REG - GSK PLC - EMA file accepted for momelotinib

GSKAnnouncement

02/12/2022 07:00

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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  (#_edn1)
(, ii  (#_edn2) , iii  (#_edn3) , iv  (#_edn4) ) 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  (#_edn5) ) Patients
will often require transfusions, and more than 30% will discontinue treatment
due to anaemia. vi  (#_edn6) Anaemia and transfusion dependence strongly
correlate with poor prognosis and shortened survival. vii  (#_edn7)

 

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
(https://www.gsk.com/en-gb/company/) .

 

 

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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 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  (#_ednref1) 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  (#_ednref2) 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  (#_ednref3) 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  (#_ednref4) 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  (#_ednref5) 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  (#_ednref6) 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  (#_ednref7) 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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