TIDMGSK
RNS Number : 1607T
GSK PLC
13 November 2023
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.
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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.
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[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
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