CLINICAL TRIALS PROFILE FOR BLINCYTO

All Clinical Trials for BLINCYTO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01371630 ↗	Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2011-08-26	This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating older patients with previously untreated acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
NCT01371630 ↗	Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia	Recruiting	Pfizer	Phase 1/Phase 2	2011-08-26	This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating older patients with previously untreated acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
NCT01371630 ↗	Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia	Recruiting	M.D. Anderson Cancer Center	Phase 1/Phase 2	2011-08-26	This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating older patients with previously untreated acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
NCT02003222 ↗	Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia	Active, not recruiting	Canadian Cancer Trials Group	Phase 3	2013-12-23	This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
NCT02003222 ↗	Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2013-12-23	This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
NCT02101853 ↗	Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2014-12-08	This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.
NCT02143414 ↗	Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2015-01-12	This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.

Clinical Trial Conditions for BLINCYTO

Condition Name

Condition Name for BLINCYTO
Intervention	Trials
Acute Lymphoblastic Leukemia	12
B Acute Lymphoblastic Leukemia	5
Refractory Acute Lymphoblastic Leukemia	3
Philadelphia Chromosome Positive	3

Condition MeSH

Condition MeSH for BLINCYTO
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	32
Leukemia, Lymphoid	30
Leukemia	29
Lymphoma	11

Clinical Trial Locations for BLINCYTO

Trials by Country

Trials by Country for BLINCYTO
Location	Trials
United States	298
Canada	26
Australia	20
Spain	17
Germany	10

Trials by US State

Trials by US State for BLINCYTO
Location	Trials
California	15
Texas	15
South Carolina	10
Ohio	10
Maryland	10

Clinical Trial Progress for BLINCYTO

Clinical Trial Phase

Clinical Trial Phase for BLINCYTO
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	1
Phase 3	7

Clinical Trial Status

Clinical Trial Status for BLINCYTO
Clinical Trial Phase	Trials
Recruiting	24
Active, not recruiting	8
Withdrawn	3

Clinical Trial Sponsors for BLINCYTO

Sponsor Name

Sponsor Name for BLINCYTO
Sponsor	Trials
Amgen	20
National Cancer Institute (NCI)	14
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for BLINCYTO
Sponsor	Trials
Other	51
Industry	32
NIH	14

Clinical Trials Update, Market Analysis, and Projection for BLINCYTO (Blinatumomab)

Last updated: October 29, 2025

Introduction

Blinatumomab, marketed as BLINCYTO, is a bispecific T-cell engager (BiTE) antibody developed by Amgen, approved for treating certain types of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Since its FDA approval in December 2014, BLINCYTO has transformed the therapeutic landscape for hematologic malignancies. This report provides a comprehensive update on its ongoing clinical trials, evaluates market dynamics, and offers projections based on emerging data and industry trends.

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Clinical Trials Update

Regulatory Status and Ongoing Trials

Since its initial approval, BLINCYTO has undergone multiple clinical trials to expand its indications, optimize dosing, and improve safety profiles. As of 2023, the drug is approved for:

• Relapsed or refractory B-cell precursor ALL in pediatric and adult populations.
• Minimal residual disease (MRD) positivity in adult ALL patients.

Trials for New Indications

Amgen continues to explore BLINCYTO’s utility beyond ALL:

• Relapsed Non-Hodgkin Lymphoma (NHL): Multiple phase II/III trials evaluate efficacy in diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma.
• Combination Therapies: Studies assessing BLINCYTO with immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors) are underway to enhance immune response.
• Earlier-Stage Disease: Trials targeting newly diagnosed B-ALL populations to assess the potential for frontline therapy.

Trial Outcomes and Published Data

Recent trials have demonstrated promising efficacy:

• TOWER Trial (NCT02595866): A phase III trial comparing BLINCYTO to chemotherapy showed superior complete remission (CR) rates and median overall survival (OS) in relapsed/refractory ALL.
• MRD-positive Trials: Achieved deep molecular remissions with minimal residual disease negativity, indicating potential for durable responses.
• Safety Profile: CRS (cytokine release syndrome) and neurotoxicity remain the primary adverse events; advancements in premedication and dose adjustment have improved tolerability.

Future Trial Directions

Amgen is actively recruiting for:

• Frontline Use: Trials assessing BLINCYTO as a first-line agent combined with chemotherapy in newly diagnosed patients.
• Pediatric Population: Efforts to expand pediatric indications are ongoing, with emphasis on long-term safety and efficacy.
• Real-world Data Collection: Post-marketing registries to evaluate effectiveness outside controlled trials.

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Market Analysis

Market Size and Segments

The global hematologic malignancy therapeutics market is projected to grow at a CAGR of approximately 7% through 2030, driven by rising incidence rates and targeted therapies such as BLINCYTO ([1]).

Key segments include:

• Relapsed/Refractory (R/R) ALL: The primary market where BLINCYTO is already approved.
• MRD-positive Patients: Growing recognition of minimal residual disease status influences treatment choices.
• Combination Regimens: Potential expansion into combination therapies broadens the market scope.

