REG - GSK PLC - Blenrep licensed by UK MHRA

GSKAnnouncement

17/04/2025 16:15

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250417:nRSQ5279Fa&default-theme=true

RNS Number : 5279F  GSK PLC  17 April 2025

Issued: 17 April 2025, London UK

 

 

Blenrep (belantamab mafodotin) combinations approved by UK MHRA in
relapsed/refractory multiple myeloma

·   Superior efficacy shown in two head-to-head phase III trials, including
overall survival in DREAMM-7

·   Blenrep combinations could redefine treatment as early as first relapse
where more effective options are needed 1  (#_edn1) (, 2  (#_edn2) , 3 
(#_edn3) )

·    UK approval first in the world with submissions under review in 14
markets and additional approvals expected in 2025

 

GSK plc (LSE/NYSE: GSK) today announced the authorisation of Blenrep by the
Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Blenrep
is approved for the treatment of adults with multiple myeloma in combination
with bortezomib plus dexamethasone (BVd) in patients who have received at
least one prior therapy, and in combination with pomalidomide plus
dexamethasone (BPd) in patients who have received at least one prior therapy
including lenalidomide. This UK regulatory authorisation marks the first in
the world for Blenrep in this treatment setting.

 

Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III
trials in relapsed or refractory multiple myeloma support MHRA authorisation
of Blenrep combinations. These include statistically significant and
clinically meaningful progression-free survival (PFS) results for Blenrep
combinations versus standards of care in both trials and overall survival (OS)
in DREAMM-7.(2)(,)(3)(, 4  (#_edn4) ) The safety and tolerability profiles of
the Blenrep combinations were broadly consistent with the known profiles of
the individual agents.(2)(,)(3)

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "Today's approval of Blenrep combinations in the UK is a transformative
milestone for patients with multiple myeloma, a cancer marked by remission and
relapse. As the only BCMA-targeted ADC therapy, Blenrep has the potential,
supported by robust phase III data, to extend survival and remission versus
standard of care and redefine treatment at or after first relapse."

 

Currently, most patients with multiple myeloma experience relapse, and in the
UK only 55% remain alive five years after diagnosis. 5  (#_edn5) Blenrep is
the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC)
in multiple myeloma, providing patients at or after relapse with a
differentiated mechanism of action. Blenrep combinations can be administered
to a range of patient types in any oncology treatment setting without complex
pre-administration regimens or hospitalisation.

 

Joseph Mikhael, MD, Chief Medical Officer, International Myeloma Foundation
and Professor, Translational Genomics Research Institute, City of Hope Cancer
Center, said: "As patients with multiple myeloma increasingly receive
combination therapies at diagnosis, treatment options available in the
community setting that use different mechanisms like Blenrep are crucial to
extending remission and ultimately survival. We are pleased to see this
advancement in the treatment landscape extended across both academic and
community settings where many patients are treated."

 

Both DREAMM-7 and DREAMM-8 showed statistically significant and clinically
meaningful PFS improvements for the Blenrep combinations compared to standard
of care triplet combinations in the second line or later treatment of multiple
myeloma.(2)(,)(3) In DREAMM-7, the Blenrep combination nearly tripled median
PFS versus the daratumumab-based comparator (36.6 months versus 13.4 months,
respectively (hazard ratio  HR : 0.41 [95% confidence interval (CI):
0.31-0.53], p-value<0.00001).(2) DREAMM-7 also met the key secondary
endpoint of OS, showing a statistically significant and clinically meaningful
42% reduction in the risk of death at a median follow-up of 39.4 months
favouring the Blenrep combination (n=243) versus the daratumumab-based
comparator (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023).(4) The three-year
OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab
combination arm. In DREAMM-8, at a median follow-up of 21.8 months, the median
PFS was not yet reached with the Blenrep combination compared to 12.7 months
in the bortezomib combination.(3)

 

