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 January 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:
29 January 2024, London UK
European Commission authorises GSK's Omjjara (momelotinib)
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Omjjara is the first medicine in the EU specifically
indicated for treating splenomegaly (enlarged spleen) or
symptoms in adult myelofibrosis patients with moderate to severe
anaemia
●
Authorisation may address high unmet need, with
nearly all myelofibrosis patients estimated to develop
anaemia over the course of the disease1,2,3,4
●
Indicated in both
newly diagnosed patients and those previously treated
with existing standard of care
GSK plc
(LSE/NYSE: GSK) today announced the European Commission* granted
marketing authorisation for Omjjara (momelotinib), a
once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1)
inhibitor. Omjjara is the first authorised
medicine in the EU for disease-related splenomegaly (enlarged
spleen) or symptoms in adult patients with moderate to severe
anaemia who have primary myelofibrosis, post polycythaemia vera
myelofibrosis or post essential thrombocythaemia myelofibrosis and
who are Janus kinase (JAK) inhibitor naïve or have been
treated with ruxolitinib.
Nina Mojas, Senior Vice President, Oncology Global Product
Strategy, GSK, said: "The challenges of living with myelofibrosis can
be burdensome, and symptomatic patients can experience spleen
enlargement, fatigue, night sweats and bone pain. Until now, there
have been no options specifically indicated to treat these symptoms
in patients who also experience anaemia. The authorisation
of Omjjara brings a new treatment option with a
differentiated mechanism of action to these patients in the
EU."
Myelofibrosis is estimated to affect 1 in 10,000 people in the
EU.5,6 About
40% of patients 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.1,2,3,4 Myelofibrosis patients with anaemia require
additional supportive care, including transfusions, and more than
30% will discontinue treatment due to anaemia.7 Patients
who are transfusion dependent have a poor prognosis and shortened
survival.8,9,10,11,12,13,14,15,16
Francesca Palandri, MD, PhD, IRCCS S. Orsola-Malpighi, Bologna
University Hospital, Italy, said: "The EU authorisation of Omjjara represents a meaningful advancement for
eligible patients with myelofibrosis, and particularly for those
with moderate to severe anaemia who need new treatment options that
may reduce their disease-related burden. The availability of a
single therapy for key manifestations of myelofibrosis is a clear
step forward for eligible patients."
The
authorisation of momelotinib is based on the MOMENTUM pivotal phase
III trial and a subpopulation of adult patients with moderate to
severe anaemia (haemoglobin <10 g/dL) from the SIMPLIFY-1 phase
III trial.17,18 MOMENTUM
was designed to evaluate the safety and efficacy of momelotinib
versus danazol for the treatment and reduction of key
manifestations of myelofibrosis in an anaemic, symptomatic, JAK
inhibitor-experienced population. SIMPLIFY-1 was designed to
evaluate the efficacy and safety of momelotinib versus ruxolitinib
in myelofibrosis patients who had not received a prior
JAK-inhibitor therapy.
In
these clinical trials, the most common adverse reactions were
diarrhoea, thrombocytopaenia, nausea, headache, dizziness, fatigue,
asthenia, abdominal pain, and cough.17,18
About Omjjara (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).8,17,19,20 Inhibition of JAK1 and JAK2 may improve
constitutional symptoms and splenomegaly.8,17,20 Additionally, inhibition of ACVR1 leads to a
decrease in circulating hepcidin levels, potentially contributing
to anaemia-related benefit.8,17,19,20
In
September 2023, the US Food and Drug Administration licensed
(https://www.gsk.com/en-gb/media/press-releases/ojjaara-momelotinib-approved-in-the-us-as-the-first-and-only-treatment-indicated-for-myelofibrosis-patients-with-anaemia/)
momelotinib under the brand name Ojjaara for the treatment of
intermediate or high-risk myelofibrosis, including primary
myelofibrosis or secondary myelofibrosis (post-polycythaemia vera
and post-essential thrombocythaemia), in adults with
anaemia.
Important Information for Omjjara in the EU
Indication
Omjjara is indicated for the treatment of disease-related
splenomegaly (enlarged spleen) or symptoms in adult patients with
moderate to severe anaemia who have primary myelofibrosis, post
polycythaemia vera myelofibrosis or post essential thrombocythaemia
myelofibrosis and who are Janus kinase (JAK) inhibitor naïve
or have been treated with ruxolitinib.
Refer to the Omjjara EMA Reference Information
(https://www.ema.europa.eu/en/medicines/human/EPAR/omjjara)
for a full list of adverse events and the complete important safety
information in the EU.
