a7255m
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: 15 September 2023, London UK
Ojjaara (momelotinib) approved in the
US as the first and only treatment indicated for myelofibrosis
patients with anaemia
●
Approval is for use in myelofibrosis patients
with anaemia regardless of prior myelofibrosis
therapy
●
Nearly all myelofibrosis
patients are estimated to develop anaemia over the course of the
disease, and over 30% will discontinue treatment due to
anaemia[1],[2],[3]
●
Ojjaara addresses key manifestations of myelofibrosis,
namely anaemia, constitutional symptoms and
splenomegaly
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Ojjaara (momelotinib) 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. Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A
receptor type 1 (ACVR1) inhibitor. To date, it
is the
only approved medicine for both newly diagnosed and previously
treated myelofibrosis patients with anaemia that addresses the key manifestations of the
disease, namely anaemia, constitutional symptoms, and splenomegaly
(enlarged spleen).[4]
Nina Mojas, Senior Vice President, Oncology Global Product
Strategy, GSK, said: "The vast majority of myelofibrosis patients
eventually develop anaemia, causing them to discontinue treatments
and require transfusions. Given this high unmet need, we are proud
to add Ojjaara to our oncology portfolio and address a
significant medical need in the community. We look forward to
helping improve outcomes in this difficult-to-treat blood
cancer."
Myelofibrosis is a blood cancer affecting approximately 25,000 patients in the
US.4,[5],[6] Myelofibrosis can lead to severely low
blood counts, including anaemia and thrombocytopaenia;
constitutional symptoms such as fatigue, night sweats, and bone
pain; and splenomegaly. 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] Physicians have had limited treatment
options to treat myelofibrosis patients with anaemia. These
patients often require transfusions and more than 30% will
discontinue treatment due to anaemia.3 Patients who are transfusion dependent have a
poor prognosis and shortened survival.1,[11],[12],[13],[14],[15],[16],[17],[18]
Ruben A. Mesa, MD, FACP, President and Executive Director, Atrium
Health Levine Cancer Center and Atrium Health Wake Forest Baptist
Comprehensive Cancer Center, said: "With momelotinib we have the potential to
establish a new standard of care for myelofibrosis patients with
anaemia. Addressing key manifestations of myelofibrosis,
including anaemia, constitutional symptoms and
splenomegaly, makes a significant difference in the treatment
regimen for these patients who have limited options to address
these aspects of the disease."
The FDA
approval of momelotinib is supported by data from the pivotal
MOMENTUM study and a subpopulation of adult patients with anaemia from
the SIMPLIFY-1 phase III
trial. 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. 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.2 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.1 Safety and efficacy
results for SIMPLIFY-1 were based upon a subset of patients with
anaemia.
In these clinical trials, the most common adverse reactions were
thrombocytopaenia, haemorrhage, bacterial infection, fatigue,
dizziness, diarrhoea, and nausea.[19]
Kapila Viges, Chief Executive Officer, MPN (Myeloproliferative
Neoplasms) Research Foundation,
said: "We are thrilled to see
momelotinib reach the clinic, giving patients and their physicians
another option to help manage myelofibrosis. Any new treatment that
takes steps toward unlocking the mysteries of this complex and
chronic blood cancer represents great progress for the
field."
Momelotinib
is currently not approved in any other market.
About Ojjaara (momelotinib)
Ojjaara 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).2,6,[20],[21] Inhibition
of JAK1 and JAK2 may improve constitutional symptoms and
splenomegaly.2,6,22 Additionally, inhibition of ACVR1 leads to a
decrease in circulating hepcidin, which is elevated in
myelofibrosis and contributes to anaemia.2,6,21,22
Please see accompanying US Prescribing Information
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Ojjaara/pdf/OJJAARA-PI-PIL.PDF).
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 25,000 patients in the
US.1,5,6
About the pivotal MOMENTUM clinical trial
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.2 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],[23]
About the 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. Safety and efficacy results
for SIMPLIFY-1 were based upon a subset of patients with anaemia
(haemoglobin <10 g/dL) at baseline. The efficacy of momelotinib in the
treatment of patients with myelofibrosis in SIMPLIFY-1 was based on
spleen volume response (reduction 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 Q2 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered
in England & Wales:
No.
3888792
Registered
Office:
980 Great West
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Brentford,
Middlesex
TW8
9GS
[1] Naymagon, L, Mascarenhas, J.
Myelofibrosis-Related Anemia: Current and Emerging Therapeutic
Strategies. HemaSphere. 2017;1(1):e1.
[2] 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.
[3] 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.
[4] Harrison C, et al. Presented at: European Hematology Association;
June 2022. Poster EP1113.
[5] Data on file. Sierra Oncology.
2021.
[6] Chifotides, HT, Bose, P, Verstovsek, S.
Momelotinib: an emerging treatment for myelofibrosis patients with
anemia. J Hematol
Oncol. 2022;15(7):1-18.
[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] 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
[12] 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
[13] 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
[14] 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
[15] QxMD. DIPSS prognosis in myelofibrosis. Accessed
September 12, 2022.
https://qxmd.com/calculate/calculator_187/dipss-prognosis-in-myelofibrosis.
[16] QxMD. DIPSS plus score for prognosis of
myelofibrosis. Accessed September 12, 2022.
[17] 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
[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] 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.
[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] 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.
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
18, 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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