TIDMGSK
RNS Number : 3580I
GSK PLC
02 December 2022
Issued: 2 December 2022, London UK
European Medicines Agency accepts marketing authorisation
application for momelotinib for the treatment of myelofibrosis
-- Application includes data from key phase III trials,
including the pivotal MOMENTUM trial, which met all primary and key
secondary efficacy endpoints
GSK plc (LSE/NYSE: GSK) today announced that the European
Medicines Agency (EMA) validated the marketing authorisation
application (MAA) for momelotinib, a potential new oral treatment
for myelofibrosis. Momelotinib has a differentiated mechanism of
action, with inhibitory ability along three key signalling
pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor
type I (ACVR1), which could address the significant medical needs
of myelofibrosis patients with anaemia.
The MAA is based on results from key phase III trials, including
the pivotal MOMENTUM trial, which met all primary and key secondary
endpoints, including Total Symptom Score (TSS), Transfusion
Independence (TI) rate and Splenic Response Rate (SRR). The primary
analysis data from the MOMENTUM phase III trial were presented at
the 2022 American Society of Clinical Oncology Annual Meeting and
the European Hematology Association 2022 Hybrid Congress. Updated
48-week data will be presented at the upcoming American Society of
Hematology (ASH) Annual Meeting and Exposition on 10-13 December
2022.
A Committee for Medicinal Products for Human Use (CHMP)
regulatory action is anticipated by year-end 2023, and a New Drug
Application for momelotinib is currently under regulatory review
with the US Food and Drug Administration (FDA) with a Prescription
Drug User Fee Act action date of 16 June 2023. Momelotinib is not
currently approved in any market, but if approved by regulators,
momelotinib would be the only medicine that addresses key
manifestations of myelofibrosis, including anaemia, symptoms, and
splenomegaly.
About the pivotal MOMENTUM phase III clinical trial
MOMENTUM is a global, randomised, double-blind phase III
clinical trial of momelotinib versus danazol in patients with
myelofibrosis who were symptomatic and anaemic and had been
previously treated with a US FDA-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 (enlarged
spleen).
The trial's primary efficacy endpoint was TSS reduction of
>=50% over the 28 days immediately before the end of Week 24
compared to baseline TSS, using the Myelofibrosis Symptom
Assessment Form. Key secondary endpoints included TI rate for
>=12 weeks immediately before the end of Week 24 with
haemoglobin levels >= 8 g/dL and SRR based on splenic volume
reduction of >=35% at Week 24 from baseline.
Patients were randomised at 2:1 to receive either momelotinib or
danazol (n=130 and n=65, respectively). After 24 weeks of
treatment, patients on danazol were allowed to crossover to receive
momelotinib. Early crossover to momelotinib was available for
confirmed splenic progression. The trial enrolled 195 patients
across 21 countries.
About momelotinib
Momelotinib is a potential new medicine with a differentiated
mechanism of action, with inhibitory ability along three key
signalling pathways: Janus kinase (JAK) 1 and JAK2 and activin A
receptor type I (ACVR1). [i](, [ii] , [iii] , [iv]) Inhibition of
JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.
(i) (,) (ii) (,) (iv) Additionally, direct inhibition of ACVR1
leads to a decrease in circulating hepcidin, which is elevated in
myelofibrosis and contributes to anaemia. (i) (,) (ii) (,) (iii)
(,) (iv)
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 20,000 patients in the US, with about 40% of patients
already anaemic at the time of diagnosis and nearly all patients
estimated to develop anaemia eventually. (i) (, [v]) Patients will
often require transfusions, and more than 30% will discontinue
treatment due to anaemia. [vi] Anaemia and transfusion dependence
strongly correlate with poor prognosis and shortened survival.
[vii]
GSK in oncology
GSK is focused on maximising patient survival through
transformational medicines. GSK's pipeline is focused on
immuno-oncology, tumour cell targeting therapies and synthetic
lethality. Our goal is to achieve a sustainable flow of new
treatments based on a diversified portfolio of investigational
medicines utilising modalities such as small molecules, antibodies,
and antibody-drug conjugates, either alone or in combination.
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/company .
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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 in the Company's
Annual Report on Form 20-F for 2021, GSK's Q3 Results for 2022 and
any impacts of the COVID-19 pandemic.
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[i] Chifotides, H.T., Bose, P. & Verstovsek, S. Momelotinib:
an emerging treatment for myelofibrosis patients with
anemiaanaemia. J Hematol Oncol 15, 7 (2022).
https://doi.org/10.1186/s13045-021-01157-4
[ii] 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.
https://doi.org/10.2217/fon-2020-1048
[iii] 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.
[iv] 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.
[v] Naymagon, L., & Mascarenhas, J. (2017).
Myelofibrosis-Related Anemia: Current and Emerging Therapeutic
Strategies. HemaSphere, 1(1), e1.
https://doi.org/10.1097/HS9.0000000000000001
[vi] Palandri, F., Palumbo, G.A., Elli, E.M. et al. Ruxolitinib
discontinuation syndrome: incidence, risk factors, and management
in 251 patients with myelofibrosis. Blood Cancer J. 11, 4 (2021).
https://doi.org/10.1038/s41408-020-00392-1
[vii] Pardanani, A., & Tefferi, A. (2011). Prognostic
relevance of anemia and transfusion dependency in myelodysplastic
syndromes and primary myelofibrosis. Haematologica, 96(1), 8-10.
https://doi.org/10.3324/haematol.2010.035519
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