- Two head-to-head Phase III trials have confirmed thatBlenrepTheThe卓越疗效of the combination therapy regimen; wherein the DREAMM-7 study demonstrated that this regimen provides a significant benefit in overall survival compared to the triplet therapy based on daratumumab.
- Blenrep As the world's first targeted BCMA antibody-drug conjugate (ADC), it has the potential to offer a new treatment option at the first relapse stage for patients, addressing the urgent need of such patients for more effective and accessible therapeutic choices.¹,²,³
- ContainingBlenrepThe combination therapy has now received six regulatory approvals worldwide, and its marketing application is currently under review in all major global markets.
GSK (LSE/NYSE：GSK）7Month24Announced on [Date],BlenrepHas obtained the EU (EU) approved for the following indications: in combination with bortezomib and dexamethasone (BVd), for adult patients with relapsed or refractory multiple myeloma who have previously received at least one prior line of therapy; or in combination with pomalidomide and dexamethasone (BPd), for adult patients with relapsed or refractory multiple myeloma who have previously received at least one prior line of therapy (including treatment containing lenalidomide).
This approval is based onBlenrepThe combination therapy regimen in pivotalIII Phase Trial DREAMM-7 And DREAMM-8The superior efficacy results demonstrated in China. In these two trials for relapsed or refractory multiple myeloma, containingBlenrepThe combination therapy regimen compared to the standard triple therapy showed statistically and clinically significant progression-free survival (PFS) Improvement; and in DREAMM-7 In the trial, containingBlenrepThe combination therapy regimen demonstrated an overall survival (OSOS) Benefit²,³,⁴. ContainingBlenrepThe safety and tolerability profile of the combination therapy regimen are generally consistent with the known characteristics of each individual drug mentioned above.²,³。
GSKSenior Vice President, Head of Global Oncology R&DHesham AbdullahIndicates:“This EU approval containsBlenrepOfThe combination therapy represents a milestone moment in reshaping the treatment landscape for patients with relapsed or refractory multiple myeloma. Based onDREAMM Results of the clinical trial project,BlenrepCompared with standard treatment, it shows better efficacy, which is not only expected to prolong patients' remission and survival periods but also is not restricted by the treatment location, allowing treatment to be carried out in both large medical institutions and grassroots medical institutions.”
Europe sees over 50,000 newly diagnosed cases of multiple myeloma each year, accounting for more than a quarter of the global incidence.⁵。BlenrepIs currently the only approved targeted therapy for multiple myelomaBCMA（B Antibody-drug conjugates (ADCs) targeting mature cell antigens (ADC), its unique mechanism of action is expected to delay disease progression and extend patient survival.¹.ContainingBlenrepTheCombination therapy can be applied to different patient populations across various treatment settings, further expanding targeted BCMA Accessibility of treatment.
Professor of Medicine at the University of Salamanca, Spain, and Director of the Myeloma and Clinical Trials Unit in the Hematology Department,DREAMM-7Principal InvestigatorMaría-Victoria MateosDr. said: "WithBlenrepOfThe approval of the combination therapy in the EU provides us with more means to help patients prolong remission, maintain quality of life, and extend survival. Based onDREAMM-7 And DREAMM-8 The significant efficacy validated by the institute, as well as its outpatient medication administration protocol that can be implemented in both large medical centers and grassroots medical institutions, includingBlenrepThe combination therapy regimen will provide a truly differentiated new treatment option for patients with multiple myeloma starting from the first relapse stage.”
DREAMM-7 and DREAMM-8 studies both show that, in second-line and later-line treatment of multiple myeloma, regimens containingBlenrepThe combination therapy regimen showed a statistically significant and clinically meaningful improvement in PFS compared to the standard triple therapy².,³. In DREAMM-7, the median PFS in the BVd group (n=243) was nearly three times longer than that in the DVd-based control group (n=251) (36.6 months vs. 13.4 months, respectively) (Hazard Ratio [HR]: 0.41 [95% Confidence Interval (CI): 0.31-0.53], p-value <0.00001)². In the DREAMM-7 study, OS, as a key secondary endpoint, was also reached. At a median follow-up of 39.4 months, the BVd group showed a significant 42% reduction in the risk of death compared to the DVd control group, with the difference being both statistically and clinically significant (HR: 0.58; 95% CI: 0.43-0.79; p=0.00023). The median OS for both groups has not yet been reached.Blenrep'sThe three-year OS rate in the combination therapy group was 74%, compared to 60% in the daratumumab-containing combination therapy group⁴. In DREAMM-8, with a median follow-up of 21.8 months,BlenrepThe median PFS in the combination regimen group has not yet been reached (95% CI: 20.6–not reached [NR]), compared to 12.7 months (95% CI: 9.1–18.5) in the bortezomib combination treatment group³.
