TIDMGSK
RNS Number : 1363H
GSK PLC
22 November 2022
Issued: 22 November 2022, London UK
GSK provides an update on Blenrep (belantamab mafodotin-blmf) US
marketing authorisation
GSK plc (LSE/NYSE: GSK) today announced it has initiated the
process for withdrawal of the US marketing authorisation for
Blenrep (belantamab mafodotin-blmf) following the request of the US
Food and Drug Administration (FDA). This request was based on the
previously announced outcome of the DREAMM-3 phase III confirmatory
trial, which did not meet the requirements of the US FDA
Accelerated Approval regulations. Blenrep is a monotherapy
treatment for adult patients with relapsed or refractory multiple
myeloma (RRMM) who have received at least four prior therapies,
including an anti-CD38 monoclonal antibody, a proteasome inhibitor,
and an immunomodulatory agent.
As part of the Company's efforts to ensure physicians and
patients are supported during this important time, p atients
already enrolled in the Blenrep Risk Evaluation and Mitigation
Strategy (REMS) programme will have the option to enrol in a
compassionate use programme to continue to access treatment.
Further information on enrolling patients into the compassionate
use programme will be provided directly to REMS-enrolled
prescribers. Pa tients currently being treated with Blenrep should
consult their healthcare provider.
GSK continues to believe, based on the totality of data
available from the DREAMM (DRiving Excellence in Approaches to
Multiple Myeloma) development programme, that the benefit-risk
profile of belantamab mafodotin-blmf remains favourable in this
hard-to-treat RRMM patient population. Patients responding to
belantamab mafodotin-blmf experienced durable clinical benefit, and
safety remains consistent with the known safety profile.
Sabine Luik, Chief Medical Officer, said, "We respect the
Agency's approach to the accelerated approval regulations and
associated process. Multiple myeloma is a challenging disease, with
poor outcomes for patients whose disease has become resistant to
standard-of-care treatments. We will continue the DREAMM clinical
trial programme and work with the US FDA on a path forward for this
important treatment option for patients with multiple myeloma."
Additional trials within the DREAMM clinical trial programme are
designed to determine the benefit of belantamab mafodotin-blmf in
combination treatment with novel therapies and standard-of-care
treatments in earlier lines of therapy and dosing optimisation to
maintain efficacy while reducing corneal events. Data from the
DREAMM-7 and DREAMM-8 phase III trials are event-driven, and
results are anticipated in the first half of 2023. The results of
these trials will be shared with health authorities and inform
future regulatory pathways.
About DREAMM-3
The DREAMM-3 phase III trial is an open-label, randomised
head-to-head superiority trial evaluating the efficacy and safety
of single-agent belantamab mafodotin compared to pomalidomide in
combination with low-dose dexamethasone ( PomDex) in patients with
RRMM. A total of 325 participants were randomised in a 2:1 ratio to
receive either single-agent belantamab mafodotin administered as a
2.5 mg/kg dose every three weeks or PomDex. Pomalidomide was
administered daily on days 1 to 21 of each 28-day cycle, with
dexamethasone administered once weekly (days 1, 8, 15, and 22 of
each cycle). The primary endpoint was PFS. Secondary endpoints
include overall survival, safety, ORR, duration of response and
assessment of minimal residual disease.
About DREAMM-7
DREAMM-7 is evaluating the safety and efficacy of belantamab
mafodotin in combination with bortezomib and dexamethasone versus
daratumumab in combination with bortezomib and dexamethasone.
About DREAMM-8
DREAMM-8 is assessing the efficacy and safety of belantamab
mafodotin in combination with pomalidomide and dexamethasone
compared with that of a combination of pomalidomide, bortezomib and
dexamethasone in participants with relapsed/refractory multiple
myeloma.
About multiple myeloma
Multiple myeloma is the second most common blood cancer in the
US and is generally considered treatable but not curable. ([1]) (,
[2]) In the US, more than 32,000 people are estimated to be
diagnosed with multiple myeloma this year, and nearly 13,000 people
will die from the disease. ([3]) Research into new therapies is
needed as multiple myeloma commonly becomes refractory to available
treatments. ([4])
About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival
by transduction of signals from two known ligands, BAFF (B-cell
activating factor) and APRIL (a proliferation-inducing ligand).
This pathway is important for myeloma cell growth and survival.
BCMA expression is limited to B cells at later stages of
development. BCMA is expressed at varying levels in myeloma
patients, and BCMA membrane expression is universally detected in
myeloma cell lines. [5]
About Blenrep
Blenrep is an antibody-drug conjugate comprising a humanised
BCMA 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 Prescribing Information for a full list of
adverse events and the complete important safety information in the
US.
GSK in oncology
GSK is focused on maximising patient survival through
transformational medicines. GSK's pipeline is focused on
immuno-oncology, 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,
and antibody-drug conjugates, 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 .
GSK enquiries
Media: Tim Foley +44 (0) 20 8047 (London)
5502
Madeleine Breckon +44 (0) 20 8047 (London)
5502
Kathleen Quinn +1 202 603 5003 (Washington DC)
Lyndsay Meyer +1 202 302 4595 (Washington DC)
Investor Relations: Nick Stone +44 (0) 7717 618834 (London)
James Dodwell +44 (0) 20 8047 (London)
2406
Mick Readey +44 (0) 7990 339653 (London)
Josh Williams +44 (0) 7385 415719 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
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 Q3 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
[1] CA: A Cancer Journal for Clinicians, Vol. 70, Issue 1,
Han/Feb 2020 Pages 7-30.
[2] 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.
[3] SEER Cancer Facts & Figures 2019. Available at:
https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed October
2021.
[4] Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for
relapsed and refractory multiple myeloma. Blood. 2015;125(20).
[5] Lonial, S, et al. Belantamab mafodotin for relapsed or
refractory multiple myeloma (DREAMM-2): a two-arm, randomised,
open-label, phase 2 study. Lancet Oncol. 2020; 21(2):207-21.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
UPDXFLLLLFLBFBB
(END) Dow Jones Newswires
November 22, 2022 02:00 ET (07:00 GMT)
Gsk (LSE:GSK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gsk (LSE:GSK)
Historical Stock Chart
From Apr 2023 to Apr 2024
