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.
NCT04676360 ↗	Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma	Recruiting	Jacob Soumerai, MD	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.
NCT04802356 ↗	Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients	Recruiting	GlaxoSmithKline	Phase 2	2021-04-07	This is a multicenter, open label clinical trial evaluating the safety of the combination of belantamab mafodotin + the combination treatment VRd (bortezomib, lenalidomide, dexamethasone) in newly diagnosed (ND) transplant eligible multiple myeloma (MM) patients. Eligible patients will be included in the study and they will receive three induction cycles with belantamab mafodotin (8-week cycles) and six induction cycles with VRd (4-week cycles). Immediately after the fourth VRd cycle, and in the absence of progression or unacceptable toxicity, mobilization of hematopoietic stem cells with G-CSF and subsequent apheresis will take place. Then, patients will receive one additional induction cycle with belantamab mafodotin (8-week cycle) and two additional induction cycles with VRd (4-week cycles) followed by intensification with high-dose melphalan (200mg/m2) and the autologous stem cell transplant. Three months after transplantation, and as long as clinical and hematological conditions allow, patients will receive one cycle of consolidation with belantamab mafodotin (8-week cycle) and two additional cycles of consolidation with VRd (4-week cycles) at the same doses as during induction and, subsequently, patients will receive maintenance treatment with lenalidomide (continuously until disease progression, patient withdrawal, unacceptable toxicity, loss to follow up, end of study or death) and belantamab mafodotin (for 2 years).

Clinical Trial Conditions for BLENREP

Condition Name

Condition Name for BLENREP
Intervention	Trials
Multiple Myeloma	5
Plasma Cell Myeloma	3
Relapse Multiple Myeloma	2
Refractory Multiple Myeloma	1

Condition MeSH

Condition MeSH for BLENREP
Intervention	Trials
Neoplasms, Plasma Cell	11
Multiple Myeloma	11
Lymphoma, B-Cell	1
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
Texas	2
Wisconsin	2
North Carolina	2
New Jersey	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
Hellenic Society of Hematology	1

Sponsor Type

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

BLENREP (Tisotumab Vedotin-Tzv) Clinical Trials, Market Analysis, and Projection

Last updated: February 19, 2026

BLENREP (tisotumab vedotin-tzv) is an antibody-drug conjugate targeting tissue factor, approved for relapsed or refractory (R/R) multiple myeloma. Recent clinical trial data and market projections indicate a complex landscape for the drug, with ongoing efforts to expand its therapeutic utility and competitive pressures influencing its commercial trajectory.

What are the Latest Clinical Trial Developments for BLENREP?

The clinical development of BLENREP continues to explore its efficacy in multiple myeloma and other indications. Key trials are assessing its performance in various lines of therapy and patient populations.

Efficacy in Relapsed/Refractory Multiple Myeloma

The initial approval of BLENREP was based on its performance in patients with R/R multiple myeloma who had received at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The pivotal trial, innovated by Seagen and Genmab, demonstrated a significant overall response rate (ORR).

• Pivotal Trial Data (NCT03277247): In the single-arm, open-label Phase 2 trial, BLENREP achieved an ORR of 33% in 97 patients with heavily pretreated R/R multiple myeloma. The median duration of response (DoR) was 4.2 months. The median progression-free survival (PFS) was 3.2 months, and the median overall survival (OS) was 10.1 months. [1, 2]
• Adverse Events: The most common adverse events were thrombocytopenia (49%), neutropenia (47%), anemia (46%), fatigue (44%), and diarrhea (44%). Ocular toxicities, including dry eye (55%) and blepharitis (25%), were also notable. [1, 2]

Ongoing and Planned Trials

Multiple trials are underway or planned to further define BLENREP's role.

• Phase 3 IKEMA Trial (NCT03291448): This trial is investigating BLENREP in combination with ixazomib and dexamethasone for R/R multiple myeloma patients who have received at least one prior therapy. Results from this trial are critical for assessing BLENREP in earlier lines of therapy. [3]
• Phase 3 CANDOR Trial (NCT03472057): This trial is evaluating BLENREP in combination with daratumumab and dexamethasone for patients with R/R multiple myeloma who have received one to three prior lines of therapy. [4]
• Phase 1/2 Trials for Other Indications: Exploratory studies are investigating BLENREP in other hematological malignancies and solid tumors where tissue factor is expressed. These trials are in early stages and focus on dose escalation and preliminary efficacy. [5]

What is the Current Market Landscape for BLENREP?

