REG - GSK PLC - GSK announces overall survival results for Blenrep

GSKAnnouncement

14/11/2024 07:00

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RNS Number : 1720M  GSK PLC  14 November 2024

Issued: 14 November 2024, London UK

 

Blenrep shows overall survival benefit in head-to-head DREAMM-7 phase III
trial for relapsed/refractory multiple myeloma

 

·   Statistically significant and clinically meaningful reduction in the
risk of death seen with Blenrep (belantamab mafodotin) plus bortezomib and
dexamethasone (BorDex) versus daratumumab plus BorDex

·   Full data to be presented at 2024 American Society of Hematology Annual
Meeting in December

·   Data to be shared with health authorities to support regulatory filings

 

GSK plc (LSE/NYSE: GSK) today announced positive headline results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma. The trial met the key secondary endpoint of overall survival (OS), showing that belantamab mafodotin when combined with BorDex significantly reduced the risk of death versus standard of care daratumumab plus BorDex.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "The overall survival results from the DREAMM-7 trial underscore the
potential for this Blenrep combination to extend the lives of patients with
relapsed/refractory multiple myeloma. This is a statistically significant and
clinically meaningful advancement for patients and potentially transformative
for treatment. We look forward to sharing these data with health authorities
and presenting the full results at next month's American Society of Hematology
Annual Meeting."

Results from the interim analysis, including safety data, will be presented at
the upcoming 66(th) American Society of Hematology (ASH) Annual Meeting and
Exposition on 9 December 2024 at 11:15 a.m. PT.

The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical
development programme continues to evaluate the potential of belantamab
mafodotin in early lines of treatment and in combination with novel therapies
and standard of care treatments. In addition to DREAMM-7, this includes the
ongoing head-to-head phase III DREAMM-8 trial evaluating belantamab mafodotin
in combination with pomalidomide and dexamethasone versus bortezomib in
combination with pomalidomide and dexamethasone.

 

A phase III study in newly diagnosed transplant ineligible multiple myeloma is
expected to be initiated by the end of 2024 as part of the DREAMM programme.

 

In 2024, belantamab mafodotin combinations have been filed in the US, European
Union
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-multiple-myeloma-application-accepted-for-review-by-the-european-medicines-agency/)
(( 1  (#_edn1) )), Japan
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-relapsedrefractory-multiple-myeloma-accepted-for-regulatory-review-in-japan/)
(( 2  (#_edn2) )), United Kingdom, Canada and Switzerland for the treatment of
relapsed or refractory multiple myeloma based on the results of the DREAMM-7
and DREAMM-8 trials. In China
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-in-combination-receives-breakthrough-therapy-designation-in-china-for-treatment-of-relapsedrefractory-multiple-myeloma/)
 3  (#_edn3) , the National Medical Products Administration has granted
Breakthrough Therapy Designation for belantamab mafodotin in combination with
BorDex, as well as priority review for the regulatory application based on the
results of DREAMM-7.

 

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/)
 4  (#_edn4) 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 multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable. 5  (#_edn5) (, 6  (#_edn6) )
There are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year. 7  (#_edn7) Research into new therapies is
needed as multiple myeloma commonly becomes refractory to available
treatments. 8  (#_edn8)

 

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.

 

Blenrep is approved as monotherapy in Hong Kong, Israel and Singapore. Refer
to the local Summary of Product Characteristics for a full list of adverse
events and complete important safety information.

 

GSK in oncology

Oncology is an emerging therapeutic area for GSK where we are committed to
maximising patient survival with a current focus on haematologic malignancies,
gynaecologic cancers, and other solid tumours through breakthroughs in
immuno-oncology and tumour-cell targeting therapies.

 

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 GSK's Annual Report on Form 20-F for 2023, and
GSK's Q3 Results for 2024.

 

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WC1A 1DG

 1  (#_ednref1) GSK press release issued 19 July 2024. Blenrep (belantamab
mafodotin) combinations in multiple myeloma accepted for review by the
European Medicines Agency. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-multiple-myeloma-application-accepted-for-review-by-the-european-medicines-agency/.

 2  (#_ednref2) GSK press release issued 17 September 2024. Blenrep
(belantamab mafodotin) combinations in relapsed/refractory multiple myeloma
accepted for regulatory review in Japan. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-relapsedrefractory-multiple-myeloma-accepted-for-regulatory-review-in-japan/.

 3  (#_ednref3) GSK press release issued 13 September 2024. Blenrep
(belantamab mafodotin) in combination receives Breakthrough Therapy
Designation in China for treatment of relapsed/refractory multiple myeloma.
Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-in-combination-receives-breakthrough-therapy-designation-in-china-for-treatment-of-relapsedrefractory-multiple-myeloma/.

 4  (#_ednref4) 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/.

 5  (#_ednref5) 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.

 6  (#_ednref6) Kazandjian D. Multiple myeloma epidemiology and survival: A
unique malignancy. Semin Oncol.
2016;43(6):676-681.doi:10.1053/j.seminoncol.2016.11.004.

 7  (#_ednref7) 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 12 November 2024.

 8  (#_ednref8) Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for
relapsed and refractory multiple myeloma. Blood. 2015;125(20).

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