REG - GSK PLC - Japan Filing Acceptance: Blenrep Multiple Myeloma

GSKAnnouncement

17/09/2024 07:00

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RNS Number : 4071E  GSK PLC  17 September 2024

Issued: 17 September 2024, London UK

 

Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple
myeloma accepted for regulatory review in Japan

·   Regulatory submission supported by phase III head-to-head DREAMM-7 and
DREAMM-8 trials

·   If approved, Blenrep plus BorDex or PomDex could redefine
relapsed/refractory multiple myeloma treatment landscape

·   More than 7,200 new cases of multiple myeloma are diagnosed in Japan
each year 1  (#_edn1)

 

GSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of Health,
Labour and Welfare (MHLW) has accepted for review a new drug application (NDA)
for Blenrep (belantamab mafodotin) in combination with bortezomib plus
dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a
treatment for relapsed or refractory multiple myeloma. MHLW also has granted
orphan drug designation for Blenrep, which reflects the high unmet medical
need and ensures priority NDA review in multiple myeloma.

 

This is the third major regulatory filing acceptance for belantamab mafodotin
combinations in the treatment of relapsed/refractory multiple myeloma,
following marketing authorisation application acceptance 2  (#_edn2) by the
European Medicines Agency (EMA) in July 2024 and by the Medicines and
Healthcare products Regulatory Agency (MHRA) in the UK earlier this month.

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "Blenrep combinations show potential based on the results of the
DREAMM-7 and DREAMM-8 trials to redefine the treatment of relapsed/refractory
multiple myeloma. We are committed to working with health authorities
worldwide to advance Blenrep along regulatory pathways so we can bring these
additional treatment options to patients as quickly as possible."

 

Multiple myeloma presents a growing health concern in Japan, where the number
of patients diagnosed with multiple myeloma per year has increased
continuously over the last five decades. 3  (#_edn3) (, 4  (#_edn4) ) This
underscores the urgent need for more treatment options for patients in Japan,
particularly those with progressing disease that has become resistant to the
current standard of care.

 

The application is based on interim 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 combinations in relapsed or refractory multiple
myeloma. A positive overall survival (OS) trend was observed in both trials
but was not statistically significant at the time of interim analysis.
Follow-up for OS continues. The DREAMM-7 trial is evaluating belantamab
mafodotin combined with BorDex versus daratumumab plus BorDex, while the
DREAMM-8 trial is evaluating belantamab mafodotin in combination with PomDex
versus bortezomib plus PomDex.

 

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 DREAMM-7
and DREAMM-8 trials were broadly consistent with the known profiles of the
individual agents.

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable.(1, 5  (#_edn5) ) There are
approximately more than 180,000 new cases of multiple myeloma diagnosed
globally each year. 6  (#_edn6) More than 7,200 new cases of multiple myeloma
are diagnosed in Japan each year.(1)  Research into new therapies is needed
as multiple myeloma commonly becomes refractory to available treatments. 7 
(#_edn7)

 

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 BorDex compared to a combination of daratumumab and BorDex 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, including Japanese patients, were randomised at a
1:1 ratio to receive either belantamab mafodotin in combination with BorDex or
a combination of daratumumab and BorDex. 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 8  (#_edn8) 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.

 

A Japan expansion cohort is set to further evaluate the DREAMM-7 protocol in
Japanese patients. Results for Japanese participants will be presented at a
future scientific meeting.

 

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 PomDex compared to a combination of bortezomib and PomDex 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, 75% were
refractory to lenalidomide, 25% had prior daratumumab exposure and of those
most were daratumumab refractory.

 

A total of 302 participants, including Japanese patients, were randomised at a
1:1 ratio to receive either belantamab mafodotin plus PomDex, or bortezomib
plus PomDex.

 

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 9  (#_edn9) at the 2024 ASCO Annual
Meeting and published in the New England Journal of Medicine.

 

A Japan expansion cohort is set to further evaluate the DREAMM-8 protocol in
Japanese patients. Results for Japanese participants will be presented at a
future scientific meeting.

 

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, Israel and Singapore. 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 Q2 Results for 2024.

 

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 1  (#_ednref1) National Cancer Registry (Ministry of Health, Labour and
Welfare), tabulated by Cancer Information Service, National Cancer Center,
Japan. Available here: https://ganjoho.jp/reg_stat/statistics/data/dl/en.html.
Accessed 12 September 2024.

 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) Ozaki S, Handa H, Saitoh T, et al. Trends of survival in
patients with multiple myeloma in Japan: a multicenter retrospective
collaborative study of the Japanese Society of Myeloma. Blood Cancer J. 2015
Sep 18;5(9):e349.

 4  (#_ednref4) Handa H, Ishida T, Ozaki S et al. Treatment pattern and
clinical outcomes in multiple myeloma patients in Japan using the Medical Data
Vision claims database. PLoS One. 2023 Apr 6;18(4):e0283931.

 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) 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.

 7  (#_ednref7) Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for
relapsed and refractory multiple myeloma. Blood. 2015;125(20).

 8  (#_ednref8) 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/

 9  (#_ednref9) 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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