REG - GSK PLC - Blenrep combinations accepted for US FDA review

GSKAnnouncement

25/11/2024 07:00

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RNS Number : 4152N  GSK PLC  25 November 2024

Issued: 25 November 2024, London UK

 

Blenrep combinations accepted for review by the US FDA for the treatment of
relapsed/refractory multiple myeloma

·   Regulatory submission supported by phase III head-to-head DREAMM-7 and
DREAMM-8 trials showing statistically significant efficacy, including overall
survival in DREAMM-7

·   If approved, Blenrep (belantamab mafodotin) in combinations with BorDex
(BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after
first relapse

·   Sixth major regulatory filing acceptance this year for belantamab
mafodotin combinations in this indication

·   US decision expected by 23 July 2025

 

 

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration
(FDA) has accepted for review a Biologics License Application (BLA) for
Blenrep (belantamab mafodotin) in combinations with bortezomib plus
dexamethasone (BorDex  BVd ) and pomalidomide plus dexamethasone (PomDex
 BPd ) for the treatment of patients with multiple myeloma who have received
at least one prior line of therapy. The US FDA has assigned a Prescription
Drug User Fee Act action date of 23 July 2025.

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "Relapsed/refractory multiple myeloma treatment could be transformed by
additional, efficacious treatment options with manageable side effects and
community-based administration. The evidence from DREAMM-7 and DREAMM-8
supporting our Blenrep combinations submission has been further strengthened
by the statistically significant overall survival results from the DREAMM-7
trial. We look forward to working with the FDA on this review."

 

The US application is based on results from the DREAMM-7 and DREAMM-8 phase
III trials, which both met their primary endpoints, showing statistically
significant and clinically meaningful improvements in progression-free
survival (PFS) for the belantamab mafodotin combinations compared to standard
of care triplet combinations in relapsed or refractory multiple myeloma.

 

Results from both trials also showed clinically meaningful improvements across
all other secondary efficacy endpoints, including deeper and more durable
responses compared to the respective standard of care combinations. The safety
and tolerability profiles of the belantamab mafodotin combinations in the
DREAMM-7 and DREAMM-8 trials were broadly consistent with the known profiles
of the individual agents.

 

In a subsequent planned interim analysis, the DREAMM-7 trial also met the key
secondary endpoint of overall survival
(https://www.gsk.com/en-gb/media/press-releases/blenrep-shows-overall-survival-benefit-in-head-to-head-dreamm-7-phase-iii-trial-for-relapsedrefractory-multiple-myeloma/)
 1  (#_edn1) (OS), showing a statistically significant and clinically
meaningful OS benefit favouring the belantamab mafodotin combination. Efficacy
and safety data from this analysis will be presented at the upcoming 66th
American Society of Hematology (ASH) Annual Meeting and Exposition on 9
December 2024 at 11:15 a.m. PT. A positive trend in OS was observed in
DREAMM-8 but was not statistically significant at the time of interim
analysis, and follow-up for OS continues.

 

This is the sixth major regulatory filing acceptance this year for belantamab
mafodotin combinations in the treatment of relapsed or refractory multiple
myeloma based on the results of the DREAMM-7 and DREAMM-8 trials. In 2024,
belantamab mafodotin combinations have been accepted for review in the
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/)
(( 2  (#_edn2) )), Japan
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-relapsedrefractory-multiple-myeloma-accepted-for-regulatory-review-in-japan/)
(( 3  (#_edn3) )) (with priority review), United Kingdom, Canada and
Switzerland (with priority review for DREAMM-8). In China
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-in-combination-receives-breakthrough-therapy-designation-in-china-for-treatment-of-relapsedrefractory-multiple-myeloma/)
 4  (#_edn4) , the National Medical Products Administration has granted
Breakthrough Therapy Designation for belantamab mafodotin in combination with
bortezomib and dexamethasone, as well as priority review for the regulatory
application based on the results of DREAMM-7.

