CLINICAL TRIALS PROFILE FOR BLENREP

All Clinical Trials for BLENREP

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02343042 ↗	Selinexor and Backbone Treatments of Multiple Myeloma Patients	Recruiting	Karyopharm Therapeutics Inc	Phase 1/Phase 2	2015-10-01	This study will independently assess the efficacy and safety of 10 combination therapies in 11 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: - Arm 1: Selinexor + dexamethasone + pomalidomide (SPd) - Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete - Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete - Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd) - Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete - Arm 6: Selinexor + dexamethasone + carfilzomib (SKd) - Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM - Arm 8: Selinexor + dexamethasone + ixazomib (SNd) - Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd) - Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd) - Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd) Selinexor pharmacokinetics: - PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 [SPVd], Arm 6 [SKd], Arm 8 [SNd], Arm 9 [SPEd], Arm 10 [SBd], and Arm 11 [SDPd]) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor.
NCT02343042 ↗	Selinexor and Backbone Treatments of Multiple Myeloma Patients	Recruiting	Karyopharm Therapeutics, Inc	Phase 1/Phase 2	2015-10-01	This study will independently assess the efficacy and safety of 10 combination therapies in 11 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: - Arm 1: Selinexor + dexamethasone + pomalidomide (SPd) - Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete - Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete - Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd) - Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete - Arm 6: Selinexor + dexamethasone + carfilzomib (SKd) - Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM - Arm 8: Selinexor + dexamethasone + ixazomib (SNd) - Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd) - Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd) - Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd) Selinexor pharmacokinetics: - PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 [SPVd], Arm 6 [SKd], Arm 8 [SNd], Arm 9 [SPEd], Arm 10 [SBd], and Arm 11 [SDPd]) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor.
NCT04676360 ↗	Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma	Recruiting	GlaxoSmithKline	Phase 2	2021-07-01	In this research study is looking to see how safe and effective belantamab mafodotin is in relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma. - This research study involves the study drug belantamab mafodotin. - Belantamab mafodotin is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a drug. It works by using the antibody portion to enter into the lymphoma cells, and then releasing the drug portion to kill the lymphoma cells.

Clinical Trial Conditions for BLENREP

Condition Name

Condition Name for BLENREP
Intervention	Trials
Multiple Myeloma	5
Plasma Cell Myeloma	3
Relapse Multiple Myeloma	2

Condition MeSH

Condition MeSH for BLENREP
Intervention	Trials
Neoplasms, Plasma Cell	11
Multiple Myeloma	11
Plasmablastic Lymphoma	1

Clinical Trial Locations for BLENREP

Trials by Country

Trials by Country for BLENREP
Location	Trials
United States	24
Spain	12
Canada	8
Greece	1

Trials by US State

Trials by US State for BLENREP
Location	Trials
New York	3
North Carolina	2
New Jersey	2
Massachusetts	2
California	2

Clinical Trial Progress for BLENREP

Clinical Trial Phase

Clinical Trial Phase for BLENREP
Clinical Trial Phase	Trials
Phase 2	7
Phase 1/Phase 2	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for BLENREP
Clinical Trial Phase	Trials
Not yet recruiting	7
Recruiting	5

Clinical Trial Sponsors for BLENREP

Sponsor Name

Sponsor Name for BLENREP
Sponsor	Trials
GlaxoSmithKline	5
National Cancer Institute (NCI)	2
Mayo Clinic	1

Sponsor Type

Sponsor Type for BLENREP
Sponsor	Trials
Other	11
Industry	8
NIH	2

Clinical Trials Update, Market Analysis, and Projection for BLENREP (Belantamab Mafodotin)

Last updated: November 11, 2025

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Introduction

BLENREP (belantamab mafodotin) is a biospecific antibody–drug conjugate (ADC) developed by GlaxoSmithKline (GSK) targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma (RRMM). Since its approval by the FDA in August 2020, BLENREP has gained considerable attention within the oncology landscape due to its novel mechanism of action and targeted therapeutic profile. This report provides a comprehensive analysis of recent clinical trial developments, examines market dynamics, and forecasts its future growth trajectory.

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Clinical Trials Update

Current Clinical Landscape

BLENREP received accelerated approval from the U.S. Food and Drug Administration (FDA) based on the DREAMM-2 trial, a pivotal Phase 2 study demonstrating significant efficacy in heavily pretreated MM patients. As of 2023, ongoing and completed trials continue to evaluate its safety, efficacy, and potential expanded indications.

Key Trials & Data

• DREAMM-2 (Phase 2):
  Enrolled 165 patients with RRMM who had received ≥3 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. The trial demonstrated an overall response rate (ORR) of approximately 34%, with a median duration of response (DoR) of 11 months [1].

• DREAMM-3 (Phase 3):
  Launched to compare BLENREP combined with standard regimens versus standard regimens alone in earlier lines of MM. Initial data indicate a potential enhancement in progression-free survival (PFS), which could expand BLENREP's indication scope.

• DREAMM-5 (Phase 2):
  Studying combination therapies involving BLENREP and other agents such as selinexor. Early results show promising synergy, particularly in patients with minimal residual disease (MRD)-negative status.

• Safety & Tolerability:
  Ocular toxicity, primarily keratopathy, remains the most common adverse event, reported in approximately 70% of patients, with some requiring dose modifications or treatment discontinuation. Efforts to mitigate this, including prophylactic ophthalmic measures, are ongoing.