About myelofibrosis
Myelofibrosis
is a rare blood cancer that disrupts the body's normal production
of blood cells because of dysregulated JAK-signal transducer and
activator of transcription protein signalling. The clinical
hallmarks of myelofibrosis are splenomegaly (enlarged spleen),
progressive anaemia and debilitating constitutional symptoms, such
as fatigue, night sweats and bone pain, attributable to ineffective
haematopoiesis and excessive production of proinflammatory
cytokines.21
About the pivotal clinical trials
MOMENTUM was a phase III, global, multicentre, randomised,
double-blind study investigating momelotinib versus danazol in
patients (n=195) with myelofibrosis who were symptomatic and
anaemic and had been previously treated with a licensed 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. The MOMENTUM trial met all its primary and key
secondary endpoints, demonstrating statistically significant
response with respect to constitutional symptoms, splenic reduction
and transfusion independence in patients treated with momelotinib
versus danazol (Total Symptom Score reduction of 50% or greater:
25% momelotinib, 9% danazol, p = 0.0095; reduction of spleen volume
by 35% or greater: momelotinib 22%, danazol 3%, p = 0.0011; no
transfusions and all haemoglobin values ≥8 g/dL in the 12
weeks prior to week 24: momelotinib 30%, danazol
20%).17 Results from the 24-week randomised treatment
period were presented at the 2022 American Society of Clinical
Oncology (ASCO) Annual Meeting and subsequently published
in The Lancet,22,23 with
48-week data presented at the 64th American Society of Hematology
(ASH) Annual Meeting and Exposition in December 2022 and
subsequently published in The Lancet.24,25
SIMPLIFY-1
was a multicentre, randomised, double-blind, phase III study that
compared the safety and efficacy of momelotinib to ruxolitinib in
patients (n=432) with myelofibrosis who had not received prior
treatment with a JAK inhibitor. Safety and efficacy results for
SIMPLIFY-1 were based upon a subset of patients (n=181) with
anaemia at baseline. The efficacy of momelotinib in the treatment
of patients with myelofibrosis in SIMPLIFY-1 was based on spleen
volume response (reduction of spleen volume by 35% or greater: 31%
momelotinib, 33% ruxolitinib p = 0.026).18
GSK in oncology
GSK is
committed to maximising patient survival through transformational
medicines, with a current focus on breakthroughs in immuno-oncology
and tumour-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.
* The
European Commission has the authority to authorise medicines for
European Union member states, as well as in the European Economic
Area (EEA) countries Iceland, Norway and Liechtenstein, and
Northern Ireland.
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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 Q3 Results for 2023.
Registered
in England & Wales:
No.
3888792
Registered
Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[1] 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
[2] Bose P, et al. Curr Hematol Malign
Rep. 2018;13:164-172. doi:
https://doi.org/10.3109/10428194.2013.813500
[3] Scherber, RM, 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
[4] 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
[5] Orphanet. Primary Myelofibrosis. 2019. Accessed
01 February 2023. https://www.orpha.net
[6] Junker, S, et al. "PB2203: INCIDENCE AND
PREVALENCE OF MYELOFIBROSIS IN GERMANY: A RETROSPECTIVE CLAIMS DATA
ANALYSIS." HemaSphere 7.S3 (2023): e32222e6.
[7] Kuykendall AT, Shah S, Talati C, et al. Between a
rux and a hard place: evaluating salvage treatment and outcomes in
myelofibrosis after ruxolitinib
discontinuation. Ann
Hematol.
2018;97(3):435-441.
[8] Chifotides, HT, Bose, P, Verstovsek, S.
Momelotinib: an emerging treatment for myelofibrosis patients with
anemia. J Hematol
Oncol.
2022;15(7):1-18.
[9] 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
[10] 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
[11] 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
[12] 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
[13] QxMD. DIPSS prognosis in myelofibrosis. Accessed
September 12, 2022.
https://qxmd.com/calculate/calculator_187/dipss-prognosis-in-myelofibrosis.
[14] QxMD. DIPSS plus score for prognosis of
myelofibrosis. Accessed September 12, 2022.
[15] 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
[16] 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
[17] 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.
[18] Mesa RA, Kiladjian JJ, Catalano JV, et al.
SIMPLIFY-1: A Phase III Randomized Trial of Momelotinib Versus
Ruxolitinib in Janus Kinase Inhibitor-Naïve Patients With
Myelofibrosis. J Clin
Oncol.
2017;35(34):3844-3850.
[19] 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.
[20] 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.
[21] 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.
[22] Mesa R, et al. Presented at: American Society of
Clinical Oncology; June 2022. Abstract 7002.
[23] 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.
[24] Gerds AT, et al. Presented at: American Society
of Hematology; December 2022. Abstract 627.
[25] Gerds AT, et al. Momelotinib versus danazol in
symptomatic patients with anaemia and myelofibrosis previously
treated with a JAK inhibitor (MOMENTUM): an updated analysis of an
international, double-blind, randomised phase 3
study. The Lancet
Haematology.
2023;10(9):E735-E746.
https://doi.org/10.1016/S2352-3026(23)00174-6
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: January
29, 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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