CLINICAL TRIALS PROFILE FOR MONJUVI

All Clinical Trials for MONJUVI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05718869 ↗	Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study	Not yet recruiting	National Cancer Institute (NCI)	Phase 2	2023-07-15	This phase II trial tests how well tafasitamab and zanubrutinib works in treating patients with newly diagnosed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This may stop the growth and spread of cancer cells. Giving tafasitamab and zanubrutinib in combination may kill more cancer cells in patients with CLL/SLL than giving either treatment alone.
NCT05718869 ↗	Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study	Not yet recruiting	City of Hope Medical Center	Phase 2	2023-07-15	This phase II trial tests how well tafasitamab and zanubrutinib works in treating patients with newly diagnosed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This may stop the growth and spread of cancer cells. Giving tafasitamab and zanubrutinib in combination may kill more cancer cells in patients with CLL/SLL than giving either treatment alone.
NCT05453500 ↗	Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia	Not yet recruiting	Incyte Corporation	Phase 2	2023-01-01	This phase II clinical trial tests a chemotherapy regimen (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin with or without rituximab [DA-EPOCH+/-R]) with the addition of targeted therapy (tafasitamab) for the treatment of patients with newly diagnosed Philadelphia chromosome negative (Ph-) B acute lymphoblastic leukemia (B-ALL). Chemotherapy drugs, such as those in EPOCH+/-R, 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. Tafasitamab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Adding tafasitamab to the DA-EPOCH+/-R regimen may work better than DA-EPOCH+/-R alone in treating newly diagnosed Ph- B-ALL.
NCT05453500 ↗	Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia	Not yet recruiting	University of Washington	Phase 2	2023-01-01	This phase II clinical trial tests a chemotherapy regimen (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin with or without rituximab [DA-EPOCH+/-R]) with the addition of targeted therapy (tafasitamab) for the treatment of patients with newly diagnosed Philadelphia chromosome negative (Ph-) B acute lymphoblastic leukemia (B-ALL). Chemotherapy drugs, such as those in EPOCH+/-R, 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. Tafasitamab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Adding tafasitamab to the DA-EPOCH+/-R regimen may work better than DA-EPOCH+/-R alone in treating newly diagnosed Ph- B-ALL.
NCT04978584 ↗	Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study	Not yet recruiting	M.D. Anderson Cancer Center	Phase 2	2021-10-01	This phase II trial studies the effect of rituximab, lenalidomide, acalabrutinib, tafasitamab alone and in combination with chemotherapy in treating patients with newly diagnosed non-germinal center diffuse large B-cell lymphoma. Rituximab and tafasitamab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Acalabrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, cyclophosphamide, doxorubicin, and vincristine, and work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving rituximab, lenalidomide, acalabrutinib, tafasitamab alone and with combination chemotherapy may help control non-germinal center diffuse large B-cell lymphoma.
NCT04824092 ↗	Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients	Recruiting	MorphoSys AG	Phase 3	2021-05-11	This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Clinical Trial Conditions for MONJUVI

Condition Name

Condition Name for MONJUVI
Intervention	Trials
Chronic Lymphocytic Leukemia	2
Diffuse Large B-cell Lymphoma	2
Refractory B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma	1
Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma	1

Condition MeSH

Condition MeSH for MONJUVI
Intervention	Trials
Lymphoma	6
Lymphoma, B-Cell	4
Lymphoma, Large B-Cell, Diffuse	4
Leukemia, Lymphoid	3

Clinical Trial Locations for MONJUVI

Trials by Country

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−

Trials by Country for MONJUVI
Location	Trials
United States	39
Italy	1
New Zealand	1
Australia	1
Romania	1

Trials by US State

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−

Trials by US State for MONJUVI
Location	Trials
Minnesota	2
California	2
Washington	2
Texas	2
Oregon	2

Clinical Trial Progress for MONJUVI

Clinical Trial Phase

Clinical Trial Phase for MONJUVI
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	6
Phase 1	1

Clinical Trial Status

Clinical Trial Status for MONJUVI
Clinical Trial Phase	Trials
Not yet recruiting	6
Recruiting	2

Clinical Trial Sponsors for MONJUVI

Sponsor Name

Sponsor Name for MONJUVI
Sponsor	Trials
Incyte Corporation	3
National Cancer Institute (NCI)	3
Ipsen	1

Sponsor Type

Sponsor Type for MONJUVI
Sponsor	Trials
Other	8
Industry	6
NIH	3

MONJUVI: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to MONJUVI

MONJUVI, also known as tafasitamab-cxix, is a monoclonal antibody developed by MorphoSys and Incyte, designed to treat various types of lymphoma. Here, we will delve into the latest updates on its clinical trials, market performance, and future projections.

Clinical Trials Update

Approved Indication: Relapsed or Refractory DLBCL

MONJUVI was approved by the FDA in July 2020 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide. This approval was based on the Phase II L-MIND study, which showed an overall response rate of 55%, a complete response rate of 37%, and a partial response rate of 18%. The median duration of response was 21.7 months[2].

Ongoing Phase III Trials

inMIND Trial: Relapsed or Refractory Follicular Lymphoma

The inMIND trial, a Phase III study, has recently met its primary endpoint of progression-free survival (PFS) and key secondary endpoints in patients with relapsed or refractory follicular lymphoma (FL) treated with tafasitamab in combination with lenalidomide and rituximab. This positive data supports the planned U.S. filing of a supplemental Biologics License Application (sBLA) for tafasitamab in FL by the end of 2024[4].

frontMIND Trial: First-Line DLBCL

The frontMIND trial is evaluating tafasitamab plus lenalidomide and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP alone in previously untreated, high-intermediate, and high-risk patients with newly diagnosed DLBCL. This trial, involving over 800 patients, is expected to release primary analysis data in the second half of 2025[5].

