a2099t
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 November 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:
13 November 2023, London UK
GSK receives positive CHMP opinion recommending momelotinib for
myelofibrosis patients with anaemia
●
If approved, momelotinib will become
the first and only treatment in the EU specifically indicated for
myelofibrosis patients with moderate to severe
anaemia
●
Decision
on EU marketing authorisation expected for momelotinib by early
2024
GSK plc
(LSE/NYSE: GSK) today announced the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a positive opinion recommending approval of
momelotinib 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.
The CHMP opinion is one of the final steps prior to a marketing
authorisation decision by the European Commission. If
approved, momelotinib would be the only medicine in the
European Union (EU) specifically indicated for both newly diagnosed and previously
treated myelofibrosis patients with moderate to severe
anaemia that addresses splenomegaly and
symptoms.
Nina Mojas, Senior Vice President, Oncology Global Product
Strategy, GSK, said: "Momelotinib has a differentiated mechanism of
action that may address the significant medical needs of
myelofibrosis patients, especially those with moderate to severe
anaemia. The vast majority of myelofibrosis patients will develop
anaemia, causing them to require transfusions and leading a notable
proportion to discontinue treatment. This positive CHMP opinion is
a significant step in bringing momelotinib to patients in the EU
with this difficult-to-treat blood cancer."
The
positive CHMP opinion is supported by data from the pivotal
MOMENTUM study and a subpopulation of adult patients with moderate to
severe anaemia (haemoglobin <10
g/dL) from the SIMPLIFY-1 phase III
trial.[1],2 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.1,[2]
If approved in the EU, momelotinib will be available under the
proposed trade name Omjjara. This opinion follows the September 2023 approval
(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/)
of momelotinib under the brand name Ojjaara by the US Food and Drug Administration (FDA) 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. Momelotinib is not approved in any other
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).1,[3],[4],[5] Inhibition of JAK1 and JAK2 may improve
constitutional symptoms and splenomegaly.1,3,5 Additionally, inhibition of ACVR1 leads to a
decrease in circulating hepcidin levels, potentially contributing
to anaemia benefit.1,3,4,5
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.[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.[7],[8],[9],[10] Myelofibrosis
patients with anaemia require additional supportive care, including
transfusions, and more than 30% will discontinue treatment due to
anaemia.[11] Patients who
are transfusion dependent have a poor prognosis and shortened
survival.3,[12],[13],[14],[15],[16],[17],[18],[19]
About the pivotal clinical trials
MOMENTUM was a phase III, global, multicentre, randomised,
double-blind study investigating momelotinib versus danazol in patients with myelofibrosis who
were symptomatic and anaemic and had been previously treated with
an 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. The MOMENTUM trial met all its primary
and key secondary endpoints, demonstrating statistically
significant response with respect to constitutional symptoms,
splenic response and transfusion independence, in patients treated
with momelotinib versus danazol.[20] 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
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02036-0/fulltext),[21],[22] 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
(https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(23)00174-6/fulltext).[23],[24]
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. Safety and efficacy results
for SIMPLIFY-1 were based upon a subset of patients 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).
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.
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 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] 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.
[2] 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.
[3] Chifotides, HT, Bose, P, Verstovsek, S.
Momelotinib: an emerging treatment for myelofibrosis patients with
anemia. J Hematol
Oncol. 2022;15(7):1-18.
[4] 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.
[5] 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.
[6] 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.
[7] 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
[8] Bose P, et al. Curr Hematol Malign Rep.
2018;13:164-172. doi:
https://doi.org/10.3109/10428194.2013.813500
[9] 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
[10] 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
[11] 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.
[12] 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
[13] 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
[14] 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
[15] 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
[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] 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
[19] 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
[20] 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.
[21] Mesa R, et al. Presented at: American Society of
Clinical Oncology; June 2022. Abstract 7002.
[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] Gerds AT, et al. Presented at: American Society
of Hematology; December 2022. Abstract 627.
[24] 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: November
13, 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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