ContainingBlenrepTheThe combination therapy regimen has demonstrated consistent benefits across a broad patient population, including patients with poor prognostic characteristics or outcomes, such as those with high-risk cytogenetic features or patients refractory to lenalidomide. The two studies also showed benefits across all other secondary efficacy endpoints, includingBlenrepTheThe combination therapy regimen achieved clinically meaningful improvements compared to their respective control groups, including deeper and more durable relief.²,³。
DREAMM-7 And DREAMM-8 Research confirms,BlenrepRelevant ocular side effects can be effectively managed and reversed through appropriate dose adjustments and follow-up, allowing patients to maintain benefits: In two trials, the discontinuation rate due to ocular side effects was low (≤9%）²,³. IncludingBlenrepIn the combination therapy regimen group, the most frequently reported non-ocular adverse events (incidence rate>30% ) In DREAMM-7 China for thrombocytopenia (87%`) and diarrhea (`32%), in DREAMM-8 Neutropenia (63%), Thrombocytopenia (55%) and COVID-19Infection (37%）²,³。
ContainingBlenrepThe combination therapy regimen has also been approved by the UK.⁶, Japan⁷And other markets, including Canada and Switzerland (based on DREAMM-8 The results) approved for the treatment of relapsed or refractory multiple myeloma. This regimen is currently under review in all major global markets, including the United States.⁸And China⁹(Based on DREAMM-7 As a result, the combination therapy received Breakthrough Therapy Designation, and its marketing application was granted Priority Review status).
About Multiple Myeloma
Multiple myeloma is the third most common blood cancer globally and is often considered treatable but not curable.¹⁰,¹¹. More than approximately XX new cases of multiple myeloma are confirmed globally each year. 180,000 Example⁵Multiple myeloma often develops resistance to previous treatments, creating an urgent need for new therapeutic options.¹Many patients with multiple myeloma are treated at community cancer facilities, and there is an urgent need for novel, effective therapies with manageable side effects that can be administered outside of large medical centers.¹²,¹³。
AboutBlenrep
Blenrep It is an antibody-drug conjugate, consisting of humanized B Cell maturation antigen monoclonal antibody is linked to cytotoxic drugs through a non-cleavable linkerauristatin F Conjugated. The drug linker technology is by Seagen Inc.Authorization; Monoclonal Antibody Use BioWa Inc.（Kyowa KirinGroup Subsidiary) AuthorizedPOTELLIGENTTechnical Production.
Indications
In the EU,BlenrepIndicated for the treatment of adult patients with relapsed or refractory multiple myeloma:
- In combination with bortezomib and dexamethasone, for patients who have received at least one prior therapy; and
- In combination with pomalidomide and dexamethasone, for patients who have previously received at least one prior therapy (including lenalidomide-containing regimens).
BLENREP Important Safety Information
Please refer to the EMA reference information for Blenrep¹⁴ (to be published soon) for the complete list of adverse events and full important safety information in the EU.
About DREAMM-7
DREAMM-7 III The phase clinical study is a multicenter, open-label, randomized study in combination with daratumumab, bortezomib, and dexamethasone (DVd) Treatment Comparison: Evaluation of Maribavirumab Injection Combined with Bortezomib and Dexamethasone (BVd) Treatment of Recurrent/Efficacy and safety in patients with relapsed and refractory multiple myeloma who have previously received at least one prior therapy for multiple myeloma and have documented disease progression during or after their most recent therapy.
Total 494 Name of the subject, by 1:1 Randomized Allocation AcceptanceBVdOrDVdTreatment. The administration of Maribavir injection is: combination therapy phase (initial8Per cycle) once every three weeks intravenously,2.5mg/kg; Subsequent single-agent maintenance therapy.
The primary endpoint is progression-free survival (PFS) assessed by an independent review committee.PFS). Key secondary endpoints include overall survival (OS), Response Duration (DOR) and minimal residual disease (MRD) assessed by next-generation sequencing (MRD) Negative rate. Other secondary endpoints include overall disease response rate (ORR), safety, as well as patient-reported and quality-of-life outcomes.
