2022.
https://qxmd.com/calculate/calculator_187/dipss-prognosis-in-myelofibrosis.
[17] QxMD.
DIPSS plus score for prognosis of myelofibrosis. Accessed September
12, 2022.
[18] Elena
C, et al. Red blood cell transfusion-dependency implies a poor
survival in primary myelofibrosis irrespective of IPSS and
DIPSS. Haematologica.
2011;96(1):167-170.
https://doi.org/10.3324/haematol.2010.031831
[19] Chifotides,
HT, Bose, P, Verstovsek, S. Momelotinib: an emerging treatment for
myelofibrosis patients with anemia. J Hematol
Oncol.
2022;15(7):1-18.
[20] 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.
[21] 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.
[22] Verstovsek
S, et al. Momelotinib versus danazol in symptomatic patients with
anaemia and myelofibrosis (MOMENTUM): results from an
international, double-blind, randomised, controlled, phase 3
study. The
Lancet.
2023;401(10373):269-280.
[23] Atallah
E, Verstovsek S. Emerging drugs for
myelofibrosis. Expert
Opin Emerg Drugs. 2012 Dec;17(4):555-70. doi:
10.1517/14728214.2012.748748. PMID: 23186315; PMCID:
PMC5009610.
[24] 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
[25] Naymagon
L, Mascarenhas J. Myelofibrosis-Related Anemia: Current and
Emerging Therapeutic Strategies. Hemasphere.
2017 Dec 20;1(1):e1. doi: 10.1097/HS9.0000000000000001. PMID:
31723730; PMCID: PMC6745971.
[26] Data
on file. Sierra Oncology. 2021.
[27] Myelofibrosis
- Epidemiology Forecast - 2032. DelveInsight.
2022;1-60.
[28] Mesa
R, et al. Presented
at: ISPOR 2021.
[29] Mesa
R, et al. Presented at: SOHO 2021. Poster
MPN-303.
[30] Mesa
R, et al. Presented at: American Society of Clinical Oncology; June
2022. Abstract 7002.
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: September
11, 2023
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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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