B-MIND Trial: Relapsed or Refractory DLBCL

The B-MIND trial compares tafasitamab plus bendamustine to rituximab plus bendamustine in patients with relapsed or refractory DLBCL. This trial is part of MorphoSys' ongoing efforts to expand the indications for MONJUVI[5].

Market Analysis

Current Market Performance

In 2023, MONJUVI U.S. net product sales reached $92.0 million, with a gross margin of 69%. This performance was at the higher end of MorphoSys' financial guidance. The company anticipates Monjuvi U.S. net product sales to be in the range of $80 to $95 million for 2024, driven by potential growth from new indications currently under investigation[2].

Market Forecast

The market for MONJUVI is expected to evolve significantly due to extensive research and increasing healthcare spending globally. The drug's market forecast from 2023 to 2032 indicates a growing demand, particularly in the seven major markets: the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan. However, MONJUVI will face competition from emerging therapies for DLBCL, which could impact its market dominance[3].

Financial Guidance and Projections

2024 Financial Outlook

MorphoSys expects to maintain a strong financial position in 2024 by prioritizing areas that create immediate impact and value. The company anticipates R&D expenses to be lower in 2024 due to the full enrollment of Phase III studies and cost optimization measures. Selling, General, and Administrative (SG&A) expenses are expected to be in the range of €140 to €155 million, with Incyte reimbursing MorphoSys for half of these selling expenses[2].

Reduction in Financial Liability

MorphoSys has reduced its financial liability from the collaboration with Incyte by approximately €112 million, reflecting a more favorable financial position moving forward[2].

Clinical and Economic Impact

Patient Outcomes

The long-term overall survival (OS) data from the L-MIND study shows promising results, with 87% of second-line patients alive one year after treatment, declining to 49% after four years. The median OS stood at 45.7 months for second-line patients and 15.5 months for those undergoing third- and later-line treatment with MONJUVI. These data suggest a significant improvement in patient outcomes, potentially moving towards the goal of curing some patients with this previously fatal disease[5].

Economic Considerations

The economic impact of MONJUVI is substantial, given its potential to improve patient survival and quality of life. The drug's approval and ongoing trials are expected to drive healthcare spending in the lymphoma treatment market, contributing to the overall growth of the pharmaceutical sector.

Regulatory Milestones

FDA Approval and International Authorizations

MONJUVI received FDA approval in July 2020 and subsequent conditional marketing authorizations from Health Canada, the European Commission, and the MHRA in 2021. These approvals underscore the drug's efficacy and safety profile, paving the way for broader market access[3].

Upcoming Regulatory Filings

Incyte plans to submit a supplemental Biologics License Application (sBLA) for tafasitamab in follicular lymphoma by the end of 2024, based on the positive data from the inMIND trial. This filing will be crucial for expanding MONJUVI's indications and market reach[4].

Conclusion

MONJUVI has established itself as a significant treatment option for patients with relapsed or refractory DLBCL and is poised for further growth with ongoing and upcoming clinical trials. The drug's market performance is strong, and future projections indicate continued growth driven by new indications and expanding market access.

Key Takeaways

• Clinical Success: MONJUVI has met primary endpoints in several Phase III trials, including the inMIND trial for relapsed or refractory follicular lymphoma.
• Market Performance: 2023 sales reached $92.0 million, with a gross margin of 69%, and 2024 sales are projected to be between $80 to $95 million.
• Future Indications: Ongoing trials in first-line DLBCL and relapsed or refractory follicular and marginal zone lymphoma could expand MONJUVI's market.
• Regulatory Milestones: FDA approval and international authorizations have been secured, with upcoming sBLA filings planned.
• Economic Impact: MONJUVI is expected to contribute significantly to healthcare spending and patient outcomes in the lymphoma treatment market.

FAQs

What is MONJUVI used for?

MONJUVI (tafasitamab-cxix) is used for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide.

What were the key findings of the L-MIND study?

The L-MIND study showed an overall response rate of 55%, a complete response rate of 37%, and a partial response rate of 18%, with a median duration of response of 21.7 months[2].

What are the ongoing Phase III trials for MONJUVI?

Ongoing trials include the inMIND trial for relapsed or refractory follicular lymphoma, the frontMIND trial for first-line DLBCL, and the B-MIND trial for relapsed or refractory DLBCL[4][5].

What is the projected market performance of MONJUVI for 2024?

MorphoSys anticipates Monjuvi U.S. net product sales to be in the range of $80 to $95 million for 2024[2].

What are the regulatory milestones for MONJUVI?

MONJUVI received FDA approval in July 2020 and subsequent conditional marketing authorizations from Health Canada, the European Commission, and the MHRA in 2021. An sBLA filing for follicular lymphoma is planned for the end of 2024[3][4].

Sources

1. Applied Clinical Trials Online: "Monjuvi Succeeds in Phase III Trial of Patients with Relapsed or Refractory Follicular Lymphoma"[1].
2. BioSpace: "MorphoSys Reports Preliminary 2023 Monjuvi U.S. Net Product Sales and Gross Margin, Provides 2024 Financial Guidance, and Reduces Financial Liability"[2].
3. Business Wire: "MONJUVI (tafasitamab-cxix) Drug Insights and Market Forecasts - 2032"[3].
4. Incyte Investor Relations: "Incyte Late-Breaking Tafasitamab (Monjuvi®) Data at ASH 2024"[4].
5. GEN Edge: "Two by 2025: MorphoSys Consolidates Research, Retains Commercialization Goal"[5].