GSK’s Blenrep Combinations Receive Approval in Japan for Relapsed or Refractory Multiple Myeloma Treatment

(IN BRIEF) GSK has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Blenrep combinations to treat adults with relapsed or refractory multiple myeloma. The approval follows positive results from the DREAMM-7 and DREAMM-8 phase III trials, showing superior progression-free survival (PFS) and overall survival (OS) in patients who had previously received at least one therapy. Blenrep’s unique anti-BCMA mechanism provides a differentiated treatment option in this area of high unmet need. The approval marks the second major regulatory win for Blenrep combinations, following recent authorisation in the UK, with further approvals expected in major markets globally, including the US and Europe.

(PRESS RELEASE) LONDON, 19-May-2025 — /EuropaWire/ — GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Blenrep (belantamab mafodotin) combinations in the treatment of adults with relapsed or refractory multiple myeloma. This approval follows the promising results from the DREAMM-7 and DREAMM-8 phase III trials, which evaluated Blenrep in combination with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy. The approval also comes after Blenrep received orphan drug designation in Japan, highlighting its potential to address the high unmet need for multiple myeloma treatments.

The approval was based on superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 trials, which demonstrated statistically significant and clinically meaningful progression-free survival (PFS) benefits for Blenrep combinations compared to standard-of-care treatments in both trials. In addition, overall survival (OS) benefits were observed in the DREAMM-7 trial. These findings underscore the potential of Blenrep combinations to redefine treatment options for patients at or after first relapse, an area where more effective options are critically needed.

Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, commented: “Today’s approval represents a significant step forward in providing patients with relapsed or refractory multiple myeloma in Japan with improved treatment options. Blenrep combinations have shown superior efficacy in two major phase III trials, offering an opportunity to extend remission and survival compared to standard of care. Additionally, these combinations can be administered in both academic and community settings, offering greater flexibility and convenience to patients and healthcare providers.”

Multiple myeloma is a cancer that most often relapses, and in Japan, only around 43% of patients remain alive five years after diagnosis. Blenrep is the first anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) approved for multiple myeloma, offering patients a differentiated mechanism of action at or after relapse. Blenrep combinations can be administered across various patient types and in any oncology setting without the need for complex pre-administration regimens or hospitalisation.

The results from the DREAMM-7 and DREAMM-8 trials demonstrated the efficacy of Blenrep combinations in improving outcomes across a broad range of patients, including those with high-risk cytogenetics or those refractory to lenalidomide. Both trials showed clinically meaningful improvements across other secondary efficacy endpoints, with deeper and more durable responses observed compared to the respective comparators.

While some eye-related side effects were reported with Blenrep, they were effectively managed by adjusting the infusion schedule and reducing doses, resulting in low discontinuation rates (≤9%). Most ocular issues, such as changes in visual clarity, resolved in 83% of cases. Importantly, no confirmed cases of permanent bilateral vision loss have been reported based on clinical trial data and previous post-marketing use. The most commonly reported non-ocular adverse events included thrombocytopenia, diarrhoea, neutropenia, and COVID-19.

This approval marks the second major regulatory win for Blenrep combinations in the treatment of relapsed or refractory multiple myeloma, following the first authorisation last month by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The Blenrep combinations are also under review in several other global markets, including the US, with a Prescription Drug User Fee Act (PDUFA) date set for 23 July 2025, as well as the European Union, China, Canada, and Switzerland.

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.10,11 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year, including more than 7,200 in Japan.12,13,14,15 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.1 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.16,17

About Blenrep

Blenrep is an ADC comprising a humanised BCMA 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.

In April 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) licensed Blenrep combinations for the treatment of relapsed or refractory multiple myeloma in adult patients who have received at least one prior therapy.

Indication

In Japan, Blenrep is indicated for the treatment of adults with relapsed or refractory multiple myeloma.

IMPORTANT SAFETY INFORMATION FOR BLENREP

Please refer to the updated Product Information (PI) for precautions concerning indications, dosage and administration, and safety information in Japan which will shortly be updated at this link: Japan Pharmaceuticals and Medical Devices Agency.18

About DREAMM-7

DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or 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. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including 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.

In DREAMM-7, BVd nearly tripled median PFS versus DVd (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001). DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The three-year OS rate was 74% in the BVd arm and 60% in the DVd arm.

PFS results were presented at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024 and published in the New England Journal of Medicine. OS results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2024.2,4

About DREAMM-8

DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or 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. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. 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. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including 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.

In DREAMM-8, a statistically significant and clinically meaningful improvement in PFS (HR: 0.52 [95% CI: 0.37-0.73], p-value<0.001) was observed with BPd (n=155) compared to PVd (n=147). At a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with BPd compared to 12.7 months (95% CI: 9.1-18.5) for PVd. At the end of one year, 71% (95% CI: 63-78) of patients in the BPd combination group compared to 51% (95% CI: 42-60) in the PVd combination group were alive and had not progressed. A benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics. A positive OS trend was observed but not statistically significant (HR: 0.77 [95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and further analyses are planned.

Results were first presented at the 2024 ASCO Annual Meeting and published in the New England Journal of Medicine.3

GSK in oncology

Our ambition in oncology is to help increase overall quality of life, maximise survival and change the course of disease, expanding from our current focus on blood and women’s cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor.

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.

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 in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q1 Results for 2025.

References

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.
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.
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.
GSK data on file.
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 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/.
GSK press release issued 9 December 2024. Blenrep (belantamab mafodotin) combination 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.
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.
Global Cancer Observatory. International Agency for Research on Cancer. World Health Organization. Age-Standardized Rate (World) per 100,000, Incidence, Both sexes, in 2022. Available at: https://gco.iarc.who.int/today/en/dataviz/bars?mode=population&cancers=35&populations=100_112_191_196_203_208_233_246_250_276_300_348_352_372_380_40_428_440_442_470_498_499_528_56_578_616_620_642_643_688_70_703_705_724_752_756_8_804_807_826&types=0&sort_by=value0. Accessed 5 March 2025.
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.
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.
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.
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.
Japan Pharmaceuticals and Medical Devices Agency website: https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html.