- This designation is based on the results of the Phase III head-to-head DREAMM-7 study.
- This designation can accelerate the development process of the drug under research, with the potential to significantly improve efficacy compared to existing therapies.
- Since patients with multiple myeloma often relapse or become resistant to initial therapies, novel treatment options are needed.1
GSK (LSE/NYSE: GSK) recently announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted Blenrep (belantamab mafodotin for injection) Breakthrough Therapy Designation for use in combination with bortezomib and dexamethasone (BorDex) for the treatment of relapsed or refractory multiple myeloma. The NMPA’s Breakthrough Therapy Designation aims to expedite the development of treatments for serious and life-threatening diseases that either have no available therapies or where preliminary evidence suggests the breakthrough therapy offers improved patient outcomes over existing options.2
GSKSenior Vice President, Head of Global Oncology R&D Hesham Abdullah Indicates:"Receiving Breakthrough Therapy Designation in China underscores the potential of Blenrep to redefine treatment outcomes for patients with multiple myeloma who experience their first relapse or are on second-line or later therapy. We look forward to continuing our collaboration with regulatory authorities in China and globally to bring the benefits of Blenrep combination therapy to patients as soon as possible."
The breakthrough therapy designation is based on the interim analysis results of the Phase III head-to-head DREAMM-7 study, which met its primary endpoint. In patients with relapsed or refractory multiple myeloma, the group treated with injectable Marablanzumab combined with the BorDex regimen showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the group treated with Daratumumab combined with Bortezomib and Dexamethasone.
The interim analysis results also suggested a trend toward benefit in overall survival (OS) for the group receiving belantamab mafodotin injection combined with the BorDex regimen, although statistical significance was not reached. Follow-up for overall survival is still ongoing. The study results also demonstrated clinically meaningful improvements across all other secondary efficacy endpoints, with the investigational drug regimen achieving more pronounced and durable responses compared to the standard of care. In the DREAMM-7 study, the safety and tolerability profile of the combination therapy with belantamab mafodotin injection was generally consistent with the known safety profiles of the individual drugs within the combination.
In China, multiple myeloma is an increasingly concerning health issue, with approximately 30,000 new cases annually.3。 Over the past three decades, its incidence rate has doubled, and the mortality rate has increased 1.5 times.4This indicates an urgent need among Chinese patients, particularly those with disease progression who have developed resistance to existing standard treatments, for new and effective treatment options.
About Multiple Myeloma
Multiple myeloma is the third most common blood cancer globally and is often considered treatable but not curable.5,6More than approximately 180,000 new cases of multiple myeloma are diagnosed globally each year.7Multiple myeloma often develops resistance to previous treatments, creating an urgent need for new therapeutic options.8
About DREAMM-7
DREAMM-7 Phase III Clinical Study is a multicenter, open-label, randomized study that evaluates the efficacy and safety of intravenous mabranatumab in combination with BorDex compared to daratumumab in combination with BorDex for the treatment of patients with relapsed/refractory multiple myeloma. These patients have previously received at least one prior line of therapy for multiple myeloma and have documented disease progression during or after their last treatment.
A total of 494 subjects were randomly assigned in a 1:1 ratio to receive either mabelviromab for injection combined with BorDex or daratumumab combined with BorDex. Mabelviromab for injection was administered intravenously at a dose of 2.5 mg/kg every three weeks.
The primary endpoint was progression-free survival (PFS) assessed by an independent review committee. Key secondary endpoints included overall survival (OS), duration of response (DOR), and the rate of minimal residual disease (MRD)-negativity assessed through next-generation sequencing. Other secondary endpoints encompassed the overall response rate (ORR), safety, as well as patient-reported outcomes and quality of life results.
DREAMM-7 Results Were First Presented at the ASCO Plenary Series Meeting in February 2024Publish9, and was shared again at the 2024 ASCO Annual Meeting, and published in The New England Journal of Medicine.
About Blenrep
Blenrep is an antibody-drug conjugate composed of a humanized B-cell maturation antigen monoclonal antibody linked 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 subsidiary of Kyowa Kirin Group).
Blenrep as a monotherapy has been approved in Hong Kong, China, Israel, and Singapore. For a full list of adverse events and important safety information, please refer to the local product characteristics summary.
GSK Oncology Field
Oncology is an emerging therapeutic area for GSK. We are committed to maximizing patient survival through breakthroughs in cancer immunology and targeted tumor cell therapies, with a current focus on malignant hematological diseases, gynecological cancers, and other solid tumors.
About GSK
GSK is a global biopharmaceutical company with the mission of "uniting science, technology, and talent to push boundaries and overcome diseases together." For more information, please visitgsk.com
References
1 Moreau P., Kumar S, San Miguel J, et al. Treatment of relapsed and refractory multiple myeloma: recommendations from the International Myeloma Working Group. The Lancet Oncology, Volume 22, Issue 3, e105-e118.doi:10.1016/S1470-2045(20)30756-7.
2 China Drug Registration Regulation. Available at: http://www.gov.cn/gongbao/content/2020/content_5512563.htm. Accessed 12 September 2024.
3 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.
4 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.
5 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 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 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 12 September 2024.
8 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.
9 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/. Accessed 12 September 2024.