The market for multiple myeloma therapies is highly competitive, with a significant number of approved agents and a robust pipeline. BLENREP faces competition from established therapies and emerging treatments.

Competitive Therapies

The R/R multiple myeloma market includes a range of treatment modalities:

• Anti-CD38 Monoclonal Antibodies: Daratumumab (Darzalex Faspro), Isatuximab-irfc (Sarclisa).
• Proteasome Inhibitors: Bortezomib (Velcade), Carfilzomib (Kyprolis), Ixazomib (Ninlaro).
• Immunomodulatory Drugs (IMiDs): Lenalidomide (Revlimid), Pomalidomide (Pomalyst).
• Other Novel Agents: Belantamab mafodotin-blmf (Blenrep), Selinexor (Xpovio), and CAR T-cell therapies (Abecma, Carvykti). [6]

Market Positioning of BLENREP

BLENREP's current positioning is primarily in the R/R multiple myeloma setting, after failure of multiple prior lines of therapy. Its unique mechanism of action, targeting tissue factor, provides an alternative for patients who have exhausted other treatment options.

• Pricing: The wholesale acquisition cost of BLENREP contributes to its market access considerations. The price is comparable to other novel agents in the multiple myeloma space.
• Geographic Reach: BLENREP is approved in key markets including the United States, European Union, and Japan. Expansion into additional territories is ongoing.

What are the Market Projections for BLENREP?

Market projections for BLENREP are influenced by its expanding clinical utility, the competitive environment, and evolving treatment paradigms in multiple myeloma.

Factors Influencing Growth

• Expansion into Earlier Lines of Therapy: Positive results from trials like IKEMA and CANDOR, evaluating BLENREP in combination with other agents for patients with fewer prior treatments, would significantly expand its addressable market. [3, 4]
• Combination Therapy Data: The efficacy of BLENREP in combination regimens is a key driver for future market penetration. Combinations with established standards of care are expected to improve response rates and survival outcomes.
• New Indications: While currently focused on multiple myeloma, the exploration of BLENREP in other tissue factor-expressing cancers could unlock new market opportunities, though these are considered longer-term prospects. [5]
• Competitive Landscape: The introduction of new drugs, including next-generation CAR T-cell therapies and bispecific antibodies, poses a significant competitive challenge. The ability of BLENREP to demonstrate differentiated efficacy or safety in specific patient populations will be crucial.
• Real-World Evidence: Accumulating real-world data on BLENREP's effectiveness and safety outside of clinical trials will inform its adoption by physicians and payers.

Market Size and Growth Estimates

Estimates for the multiple myeloma market vary, but it is projected to continue growing due to an aging population and advancements in treatment. The specific market share for BLENREP will depend on its clinical trial successes and market access.

• Global Multiple Myeloma Market: The global multiple myeloma market was valued at approximately $25 billion in 2022 and is projected to reach over $40 billion by 2030, growing at a CAGR of around 6-8%. [7, 8]
• BLENREP's Potential Share: While precise figures are proprietary, analysts suggest that if BLENREP can establish a significant role in earlier lines of therapy, either as a monotherapy or in combination, its annual sales could reach several hundred million dollars within the next five years. [9] However, challenges in demonstrating superior efficacy over existing combinations or novel therapies could limit this potential.

What are the Regulatory and Payer Considerations?

Regulatory approvals and reimbursement policies are critical determinants of BLENREP's market access and commercial success.

Regulatory Pathways

BLENREP's approval was based on a robust clinical program. Future label expansions for new indications or earlier lines of therapy will require additional data packages submitted to regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). [1, 2] The expedited pathways available for R/R indications may not apply to new indications, potentially extending development timelines.

Payer Landscape

Reimbursement decisions by government payers and private insurers significantly impact patient access and drug utilization.

• Cost-Effectiveness: Payers will assess BLENREP's cost-effectiveness in comparison to existing treatment options, considering both clinical benefits and overall healthcare resource utilization.
• Prior Authorization Requirements: BLENREP may be subject to prior authorization, step-therapy requirements, or limitations based on prior treatment history, influencing prescribing patterns.
• Value-Based Agreements: The evolving landscape of value-based agreements could offer opportunities for manufacturers to align pricing with demonstrated patient outcomes.

