REG - GSK PLC - Blenrep approved in the EU for multiple myeloma

GSKAnnouncement

Yesterday 17:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250724:nRSX4860Sa&default-theme=true

RNS Number : 4860S  GSK PLC  24 July 2025

Issued: 24 July 2025, London UK

 

 

Blenrep (belantamab mafodotin) combinations approved in EU for treatment of
relapsed/refractory multiple myeloma

·   Two head-to-head phase III trials demonstrated superior efficacy,
including overall survival versus a daratumumab-based triplet in DREAMM-7

·   Blenrep, a first-in-class anti-BCMA ADC, could transform treatment as
early as first relapse where additional effective and accessible options are
needed 1  (#_edn1) (, 2  (#_edn2) , 3  (#_edn3) )

·   Sixth regulatory approval for Blenrep combinations with applications
under review in all major markets

 

GSK plc (LSE/NYSE: GSK) today announced the approval of Blenrep in the
European Union (EU) for the treatment of adults with relapsed or refractory
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.

 

The approval is based on superior efficacy results demonstrated by Blenrep
combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed
or refractory multiple myeloma. These include statistically significant and
clinically meaningful progression-free survival (PFS) for Blenrep combinations
versus triplet standard of care combinations in both trials and overall
survival (OS) versus a daratumumab-based triplet 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 is a redefining moment for
patients with relapsed or refractory multiple myeloma in the EU. Blenrep has
the potential to extend remission and survival, with superior efficacy versus
standards of care in our DREAMM clinical trial programme and the option to
administer in both academic and community-based settings."

 

More than 50,000 cases of multiple myeloma are diagnosed in Europe each year,
accounting for more than a quarter of global incidence. 5  (#_edn5) Blenrep is
the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC)
approved in multiple myeloma, providing patients with a differentiated
mechanism of action to potentially help slow disease progression and extend
survival.(1) Blenrep combinations can be administered to a range of patient
types across oncology treatment settings, enabling broad accessibility of an
anti-BCMA therapy.

 

María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit,
Haematology Department and Professor of Medicine at the University of
Salamanca, Spain, and DREAMM-7 principal investigator, said: "With the
approval of Blenrep combinations in the EU, we now have additional tools in
our efforts to keep patients in remission longer, maintain quality of life and
extend survival. The robust efficacy supported by the DREAMM-7 and DREAMM-8
trials, together with manageable outpatient administration in academic and
community settings, positions Blenrep combinations as a fundamentally
differentiated treatment approach for multiple myeloma patients starting from
first relapse."

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 (n=243) nearly tripled
median PFS versus the daratumumab-based comparator (n=251) (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 versus the daratumumab-based comparator (HR:
0.58; 95% CI: 0.43-0.79; p=0.00023). The median OS was not reached in either
arm of the study. The three-year OS rate was 74% in the Blenrep combination
arm and 60% in the daratumumab combination arm.(4) In DREAMM-8, at a median
follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not
yet reached  NR ) with the Blenrep combination compared to 12.7 months in the
bortezomib combination (95% CI: 9.1-18.5) at the time of primary analysis.(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)

 

DREAMM-7 and DREAMM-8 showed that eye-related side effects associated with
Blenrep can be managed and reversed with appropriate dose modifications and
follow-up. This allowed patients to maintain benefit and resulted in low rates
of discontinuation due to eye-related side effects (≤9%) 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 DREAMM-8.(2)(,)(3)

 

Blenrep combinations are also approved in relapsed or refractory multiple
myeloma in the UK
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/)
 6  (#_edn6) and Japan
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/)
 7  (#_edn7) as well as other markets, including Canada and Switzerland (based
on the results of DREAMM-8). Applications are currently under review in all
major markets globally, including 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/)
 8  (#_edn8) and China
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/)
 9  (#_edn9) (based on the results of DREAMM-7, with Breakthrough Therapy
Designation for the combination and priority review for the application).

 

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.(5)  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. 12  (#_edn12)
(, 13  (#_edn13) )

 

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 EU, Blenrep is indicated in adults for the treatment of relapsed or
refractory 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

Refer to the Blenrep
(https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep-0)
(https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep-0) EMA Reference
Information (https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep-0)  14 
(#_edn14) which will soon be available for a full list of adverse events and
the complete important safety information in the EU.

 

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 or 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 in
combination for the first eight cycles and then continued as a single agent.
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.

 

PFS results were presented at the American Society of Clinical Oncology (ASCO)
Plenary Series in February 2024 and published in the New England Journal of
Medicine. OS results were presented at the American Society of Hematology
(ASH) Annual Meeting in December 2024.2(,)(4)

 

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 or 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 then 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 Updated PFS results were presented at
the European Hematology Association (EHA) Congress in June 2025. 15  (#_edn15)

 

GSK in oncology

Our ambition in oncology is to help increase overall quality of life, maximise
survival and change the course of disease, expanding from our current focus on
blood and women's cancers into lung and gastrointestinal cancers, as well as
other solid tumours. This includes accelerating priority programmes such as
antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly
selective KIT tyrosine kinase inhibitor.

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:               Simon Steel        +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)
                      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 3126       (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, and
GSK's Q1 Results for 2025.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

79 New Oxford Street

London

WC1A 1DG

 

 1  (#_ednref1) Nooka AK, Kastritis E, Dimopoulos MA, et al. Treatment options
for relapsed and refractory multiple myeloma. Blood. 2015 May 14;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) 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.

 6  (#_ednref6) GSK press release issued 17 April 2025. Blenrep (belantamab
mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple
myeloma. Available at
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/.

 7  (#_ednref7) GSK press release issued 19 May 2025. Blenrep (belantamab
mafodotin) combinations approved in Japan for treatment of relapsed/refractory
multiple myeloma. Available at
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/.

 8  (#_ednref8) 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/.

 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) 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. doi: 10.1007/s40290-022-00428-w. Epub
2022 Jun 7.

 13  (#_ednref13) 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. doi:
10.1182/blood.2023022432.

 14  (#_ednref14) European Medicines Agency. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep-0. Accessed 8 July
2025.

 15  (#_ednref15) Dimopoulos MA, Beksac M, Pour L, et al. Updated results from
phase 3 DREAMM-8 study of Belantamab Mafodotin, Pomalidomide and Dexamethasone
versus Pomalidomide plus Bortezomib and Dexamethasone in relapsed/refractory
multiple myeloma. HemaSphere | 2025;9(S1) 846 EHA 2025 Congress.

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  REAFLFISDAISFIE