Blenrep combinations consistently benefited a broad range of patients,
including those with poor prognostic features or outcomes, such as high-risk
cytogenetics or those refractory to lenalidomide. Both trials also showed
clinically meaningful improvements across all other secondary efficacy
endpoints, including deeper and more durable responses versus the respective
comparators.(2)(,)(3)

 

Eye-related side effects, a known side effect of treatment with Blenrep, were
generally resolvable, manageable with extended time between infusions and dose
reductions while maintaining efficacy, and led to low (≤9%) treatment
discontinuations in both trials.(2)(,)(3) The most commonly reported
non-ocular adverse events (>30% of participants) in the Blenrep combination
arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and
neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in the Blenrep
combination arm of DREAMM-8.

 

Blenrep combinations are currently under review in 14 countries, including in
the US
(https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations-accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple-myeloma/)
with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025, 6 
(#_edn6) 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/)
, 7  (#_edn7) Japan
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-relapsedrefractory-multiple-myeloma-accepted-for-regulatory-review-in-japan/)
(with priority review), 8  (#_edn8) China
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/)
(based on the results of DREAMM-7, with Breakthrough Therapy Designation for
the combination and priority review for the application), 9  (#_edn9) Canada,
and Switzerland (with priority review for DREAMM-8).

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable. 10  (#_edn10) (, 11  (#_edn11)
) There are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year. 12  (#_edn12)  Multiple myeloma is a
significant concern in the UK, which ranks fifth in incidence rate of all
European countries. There are approximately more than 6,500 new cases of
multiple myeloma diagnosed each year and an expected 5-year prevalence of over
19,400 cases in the UK. 13  (#_edn13) (, 14  (#_edn14) ) Research into new
therapies is needed as multiple myeloma commonly becomes refractory to
available treatments.(1) Many patients with multiple myeloma are treated in a
community cancer setting, leaving an urgent need for new, effective therapies
with manageable side effects that can be administered outside of an academic
centre. 15  (#_edn15) (, 16  (#_edn16) )

 

About Blenrep

Blenrep is an ADC 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.

 

Indication

In the UK, Blenrep is indicated in adults for the treatment of multiple
myeloma:

·      in combination with bortezomib and dexamethasone in patients who
have received at least one prior therapy; and

·      in combination with pomalidomide and dexamethasone in patients
who have received at least one prior therapy including lenalidomide.

 

IMPORTANT SAFETY INFORMATION FOR BLENREP

More information can be found in the Blenrep Summary of Product
Characteristics and Patient Information leaflets which will be published on
the MHRA Products website (https://products.mhra.gov.uk/) within 7 days of
approval.

 

About DREAMM-7

DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial
evaluating the efficacy and safety of belantamab mafodotin combined with
bortezomib plus dexamethasone (BVd) compared to daratumumab combined with
bortezomib plus dexamethasone (DVd) 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. The trial enrolled 494 participants who were
randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was
administered at a dose of 2.5mg/kg intravenously every three weeks. The
primary endpoint was PFS as per an independent review committee, with
secondary endpoints including 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 were first
presented at the American Society of Clinical Oncology (ASCO) Plenary Series
in February 2024 and published in the New England Journal of Medicine.2

 

About DREAMM-8

DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial
evaluating the efficacy and safety of belantamab mafodotin in combination with
pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide
plus dexamethasone (PVd) 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. The trial included 302
participants who were randomised 1:1 to receive either BPd or PVd. Compared to
the patient population studied in the DREAMM-7 trial, patients in DREAMM-8
were more heavily pre-treated in that all had prior exposure to lenalidomide,
78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of
those most were daratumumab refractory. Belantamab mafodotin was administered
at a dose of 2.5mg/kg intravenously for the first cycle and 1.9mg/kg
intravenously every four weeks. The primary endpoint was PFS as per an
independent review committee, with key secondary endpoints including OS and
MRD negativity rate as assessed by next-generation sequencing. Other secondary
endpoints include ORR, DOR, safety, and patient reported and quality of life
outcomes. Results were first presented at the 2024 ASCO Annual Meeting and
published in the New England Journal of Medicine.3