Competitive Landscape

BLINCYTO faces competition from other immunotherapies, including CAR T-cell treatments like Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel).

Product	Mechanism	Indications	Strengths	Challenges
BLINCYTO	Bispecific T-cell engager	R/R ALL, MRD-positive	Off-the-shelf, fixed dosing	Cytokine release syndrome, neurotoxicity
Kymriah	CAR T-cell therapy	R/R ALL, NHL	Durable remissions	Manufacturing complex, cost
Yescarta	CAR T-cell therapy	R/R NHL	Long-term efficacy	Similar safety concerns

Despite competition, BLINCYTO's off-the-shelf administration and manageable safety profile position it favorably.

Pricing and Revenue Trends

• Pricing: Approximately $178,000 per treatment course (as per 2021 data).
• Reimbursement: Covered under Medicare and private insurance, facilitating access.
• Revenue: In 2022, Amgen reported approximately $400 million in BLINCYTO sales, with growth driven by expanding indications and geographic reach.

Regional Market Dynamics

• North America: Dominates due to high diagnosis rates, robust healthcare infrastructure, and early adoption.
• Europe: Growing acceptance, with regulatory approvals in several countries; pending EMA review.
• Asia-Pacific: Emerging markets with increasing hematologic malignancy incidence and expanding healthcare investments.

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Market Projections

Short to Mid-Term (Next 3–5 Years)

• Market Penetration: With ongoing trials demonstrating efficacy in frontline settings and new indications, BLINCYTO’s addressable market could expand by approximately 30-50%.
• Revenue Growth: Expected CAGR of 12-15%, driven by pipeline success, greater adoption in earlier disease stages, and geographic expansion.
• Regulatory Milestones: Anticipated approvals in NHL subtypes and pediatric populations will further boost sales.

Long-Term Outlook (Next 5–10 Years)

• Market Share: BLINCYTO could capture 25-30% of the hematologic immunotherapy market for B-cell malignancies, competing closely with CAR T therapies.
• Innovation Impact: Development of next-generation bispecific antibodies and combination regimens may augment or supersede BLINCYTO’s position.
• Biosimilars: Pending patent expirations, biosimilar entry could influence pricing and market share, although Amgen’s patent protections and technological barriers may delay biosimilar competitiveness.

Key Factors Influencing Market Dynamics

• Advances in immunotherapy: Improved outcomes from combination therapies.
• Safety Optimization: Managing and reducing adverse events broadens patient eligibility.
• Regulatory Support: Accelerated approvals for new indications accelerate market expansion.
• Healthcare Access: Strategies to improve affordability and reimbursement will be crucial, especially in emerging markets.

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Conclusion

BLINCYTO remains a critical agent in treating relapsed or refractory B-cell ALL, with ongoing clinical trials poised to extend its utility into earlier lines of therapy and other hematological malignancies. Its innovative bispecific antibody mechanism, coupled with a manageable safety profile and expanding indications, sustains its market relevance.

With robust growth projections and a competitive landscape increasingly shaped by emerging immunotherapies, BLINCYTO's strategic positioning—especially with improvements in safety and combination strategies—suggests sustained financial performance. Regulatory progress, pipeline success, and global access initiatives will determine its future trajectory in this dynamic space.

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Key Takeaways

• Clinical Advancements: BLINCYTO is demonstrating promising efficacy in clinical trials for new indications, including frontline and pediatric treatments.
• Market Position: Dominates the off-the-shelf bispecific antibody market for hematologic malignancies, with competitive advantages over CAR T-cell therapies in certain areas.
• Growth Drivers: Pipeline expansion, geographic penetration, and improved safety profiles will fuel growth through 2030.
• Challenges: Competition from CAR T therapies, price pressures, and biosimilar entries are potential hurdles.
• Strategic Outlook: Continued clinical development and global access initiatives are essential to capitalize on emerging opportunities.

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FAQs

1. What are the primary approved indications for BLINCYTO?
BLINCYTO is FDA-approved for adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), including MRD-positive cases.

2. How does BLINCYTO compare to CAR T-cell therapies?
BLINCYTO offers an off-the-shelf option with easier administration, whereas CAR T-cell therapies are personalized, involving complex manufacturing, longer delays, and higher costs. Both have comparable efficacy but differ in safety profiles, logistics, and suitability.

3. What is the safety profile of BLINCYTO?
CRS and neurotoxicity are the leading adverse events, manageable with premedication, dose adjustments, and supportive care. Safety improvements continue through trial data and clinical experience.

4. Are there ongoing trials to expand BLINCYTO’s indications?
Yes. Amgen is investigating BLINCYTO in NHL, combination strategies with checkpoint inhibitors, and as a frontline therapy for newly diagnosed patients.

5. What is the market outlook for BLINCYTO over the next decade?
The market is projected to grow at a double-digit CAGR, driven by pipeline successes, new indications, expanded geographic reach, and evolving treatment paradigms, maintaining its relevance amid competition.

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References

[1] Global Hematologic Malignancies Market Report, 2022–2030.