REG - GSK PLC - positive CHMP opinion on Blenrep in EU

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RNS Number : 9702J  GSK PLC  23 May 2025

Issued: 23 May 2025, London UK

 

 

Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in
relapsed/refractory multiple myeloma

·   Positive opinion supported by superior efficacy shown in two
head-to-head phase III trials, including overall survival in DREAMM-7

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

·    Approval decision expected in Q3 2025

 

GSK plc (LSE/NYSE: GSK) today announced the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended
the approval of Blenrep 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. An approval
decision by the European Commission is expected in the third quarter of 2025.

 

The CHMP opinion follows the approval of Blenrep combinations by the UK
Medicines and Healthcare products Regulatory Agency (MHRA) in April and
Japan's Ministry of Health, Labour and Welfare earlier this month.

 

Superior efficacy results shown by Blenrep combinations in the pivotal
DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple
myeloma support the CHMP opinion. 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)
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 positive CHMP opinion is an important milestone toward bringing
the benefits of Blenrep combinations to patients with multiple myeloma in
Europe. Blenrep is well positioned to address the unmet needs of these
patients while also providing the benefit of in-office administration in both
academic and community treatment settings without complex pre-administration
regimens or hospitalisation."

 

There are approximately 50,000 new cases of multiple myeloma diagnosed each
year in Europe, and nearly all patients will experience relapse from initial
treatment.(1, 5  (#_edn5) ) Blenrep is the only anti-BCMA (B-cell maturation
antigen) antibody-drug conjugate (ADC) agent in multiple myeloma, providing
patients at or after first relapse with a differentiated mechanism of action.
Blenrep combinations can be administered to a range of patient types in any
oncology treatment setting.

 

DREAMM-7 and DREAMM-8 showed that any eye-related side effects associated with
Blenrep can be managed and reversed with appropriate dose modifications and
follow-up, allowing patients to maintain benefit and resulting in low rates of
discontinuation (≤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 the Blenrep
combination arm of DREAMM-8.

 

Blenrep combinations are currently under review in all major markets globally,
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/)
 6  (#_edn6) with a Prescription Drug User Fee Act (PDUFA) date of 23 July
2025, China
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/)
 7  (#_edn7) (based on the results of DREAMM-7, with Breakthrough Therapy
Designation for the combination and priority review for the application),
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. 8  (#_edn8) (, 9  (#_edn9) )
There are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year. 10  (#_edn10) 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. 11  (#_edn11) (, 12  (#_edn12) )

 

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 available on the MHRA
Products website (https://products.mhra.gov.uk/) . 13  (#_edn13)

 

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. 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.

 

In DREAMM-7, BVd nearly tripled median PFS versus DVd (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). 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
BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The
three-year OS rate was 74% in the BVd arm and 60% in the DVd arm.

 

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 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.

 

In DREAMM-8, a statistically significant and clinically meaningful improvement
in PFS (HR: 0.52 [95% CI: 0.37-0.73], p-value<0.001) was observed with BPd
(n=155) compared to PVd (n=147). 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 BPd
compared to 12.7 months (95% CI: 9.1-18.5) for PVd. At the end of one year,
71% (95% CI: 63-78) of patients in the BPd combination group compared to 51%
(95% CI: 42-60) in the PVd combination group were alive and had not
progressed. A benefit for BPd was observed across all pre-specified subgroups
including those with poor prognostic features, such as patients who were
refractory to lenalidomide and patients with high-risk cytogenetics. A
positive OS trend was observed but not statistically significant (HR: 0.77
[95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and
further analyses are planned.

 

Results were first presented at the 2024 ASCO Annual Meeting and published in
the New England Journal of Medicine.3

 

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.

 

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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 in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.

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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) 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 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 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/.

 8  (#_ednref8) 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.

 9  (#_ednref9) 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.

 10  (#_ednref10) 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.

 11  (#_ednref11) 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.

 12  (#_ednref12) 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.

 13  (#_ednref13) Medicines & Healthcare products Regulatory Agency
website: https://products.mhra.gov.uk/.

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