PFS Results on 2024 Year 2 Month in the American Society of Clinical Oncology (ASCO) was first announced at the plenary session series and published in The New England Journal of Medicine.OS Results as of 2024 Year 12 Month in the American Society of Hematology (ASH) Announced at the Annual Meeting²,⁴。
About DREAMM-8
DREAMM-8 III The phase clinical study is a multicenter, open-label, randomized study comparing the treatment regimens of bortezomib combined with pomalidomide and dexamethasone (PVd) versus marabancept combined with pomalidomide and dexamethasone (BPd) Treatment of Recurrent/Efficacy and safety in patients with relapsed or refractory multiple myeloma who have previously received at least one prior line of therapy for multiple myeloma, including treatment regimens containing lenalidomide, and have documented disease progression during or after their most recent therapy.
Total302Subject, by 1:1 Randomized Allocation AcceptancePVdOrBPdTreatment. And DREAMM-7Compared to the patient population in the study,DREAMM-8 Patients in China had a heavier prior treatment burden: all patients had previously received lenalidomide treatment,78% Refractory to lenalidomide;25% The patient had previously received daratumumab, and the majority were refractory to daratumumab. The administration of marabancept injection was as follows: in the first cycle, 2.5 mg/kg The dose was administered intravenously, followed by every four weeks with 1.9 mg/kg Administered intravenously at a dose of.
The primary endpoint was assessed by the Independent Review Committee.PFS. Key secondary endpoints includeOSAnd evaluated through next-generation sequencing technologyMRDNegative rate. Other secondary endpoints includeORR、DOR, safety, as well as patient-reported and quality-of-life outcomes.
The research results were first published in 2024 Year ASCO Announced at the annual meeting and published in The New England Journal of Medicine³. Updated PFS Results on 2025 Year 6 Month in the European Hematology Association (EHA) Announced at the Conference¹⁵。
GSK Oncology Field
Tumor isGSKIn the emerging field of treatment, we are committed to maximizing patient survival rates through breakthroughs in tumor immunology and tumor cell-targeted therapies. Our current focus is on malignant hematological diseases and gynecological cancers, gradually expanding to lung cancer, gastrointestinal tumors, and other solid tumor areas. To achieve this goal, we are advancing several key strategic projects, including: targetedB7-H3/B7-H4Antibody-drug conjugates, as well as highly selectiveKITTyrosine Kinase InhibitorIDRX-42。
About GSK
GlaxoSmithKline (GSK) is a“Unite Science, Technology, and Talent to Overcome Diseases Together”A global biopharmaceutical company on a mission. For more information, please visitgsk.com。
Cautionary Statement Regarding Forward-Looking Statements
GSK Alert investors, by GSK Any forward-looking statements or forecasts made (including the statements contained in this announcement) are subject to risks and uncertainties, which may cause actual results to differ materially from the forecasts. These factors include, but are not limited to GSK 2024 Year 20-F In the table annual report“Risk Factors”Chapter and GSK 2025 Content contained in the Q1 earnings report.
References
- Nooka AK, Kastritis E, Dimopoulos MA, et al. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015 May 14;125(20). doi:10.1182/blood-2014-11-568923.
- 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.
- 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.
- 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.
- 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.
- GSK press release issued 17 April 2025. Blenrep (belantamab mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple myeloma. Available at https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/.
- GSK press release issued 19 May 2025. Blenrep (belantamab mafodotin) combinations approved in Japan for treatment of relapsed/refractory multiple myeloma. Available at https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/.
- 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/.
- GSK press release issued 9 December 2024. Blenrep (belantamab mafodotin) combinations 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/.
- 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.
- 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.
- 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. doi: 10.1007/s40290-022-00428-w. Epub 2022 Jun 7.
- 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. doi: 10.1182/blood.2023022432.
- European Medicines Agency. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep-0. Accessed 8 July 2025.
- Dimopoulos MA, Beksac M, Pour L, et al. Updated results from phase 3 DREAMM-8 study of Belantamab Mafodotin, Pomalidomide and Dexamethasone versus Pomalidomide plus Bortezomib and Dexamethasone in relapsed/refractory multiple myeloma. HemaSphere | 2025;9(S1) 846 EHA 2025 Congress.