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
presented1
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
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.
GSK
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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.
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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.