 

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 enquiries
 Media:               Tim Foley                  +44 (0) 20 8047 5502  (London)
                      Madison Goring             +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn             +1 202 603 5003       (Washington DC)
                      Lyndsay Meyer              +1 202 302 4595       (Washington DC)

 Investor Relations:  Constantin Fest            +44 (0) 7831 826525   (London)
                      Annabel Brownrigg-Gleeson  +44 (0) 7901 101944   (London)
                      James Dodwell              +44 (0) 20 8047 2406  (London)
                      Mick Readey                +44 (0) 7990 339653   (London)
                      Steph Mountifield          +44 (0) 7796 707505   (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 "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

79 New Oxford Street

London

WC1A 1DG

 

 1  (#_ednref1) Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for
relapsed and refractory multiple myeloma. Blood. 2015;125(20).
doi:10.1182/blood-2014-11-568923.

 2  (#_ednref2) Hungria V, Robak P, Hus M et al. Belantamab Mafodotin,
Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug
1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1. PMID: 38828933.

 3  (#_ednref3) Dimopoulos MA, Beksac M, Pour L, Delimpasi S et al. Belantamab
Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med.
2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2. PMID:
38828951.

 4  (#_ednref4) Hungria V, Robak P, H Marek et al. Belantamab Mafodotin,
Bortezomib, and Dexamethasone Vs Daratumumab, Bortezomib, and Dexamethasone in
Relapsed/Refractory Multiple Myeloma: Overall Survival Analysis and Updated
Efficacy Outcomes of the Phase 3 Dreamm-7 Trial. Presented at the 66th
American Society of Hematology (ASH) Annual Meeting and Exposition. December
2024.

 5  (#_ednref5) National Health Service. Cancer Survival in England, cancers
diagnosed 2016 to 2020, followed up to 2021. Available at:
https://digital.nhs.uk/data-and-information/publications/statistical/cancer-survival-in-england/cancers-diagnosed-2016-to-2020-followed-up-to-2021/survival-by-cancer-group.

 6  (#_ednref6) GSK press release issued 25 November 2024. Blenrep
combinations accepted for review by the US FDA for the treatment of
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations-accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple-myeloma/.

 7  (#_ednref7) 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/.

 8  (#_ednref8) 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/.

 9  (#_ednref9) GSK press release issued 9 December 2024. Blenrep (belantamab
mafodotin) combination accepted for priority review in China in
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/.

 10  (#_ednref10) 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.

 11  (#_ednref11) 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.

 12  (#_ednref12) 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 5 March 2025.

 13  (#_ednref13) Global Cancer Observatory. International Agency for Research
on Cancer. World Health Organization. Age-Standardized Rate (World) per
100,000, Incidence, Both sexes, in 2022. Available at:
https://gco.iarc.who.int/today/en/dataviz/bars?mode=population&cancers=35&populations=100_112_191_196_203_208_233_246_250_276_300_348_352_372_380_40_428_440_442_470_498_499_528_56_578_616_620_642_643_688_70_703_705_724_752_756_8_804_807_826&types=0&sort_by=value0.
Accessed 5 March 2025.

 14  (#_ednref14) Global Cancer Observatory. International Agency for Research
on Cancer. World Health Organization. United Kingdom fact sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/826-united-kingdom-fact-sheet.pdf.
Accessed 5 March 2025.

 15  (#_ednref15) Gajra A, Zalenski A, Sannareddy A, et al. Barriers to
Chimeric Antigen Receptor T-Cell (CAR-T) Therapies in Clinical Practice.
Pharmaceut Med. 2022 Jun;36(3):163-171.

 16  (#_ednref16) Crombie J, Graff T, Falchi L, et al. Consensus
recommendations on the management of toxicity associated with CD3×CD20
bispecific antibody therapy. Blood (2024) 143 (16): 1565-1575.

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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  REAFLFIESLIDLIE