REG - GSK PLC - Blenrep combination China filing acceptance

GSKAnnouncement

09/12/2024 07:15

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20241209:nRSI2300Pa&default-theme=true

RNS Number : 2300P  GSK PLC  09 December 2024

Issued: 9 December 2024, London UK

 

Blenrep (belantamab mafodotin) combination accepted for priority review in
China in relapsed/refractory multiple myeloma

 ●    Regulatory submission supported by phase III head-to-head DREAMM-7 trial
      showing statistically significant efficacy, including overall survival
 ●    If approved, Blenrep combination could redefine multiple myeloma treatment at
      or after first relapse
 ●    Seventh major regulatory filing acceptance this year for belantamab mafodotin
      combinations in this indication, following US filing acceptance based on
      DREAMM-7 and DREAMM-8

 

 

 

GSK plc (LSE/NYSE: GSK) today announced that the National Medical Products
Administration (NMPA) of China has accepted for review a new drug application
(NDA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus
dexamethasone (BVd) as a treatment for relapsed or refractory multiple
myeloma. Earlier this year, the NMPA granted priority review for this
application as well as Breakthrough Therapy Designation
(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/)
 1  (#_edn1) for the BVd combination, which is intended to expedite
development of investigational drugs with potential for substantial
improvement over available therapies. 2  (#_edn2)

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "Today's regulatory filing acceptance, with a priority review, is a
meaningful step forward in our efforts to bring the benefits of Blenrep in
combination to patients in China. Multiple myeloma patients need new options
that may improve outcomes, particularly at first relapse. The DREAMM-7 trial
shows statistically significant efficacy, including overall survival and could
redefine treatment in this patient population."

 

This is the seventh major regulatory filing acceptance this year for
belantamab mafodotin in combination for 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 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/)
 3  (#_edn3) , 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/)
(( 4  (#_edn4) )), Japan
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-relapsedrefractory-multiple-myeloma-accepted-for-regulatory-review-in-japan/)
(( 5  (#_edn5) )) (with priority review), United Kingdom, Canada and
Switzerland (with priority review for DREAMM-8).

 

The application is based on the interim results of the phase III head-to-head
DREAMM-7 trial, which met its primary endpoint, showing statistically
significant and clinically meaningful improvement in progression-free survival
(PFS) for BVd compared to daratumumab plus bortezomib and dexamethasone (DVd)
in relapsed or refractory multiple myeloma. In a subsequent planned interim
analysis, the DREAMM-7 trial met the key secondary endpoint of overall
survival (OS), showing that BVd significantly reduced the risk of death versus
standard of care DVd.

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable. 6  (#_edn6) (, 7  (#_edn7) )
There are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year. 8  (#_edn8)  In China, multiple myeloma is a
growing health concern with approximately 30,000 new cases each year. 9 
(#_edn9) The incidence of multiple myeloma in China has doubled and mortality
has increased 1.5-fold in the past three decades. 10  (#_edn10) Research into
new therapies is needed as multiple myeloma commonly becomes refractory to
available treatments. 11  (#_edn11)

 

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/)
 12  (#_edn12) 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 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.

 

 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:  Annabel Brownrigg-Gleeson  +44 (0) 7901 101944   (London)
                      James Dodwell              +44 (0) 7881 269066   (London)
                      Mick Readey                +44 (0) 7990 339653   (London)
                      Camilla Campbell           +44 (0) 7803 050238   (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 under
Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and GSKs
Q3 Results for 2024.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

79 New Oxford Street

London

WC1A 1DG

 1  (#_ednref1) 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/.

 2  (#_ednref2) China Drug Registration Regulation. Available at:
http://www.gov.cn/gongbao/content/2020/content_5512563.htm. Accessed 1 October
2024.

 3  (#_ednref3) 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/.

 4  (#_ednref4) 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/.

 5  (#_ednref5) 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/.

 6  (#_ednref6) 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.

 7  (#_ednref7) 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.

 8  (#_ednref8) 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 1 October 2024.

 9  (#_ednref9) Global Cancer Observatory. International Agency for Research
on Cancer. World Health Organization. China fact sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf.
Accessed 12 September 2024.

 10  (#_ednref10) Liu J, Liu W, Mi L, et al. Burden of multiple myeloma in
China: an analysis of the Global Burden of Disease, Injuries, and Risk Factors
Study 2019. Chin Med J (Engl). 2023;136(23):2834-2838. Published 2023 Dec 5.
doi:10.1097/CM9.0000000000002600.

 11  (#_ednref11) 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.

 12  (#_ednref12) 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/.

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  MSCUNUURSWUURUA