TIDMGSK
RNS Number : 2395W
GSK PLC
17 August 2022
Issued: 17 August 2022, London UK
US FDA accepts New Drug Application for GSK's momelotinib for
the treatment of myelofibrosis
-- Regulatory submission included data from the pivotal MOMENTUM
phase III clinical trial that met all primary and key secondary
efficacy endpoints
GSK plc (LSE/NYSE: GSK) today announced that the US Food and
Drug Administration (FDA) accepted the New Drug Application (NDA)
for momelotinib, a potential new medicine with a proposed
differentiated mechanism of action that may address the significant
unmet medical needs of myelofibrosis patients with anaemia. The US
FDA has assigned a Prescription Drug User Fee Act action date of 16
June 2023.
The NDA is based on the 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 trial were recently
presented at the 2022 American Society of Clinical Oncology Annual
Meeting and the European Hematology Association 2022 Hybrid
Congress.
Momelotinib is not currently approved in any market.
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 an 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)
Momelotinib was most recently developed by Sierra Oncology,
Inc., which GSK acquired in July 2022, building on GSK's expertise
in haematology and portfolio of specialty medicines and
vaccines.
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, cell therapy, 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,
antibody-drug conjugates, and cell therapy, 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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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 Q2 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 anemia. 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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