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable. 5  (#_edn5) (, 6  (#_edn6) )
There are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year. 7  (#_edn7) Multiple myeloma is a significant
and enduring health concern in the US, where more than 35,000 cases are
expected to be diagnosed in 2024.(6)(, 8  (#_edn8) ) Research into new
therapies is needed as multiple myeloma commonly becomes refractory to
available treatments. 9  (#_edn9)

 

About DREAMM-7

The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised
trial evaluating the efficacy and safety of belantamab mafodotin in
combination with bortezomib plus dexamethasone (BVd) compared to a combination
of daratumumab and 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.

 

A total of 494 participants were randomised at a 1:1 ratio to receive either
BVd or DVd. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg
intravenously every three weeks.

 

The primary endpoint is PFS as per an independent review committee. The key
secondary endpoints include 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 from DREAMM-7 were first presented
(https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/)
 10  (#_edn10) at the American Society of Clinical Oncology (ASCO) Plenary
Series in February 2024, shared in an encore presentation at the 2024 ASCO
Annual Meeting, and published in the New England Journal of Medicine.

 

About DREAMM-8

The DREAMM-8 phase III clinical trial is a multicentre, open-label, randomised
trial evaluating the efficacy and safety of belantamab mafodotin in
combination with pomalidomide plus dexamethasone (BPd) compared to a
combination of 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. 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.

 

A total of 302 participants were randomised at a 1:1 ratio to receive either
BPd or PVd.

 

The primary endpoint is PFS as per an independent review committee. The key
secondary endpoints include 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 from DREAMM-8 were first presented
(https://www.gsk.com/en-gb/media/press-releases/blenrep-combination-reduced-the-risk-of-disease-progression/)
 11  (#_edn11) at the 2024 ASCO Annual Meeting and published in the New
England Journal of Medicine.

 

About Blenrep

Blenrep is an antibody-drug conjugate comprising a humanised B-cell
maturation antigen 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.

 

Blenrep is approved as monotherapy in Hong Kong. Refer to the local Summary of
Product Characteristics for a full list of adverse events and complete
important safety information.

 

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.

 

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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 under
Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q3 Results for 2024.

 

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WC1A 1DG

 1  (#_ednref1) GSK press release issued 14 November 2024. Blenrep shows
overall survival benefit in head-to-head DREAMM-7 phase III trial for
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-shows-overall-survival-benefit-in-head-to-head-dreamm-7-phase-iii-trial-for-relapsedrefractory-multiple-myeloma/.

 2  (#_ednref2) 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/.

 3  (#_ednref3) 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/.

 4  (#_ednref4) GSK press release issued 13 September 2024. Blenrep
(belantamab mafodotin) in combination receives Breakthrough Therapy
Designation in China for treatment of relapsed/refractory multiple myeloma.
Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-in-combination-receives-breakthrough-therapy-designation-in-china-for-treatment-of-relapsedrefractory-multiple-myeloma/.

 5  (#_ednref5) 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.

 6  (#_ednref6) 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.

 7  (#_ednref7) 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 July 2024.

 8  (#_ednref8) American Cancer Society Cancer Statistics Center. Myeloma.
https://cancerstatisticscenter.cancer.org/#!/cancer-site/Myeloma. Accessed
April 2024.

 9  (#_ednref9) Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for
relapsed and refractory multiple myeloma. Blood. 2015;125(20).

 10  (#_ednref10) GSK press release issued 05 February 2024. DREAMM-7 phase
III trial shows Blenrep combination nearly tripled median progression-free
survival versus standard of care combination in patients with
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/.

 11  (#_ednref11) GSK press release issued 02 June 2024. Blenrep combination
reduced the risk of disease progression or death by nearly 50% versus standard
of care combination in relapsed/refractory multiple myeloma Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-combination-reduced-the-risk-of-disease-progression/.

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