REG - GSK PLC - Blenrep US Update

GSKAnnouncement

22/11/2022 07:01

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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
(https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-dreamm-3-phase-iii-trial-for-blenrep/)
(https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-dreamm-3-phase-iii-trial-for-blenrep/)
outcome of the DREAMM-3
(https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-dreamm-3-phase-iii-trial-for-blenrep/)
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, patients 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. Patients 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  (#_edn1) ))(,( 2 
(#_edn2) )) 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  (#_edn3) )) Research into new therapies is needed as multiple
myeloma commonly becomes refractory to available treatments.(( 4  (#_edn4) ))

 

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  (#_edn5)

 

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
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blenrep/pdf/BLENREP-PI-MG.PDF)
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
(https://www.gsk.com/en-gb/about-us/) .

 

 

 GSK enquiries
 Media:               Tim Foley          +44 (0) 20 8047 5502  (London)
                      Madeleine Breckon  +44 (0) 20 8047 5502  (London)
                      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 2406  (London)
                      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:

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TW8 9GS

 1  (#_ednref1) CA: A Cancer Journal for Clinicians, Vol. 70, Issue 1, Han/Feb
2020 Pages 7-30.

 2  (#_ednref2) 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  (#_ednref3) SEER Cancer Facts & Figures 2019. Available at:
https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed October 2021.

 4  (#_ednref4) Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for
relapsed and refractory multiple myeloma. Blood. 2015;125(20).

 5  (#_ednref5) 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.

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