REG - GSK PLC - GSK announces positive Blenrep DREAMM-8 results

GSKAnnouncement

07/03/2024 07:00

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RNS Number : 9251F  GSK PLC  07 March 2024

Issued: 07 March 2024, London UK

 

GSK announces positive results from DREAMM-8 phase III trial for Blenrep
versus standard of care combination in relapsed/refractory multiple myeloma

 

·   Trial unblinded early at an interim analysis based on Independent Data
Monitoring Committee recommendation

·   Blenrep (belantamab mafodotin) plus PomDex showed statistically
significant and clinically meaningful progression-free survival compared to
bortezomib plus PomDex

·   Consistent efficacy results observed for Blenrep combinations in two
phase III head-to-head trials

 

GSK plc (LSE/NYSE: GSK) today announced positive headline results from an
interim analysis of the DREAMM-8 phase III head-to-head trial evaluating
Blenrep (belantamab mafodotin), in combination with pomalidomide plus
dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as
a second line and later treatment for relapsed or refractory multiple myeloma.
The trial met its primary endpoint of progression-free survival (PFS) at a
pre-specified interim analysis and was unblinded early based on the
recommendation by an Independent Data Monitoring Committee (IDMC).

The belantamab mafodotin combination significantly extended the time to
disease progression or death versus the standard of care combination. A
positive overall survival (OS) trend favouring the Blenrep combination was
also observed at the time of this analysis. The trial continues to follow up
for OS. The safety and tolerability of the belantamab mafodotin regimen were
broadly consistent with the known safety profile of the individual agents.

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "The results seen in both DREAMM-7 and DREAMM-8 provide strong clinical
evidence of the robust efficacy shown with belantamab mafodotin in use with
standard of care combinations. We now look forward to discussing these data
with regulators.  If approved, we believe these combinations have the
potential to redefine the treatment of relapsed or refractory multiple myeloma
and advance the standard of care. This is exciting news for patients given the
high unmet medical need for both efficacious and easily administered therapies
with differing mechanisms of action."

 

DREAMM-8 is the second phase III head-to-head belantamab mafodotin combination
trial in second line and later treatment for multiple myeloma to report
positive results. Positive findings from DREAMM-7, a phase III head-to-head
trial evaluating belantamab mafodotin in combination with bortezomib and
dexamethasone (BorDex) versus daratumumab plus BorDex in the same treatment
setting, were 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/)
(1) at the American Society of Clinical Oncology (ASCO) Plenary Series on 6
February 2024. Detailed findings from DREAMM-8 will be presented at a future
medical congress and shared with regulatory authorities.

 

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.

 

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. Secondary endpoints include OS, overall response
rate, duration of response, minimal residual disease negativity as assessed by
next-generation sequencing, safety, and patient-reported and quality of life
outcomes.

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable.(2,3) There are approximately
176,000 new cases of multiple myeloma diagnosed globally each year.(4)
Research into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.(5)

 

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)
(6) for a full list of adverse events and the complete important safety
information in the United Kingdom.

 

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 the company's Annual Report on Form 20-F for 2023.

 

This announcement contains inside information. The person responsible for
arranging the release of this announcement on behalf of GSK is Victoria Whyte,
Company Secretary.

Registered in England & Wales:

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References

(1) 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/.

(2) 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.

(3) 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.

(4) Multiple Myeloma: Statistics. Cancer.net. Published February 2022.
https://www.cancer.net/cancer-types/multiple-myeloma/statistics#:~:text=This%20year%2C%20an%20estimated%2034%2C470,with%20multiple%20myeloma%20in%202020.
Accessed 19 October 2023.

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

(6) Blenrep UK Summary of Product Characteristics, available at:
https://mhraproducts4853.blob.core.windows.net/docs/6f7040d4dd63fafa1f228164fce767517be4e3c6.

 

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