Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma

• Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7  
• Blenrep combinations could redefine treatment as early as first relapse where more effective options are needed^1,2,3
• First and only approved anti-BCMA-ADC for the treatment of multiple myeloma in Canada

MISSISSAUGA, ON, July 23, 2025 /CNW/ - GSK announced today that Health Canada has approved Blenrep (belantamab mafodotin for injection) in combination with bortezomib and dexamethasone, or in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including lenalidomide for the latter combination.

BLENREP logo (CNW Group/GlaxoSmithKline Inc.)

Superior efficacy results, when compared to standard of care, from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support the approval of the Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results versus standards of care in both trials and overall survival (OS) in DREAMM-7.^2,3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.^2,3  

"The approval of Blenrep in Canada represents an advancement for patients with multiple myeloma, a challenging condition marked by repeated cycles of remission and relapse," said Michelle Horn, Country Medical Head, GSK Canada. "As the only BCMA-targeted antibody-drug conjugate, Blenrep has been shown to extend survival and remission, supported by data from the DREAMM-7 and DREAMM-8 phase III clinical trials. This approval marks a milestone in offering a treatment option that holds the promise to transform the therapeutic approach for patients facing their first or subsequent relapses."

Blenrep is the first and only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) for multiple myeloma, providing patients facing their first and subsequent relapses with a differentiated mechanism of action. Blenrep combinations can be administered to a broad range of patient types without complex pre-administration regimens or hospitalization.

"As patients with multiple myeloma receive combination therapies at diagnosis, the availability of diverse treatment options like Blenrep is vital for prolonging remission and enhancing survival outcomes," said Martine Elias, Chief Executive Officer of Myeloma Canada. "This milestone represents a transformative step forward in the treatment landscape, empowering our community and reinforcing our commitment to making myeloma matter while driving progress toward a cure."

In the DREAMM-7 and DREAMM-8 clinical trials, Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators.^2,3 

The most common adverse reactions, occurring in ≥20% of patients, were reduced visual acuity (BCVA), corneal examination findings, blurred vision, dry eye, photophobia, foreign body sensation in eyes, eye irritation, eye pain, cataract, upper respiratory tract infection, pneumonia, fatigue, thrombocytopenia, diarrhea, and peripheral sensory neuropathy.  Eye-related side effects, a known side effect of treatment with Blenrep, were manageable with extended time between infusions and dose reductions, while maintaining efficacy, and led to low (≤9%) treatment discontinuations in both trials.^2,3 

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.^5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.⁷ Multiple myeloma is a significant concern in Canada, where in 2024 alone, 4,000 people were diagnosed with the disease.⁸ Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.¹ 

About Blenrep 
Blenrep is an ADC comprising a humanized BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker.

In Canada, Blenrep (belantamab mafodotin for injection) is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Specifically, Blenrep is indicated:

• in combination with bortezomib and dexamethasone (BVd), in adult patients who have received at least one prior therapy; and
• in combination with pomalidomide and dexamethasone (BPd), in adult patients who have received at least one prior line of therapy, including lenalidomide.

Please consult the Product Monograph at http://www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomized 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 adult patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy. The trial enrolled 494 participants who were randomized 1:1 to receive either BVd or DVd for eight cycles, after which patients received belantamab mafodotin or daratumumab as a monotherapy. 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. Other secondary endpoints include overall response rate (ORR), safety, and patient-reported quality-of-life outcomes.

The Blenrep combination demonstrated a statistically significant and clinically meaningful improvement in PFS. The median PFS was 36.6 months (95% CI: 28.4-not reached [NR]) with BVd compared to 13.4 months (11.1-17.5) with DVd (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). For Overall Survival (OS), at the first pre-planned interim analysis, the hazard ratio was 0.57; 95% CI, 0.40, 0.80, indicating a 43% reduction in the risk of death in favour of BVd. More recently, the updated OS results were statistically significant and maintained the reduction in the risk of death in favour of BVd. These results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2024.^2,4 These findings were consistently observed in subgroups and supported by secondary endpoints.

About DREAMM-8
DREAMM-8 is a multicentre, open-label, randomized 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 adult patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen. The trial included 302 participants who were randomized 1:1 to receive either BPd or PVd.  Patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 81% were refractory to lenalidomide, 25% had prior anti-CD38 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 then 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 quality-of-life outcomes.

In DREAMM-8, the Blenrep combination demonstrated a statistically significant and clinically meaningful improvement in PFS, with a 48% reduction in the risk of disease progression or death compared to PVd (HR: 0.52 [95% CI: 0.37-0.73], p-value<0.001). At the primary analysis, with 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. Recently, in an updated interim analysis, after a median follow-up of 28.01 months, the mPFS in the BPd arm was 32.6 months compared with 12.5 months in the PVd arm. These results were presented at the European Hematology Association (EHA) Annual Meeting in June 2025.⁹

The clinical 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.

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.ca.

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

_______________________

¹ 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.

² 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.

³ 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.

⁴ 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

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 5 March 2025.

⁸ Multiple myeloma statistics. Canadian Cancer Society. Available at: https://cancer.ca/en/cancer-information/cancer-types/multiple-myeloma/statistics. Accessed 11 July 2025.

⁹ UPDATED RESULTS FROM PHASE 3 DREAMM-8 STUDY OF BELANTAMAB MAFODOTIN... - Dimopoulos M - EHA-3268 - Jun 13 2025, Available at: https://library.ehaweb.org/eha/2025/eha2025-congress/4160135/meletios.dimopoulos.updated.results.from.phase.3.dreamm-8.study.of.belantamab.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3Dpf728

SOURCE GlaxoSmithKline Inc.

GSK media enquiries: [phone]