REG - GSK PLC - Blenrep EMA Filing Acceptance

GSKAnnouncement

19/07/2024 10:45

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RNS Number : 0213X  GSK PLC  19 July 2024

Issued: 19 July 2024, London UK

 

Blenrep (belantamab mafodotin) combinations in multiple myeloma application
accepted for review by the European Medicines Agency

 

 ●    Regulatory submission supported by phase III head-to-head DREAMM-7 and
      DREAMM-8 trials

 ●    Trials showed significant progression-free survival benefit and positive
      overall survival trends for Blenrep combinations versus standard of care

 ●    If approved, Blenrep plus BorDex or PomDex could redefine the
      relapsed/refractory multiple myeloma treatment landscape

 

 

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency
(EMA) has accepted the marketing authorisation application (MAA) for Blenrep
(belantamab mafodotin) in combination with bortezomib plus dexamethasone
(BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for
relapsed or refractory multiple myeloma. The EMAÕs Committee for Medicinal
Products for Human Use (CHMP) will begin the formal review process to make a
recommendation to the European Commission regarding this potential
authorisation.

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: ÒTodayÕs milestone reinforces the potential for Blenrep to redefine
outcomes for patients with multiple myeloma at or after first relapse. We are
working to bring Blenrep to patients as quickly as possible given the high
unmet need and the clinically robust effects of the Blenrep combinations in
the DREAMM-7 and DREAMM-8 phase III head-to-head trials.Ó

 

The application is based on interim results from the DREAMM-7 and DREAMM-8
phase III trials, which both met their primary endpoints, showing
statistically significant and clinically meaningful improvements in
progression-free survival (PFS) for the belantamab mafodotin combinations
compared to standard of care combinations in relapsed or refractory multiple
myeloma. The DREAMM-7 trial is evaluating belantamab mafodotin combined with
BorDex versus daratumumab plus BorDex, while the DREAMM-8 trial is evaluating
belantamab mafodotin in combination with PomDex versus bortezomib plus PomDex.

 

A positive overall survival (OS) trend was observed in both trials but was not
statistically significant at the time of interim analysis. Follow-up for OS
continues. Results also showed clinically meaningful improvements across all
other secondary efficacy endpoints, including deeper and more durable
responses compared to the respective standard of care combinations. The safety
and tolerability profiles of the belantamab mafodotin combinations in DREAMM-7
and DREAMM-8 trials were broadly consistent with the known profiles of the
individual agents.

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable. 1  (#_edn1) (, 2  (#_edn2) )
There are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year, including approximately 50,000 new cases in
Europe. 3  (#_edn3) (, 4  (#_edn4) ) Research into new therapies is needed as
multiple myeloma commonly becomes refractory to available treatments. 5 
(#_edn5)

 

About DREAMM-7

The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised
trial evaluating the efficacy and safety of belantamab mafodotin in
combination with BorDex compared to a combination of daratumumab and BorDex in
patients with relapsed/refractory multiple myeloma who previously were treated
with at least one prior line of multiple myeloma therapy, with documented
disease progression during or after their most recent therapy.

 

A total of 494 participants were randomised at a 1:1 ratio to receive either
belantamab mafodotin in combination with BorDex or a combination of
daratumumab and BorDex. Belantamab mafodotin was scheduled to be dosed at
2.5mg/kg intravenously every three weeks.

 

The primary endpoint is PFS as per an independent review committee. The key
secondary endpoints include OS, duration of response (DOR), and minimal
residual disease (MRD) negativity rate as assessed by next-generation
sequencing. Other secondary endpoints include overall response rate (ORR),
safety and patient reported and quality of life outcomes.

 

Results from DREAMM-7 were first presented
(https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/)
 6  (#_edn6) at the American Society of Clinical Oncology (ASCO) Plenary
Series in February 2024, shared in an encore presentation at the 2024 ASCO
Annual Meeting, and published in the New England Journal of Medicine.

 

About DREAMM-8

The DREAMM-8 phase III clinical trial is a multicentre, open-label, randomised
trial evaluating the efficacy and safety of belantamab mafodotin in
combination with PomDex compared to a combination of bortezomib and PomDex in
patients with relapsed/refractory multiple myeloma previously treated with at
least one prior line of multiple myeloma therapy, including a
lenalidomide-containing regimen, and who have documented disease progression
during or after their most recent therapy. Compared to the patient population
studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily
pre-treated in that all had prior exposure to lenalidomide, 75% were
refractory to lenalidomide, 25% had prior daratumumab exposure and of those
most were daratumumab refractory.

 

A total of 302 participants were randomised at a 1:1 ratio to receive either
belantamab mafodotin plus PomDex, or bortezomib plus PomDex.

 

The primary endpoint is PFS as per an independent review committee. The key
secondary endpoints include OS and MRD negativity rate as assessed by
next-generation sequencing. Other secondary endpoints include ORR, DOR, safety
and patient reported and quality of life outcomes.

 

Results from DREAMM-8 were first presented
(https://www.gsk.com/en-gb/media/press-releases/blenrep-combination-reduced-the-risk-of-disease-progression/)
 7  (#_edn7) at the 2024 ASCO Annual Meeting and published in the New England
Journal of Medicine.

 

About Blenrep

Blenrep is an antibody-drug conjugate comprising a humanised B-cell
maturation antigen monoclonal antibody conjugated to the cytotoxic agent
auristatin F via a non-cleavable linker. The drug linker technology is
licensed from Seagen Inc.; the monoclonal antibody is produced using
POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin
Group.

 

Refer to the Blenrep UK Summary of Product Characteristics
(https://mhraproducts4853.blob.core.windows.net/docs/6f7040d4dd63fafa1f228164fce767517be4e3c6)
 8  (#_edn8)  for a full list of adverse events and the complete important
safety information in the United Kingdom.

 

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 ÒRisk factorsÓ in GSKÕs Annual Report on Form 20-F for 2023, and
GSKÕs Q1 Results for 2024.

 

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 1  (#_ednref1) Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics
2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers
in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249.
doi:10.3322/caac.21660.

 2  (#_ednref2) Kazandjian D. Multiple myeloma epidemiology and survival: A
unique malignancy. Semin Oncol.
2016;43(6):676Ð681.doi:10.1053/j.seminoncol.2016.11.004.

 3  (#_ednref3) Global Cancer Observatory. International Agency for Research
on Cancer. World Health Organization. Multiple Myeloma fact sheet. Available
at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf.
Accessed 5 July 2024.

 4  (#_ednref4) Global Cancer Observatory. International Agency for Research
on Cancer. World Health Organization. Multiple Myeloma fact sheet. Available
at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf.
Accessed 5 July 2024.

 5  (#_ednref5) Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for
relapsed and refractory multiple myeloma. Blood. 2015;125(20).

 6  (#_ednref6) GSK press release issued 05 February 2024. DREAMM-7 phase III
trial shows Blenrep combination nearly tripled median progression-free
survival versus standard of care combination in patients with
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/

 7  (#_ednref7) GSK press release issued 02 June 2024. Blenrep combination
reduced the risk of disease progression or death by nearly 50% versus standard
of care combination in relapsed/refractory multiple myeloma Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-combination-reduced-the-risk-of-disease-progression/

 8  (#_ednref8) Blenrep UK Summary of Product Characteristics. Available
at: https://mhraproducts4853.blob.core.windows.net/docs/6f7040d4dd63fafa1f228164fce767517be4e3c6
(https://mhraproducts4853.blob.core.windows.net/docs/6f7040d4dd63fafa1f228164fce767517be4e3c6)
.

 

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