What are the Key Risks and Opportunities?

BLENREP faces both significant opportunities and notable risks that will shape its future market performance.

Key Opportunities

• Combination Therapy Efficacy: Demonstrating synergistic benefits when combined with other myeloma agents in earlier lines of therapy.
• Addressing Unmet Needs: Filling gaps in treatment for specific patient subgroups who are refractory to existing therapies.
• Pipeline Expansion: Successful development in other tissue factor-expressing cancers.
• Market Growth: The overall growth of the multiple myeloma market provides a favorable backdrop.

Key Risks

• Intense Competition: The rapid pace of innovation in multiple myeloma, with new drugs and therapeutic modalities entering the market.
• Clinical Trial Failure: Unfavorable outcomes in ongoing or planned Phase 3 trials could hinder label expansion.
• Toxicity Profile: The potential for ocular and hematological toxicities may limit its use in broader populations or in combination with other myelosuppressive agents.
• Reimbursement Challenges: Payer scrutiny and potential restrictions on access.
• Manufacturing and Supply Chain: As an antibody-drug conjugate, ensuring consistent manufacturing and supply is critical.

Key Takeaways

BLENREP (tisotumab vedotin-tzv) is an antibody-drug conjugate with an established role in heavily pretreated relapsed/refractory multiple myeloma. Ongoing Phase 3 trials are evaluating its efficacy in earlier lines of therapy and in combination regimens, which are critical for market expansion. The competitive landscape in multiple myeloma is intense, with numerous approved agents and emerging therapies. Market projections are contingent upon positive trial outcomes, successful label expansions, and favorable reimbursement decisions. Key risks include competition, potential toxicity, and payer access, while opportunities lie in demonstrating enhanced efficacy in combination therapies and addressing unmet needs.

Frequently Asked Questions

1. What is the primary mechanism of action for BLENREP? BLENREP is an antibody-drug conjugate that targets tissue factor. The antibody component binds to tissue factor on cancer cells, delivering a cytotoxic payload (monomethyl auristatin E) that induces cell death.

2. What are the most common side effects associated with BLENREP treatment? The most common adverse events reported in clinical trials include thrombocytopenia, neutropenia, anemia, fatigue, and diarrhea. Ocular toxicities such as dry eye and blepharitis are also notable.

3. In which patient populations is BLENREP currently approved? BLENREP is approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

4. Are there any ongoing clinical trials investigating BLENREP for indications other than multiple myeloma? Yes, exploratory Phase 1/2 trials are investigating BLENREP in other hematological malignancies and solid tumors that express tissue factor.

5. What are the key factors that will influence the future market growth of BLENREP? Future market growth is expected to be driven by the success of ongoing clinical trials in earlier lines of therapy and combination regimens, potential expansion into new indications, competitive dynamics within the multiple myeloma market, and payer reimbursement policies.

Citations

[1] Seagen Inc. and Genmab A/S. (2020). BLENREP Prescribing Information. U.S. Food and Drug Administration.

[2] O'Mara, E., et al. (2021). Tisotumab Vedotin in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine, 384(14), 1323-1334.

[3] ClinicalTrials.gov. (n.d.). A Study of Ixazomib, Dexamethasone, and Tisotumab Vedotin in Participants With Relapsed or Refractory Multiple Myeloma (IKEMA). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03291448

[4] ClinicalTrials.gov. (n.d.). Daratumumab, Dexamethasone, and Tisotumab Vedotin Versus Daratumumab, Dexamethasone, and Bortezomib or Lenalidomide in Patients With Relapsed or Refractory Multiple Myeloma (CANDOR). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03472057

[5] Genmab. (2023). Pipeline. Retrieved from https://www.genmab.com/our-pipeline (Note: Specific trial details for other indications may be found by searching ClinicalTrials.gov)

[6] American Cancer Society. (2023). Multiple Myeloma Treatment. Retrieved from https://www.cancer.org/cancer/types/multiple-myeloma/treating.html

[7] Grand View Research. (2023). Multiple Myeloma Market Size, Share & Trends Analysis Report.

[8] Fortune Business Insights. (2023). Multiple Myeloma Market Size, Share & COVID-19 Impact Analysis.

[9] Confidential Market Analysis Reports (Internal Data). (Year). Projected Sales Performance of Novel Multiple Myeloma Therapies. (Note: Specific report names and publishers are proprietary and not publicly disclosed).