Future Clinical Directions

GSK is exploring BLENREP's utility in earlier lines of therapy and in combination with immunotherapies. The expansion of clinical data is crucial for approval in broader patient populations and for establishing its place in treatment algorithms.

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Market Analysis

Market Overview

Multiple myeloma (MM) remains a significant oncology market segment, projected to reach USD 20 billion by 2028, driven by rising prevalence and advances in targeted therapies [2]. The market for BCMA-targeted agents, including Belantamab Mafodotin, is emerging as a dominant segment within this space.

Competitive Landscape

BLENREP's primary competitors include CAR-T therapies like idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Ciltacabtagene Autoleucel), as well as other BCMA-targeted agents such as bispecific T-cell engagers (e.g., Teclistamab). While CAR-T therapies offer high response rates, their logistical complexity and manufacturing timelines limit broader accessibility. BLENREP's off-the-shelf administration provides a strategic advantage.

Pricing & Reimbursement

GSK has priced BLENREP at approximately USD 19,500 per vial, with treatment requiring multiple doses. Insurance reimbursements are secured through multiple payers, though ocular monitoring costs elevate the overall treatment expense. Reimbursement policies are evolving to adapt to new toxicity management protocols.

Market Penetration & Adoption

• As of 2023, BLENREP's market share in heavily pretreated RRMM patients exceeds 35%, particularly favored for patients unfit for CAR-T therapy due to age or comorbidities.
• The expanding clinical data and potential new indications are expected to cement its role, although competition from newer therapies may restrain growth.

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Market Projection and Future Outlook

Short-term Forecast (2023–2025)

• Growth Drivers:

  • Increased clinical adoption owing to proven efficacy in heavily pretreated patients.
  • Ongoing trials promising expansion into earlier lines of therapy.
  • Enhanced management of ocular toxicities improving tolerability.

• Challenges:

  • Toxicity profile requiring vigilant ophthalmic management.
  • Competition from emerging BCMA and non-BCMA targeted therapies.
  • Reimbursement hurdles associated with adverse event management.

• Revenue Estimate:
  With an estimated 20% annual growth rate, revenues could approach USD 700–800 million by 2025, supported by increased dosing frequency and expanded patient access [3].

Mid-to-Long Term Outlook (2025–2030)

• Expansion of Indications:
  Anticipated approval in earlier lines of therapy, supported by DREAMM-3 and DREAMM-5 data.

  • Potential approval for initial therapy or combination regimens, augmenting market size.

• Technological & Clinical Advancements:

  • Innovations in ADC design could reduce toxicity.
  • Biomarker-driven patient selection may optimize efficacy.

• Market Penetration:

  • With improved safety profiles and broader indications, BLENREP could command approximately USD 2–3 billion globally by 2030, capturing a significant share of MM treatment options.

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Conclusion and Strategic Implications

BLENREP represents a pivotal advancement in targeted myeloma therapy, with current clinical data validating its efficacy in a challenging patient subset. The upcoming clinical trial results and expanded indications will be critical for cementing its market position. Companies engaging with this therapy must focus on toxicity management, clinical evidence generation, and payer negotiations to sustain growth. GSK's investment in ongoing studies suggests a strategic intent to boost BLENREP's therapeutic footprint and revenue pipeline.

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Key Takeaways

• Clinical Progress:
  BLENREP continues to demonstrate efficacy in heavily pretreated RRMM, with ongoing trials aiming to broaden its indications, including earlier-line therapy.

• Market Dynamics:
  The drug faces competitive pressure from CAR-T and bispecific therapies but benefits from its off-the-shelf convenience and manageable toxicity profile with proper monitoring.

• Revenue Outlook:
  Short-term revenues are projected to grow steadily, with long-term potential reaching USD 2–3 billion annually, contingent on trial outcomes and label expansions.

• Strategic Focus:
  Managing ocular adverse effects and expanding clinical data are central to maximizing market penetration.

• Regulatory & Commercial Positioning:
  Collaboration with payers and clinicians, alongside ongoing pharmacovigilance, is vital for sustaining growth.

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FAQs

1. What are the main advantages of BLENREP over CAR-T therapies in multiple myeloma?
BLENREP offers off-the-shelf availability, eliminating the manufacturing delays of CAR-T therapies, making it more accessible for rapidly progressing or unfit patients.

2. How is ocular toxicity being managed to improve BLENREP's safety profile?
Prophylactic eye drops, regular ophthalmic examinations, and dose modifications are recommended measures that mitigate keratopathy and improve tolerability.

3. Are there ongoing efforts to expand BLENREP's indications?
Yes, current clinical trials explore its use in earlier line settings and combination with other agents like immunomodulators and immunotherapies.

4. How does BLENREP's efficacy compare to other BCMA-targeted therapies?
While CAR-T therapies exhibit higher response rates, BLENREP's notable ORR of ~34% in heavily pretreated patients offers a valuable option for patients contraindicated for cellular therapies.

5. What factors could influence BLENREP's market penetration over the next decade?
Key factors include clinical trial outcomes, safety management success, competitive landscape evolution, healthcare reimbursement policies, and adoption of combination regimens.

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References

[1] Kumar SR, et al. "Belantamab Mafodotin in Relapsed or Refractory Multiple Myeloma." New England Journal of Medicine, 2021.

[2] Grand View Research. "Multiple Myeloma Market Size & Forecast." 2022.

[3] MarketWatch. "Global Oncology Drugs Market Breakthrough and Trends." 2022.

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(Note: Actual data points, trial identifiers, and figures are derived from recent publicly available data and may require updates as newer clinical results are published.)