CLINICAL TRIALS PROFILE FOR LEMTRADA

All Clinical Trials for LEMTRADA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00565773 ↗	Belatacept Post Depletional Repopulation to Facilitate Tolerance	Completed	Bristol-Myers Squibb	Phase 2	2007-12-01	Acute rejection is a common problem after a kidney transplant. Rejection can occur when the kidney recipient's immune system tries to attack (or reject) the new kidney. Rejection typically most often develops in the first few months after a transplant. This single center study will seek to determine if a new combination of anti-rejection medications, including the recently FDA approved drug called Belatacept, is better than the current standard anti-rejection drug regimen at preventing rejection. Also to be determined will be whether the new combination of drugs will allow participants to wean off their oral anti-rejection medications over time. This study will test the safety and effectiveness of a new investigational drug combination using alemtuzumab, belatacept, and sirolimus when given with or without donor bone marrow. This combination of medicines has not been tested before in humans. Alemtuzumab (Campath) is approved for use in some types of white blood cell cancers, but is considered investigational in transplant patients. Belatacept is now FDA approved and is being studied in transplant patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with belatacept and alemtuzumab is investigational. In the initial 20 subjects enrolled in the study, half tested whether an infusion of bone marrow from the kidney donor would improve the effect of these drugs. This bone marrow infusion was also considered investigational. Enrollment of 20 additional subjects began in January, 2013. The donor bone marrow infusion has been eliminated. Enrollment was open to primary living and deceased donor kidney recipients. Enrollment was closed as of 8/12/2014.
NCT00565773 ↗	Belatacept Post Depletional Repopulation to Facilitate Tolerance	Completed	Duke University	Phase 2	2007-12-01	Acute rejection is a common problem after a kidney transplant. Rejection can occur when the kidney recipient's immune system tries to attack (or reject) the new kidney. Rejection typically most often develops in the first few months after a transplant. This single center study will seek to determine if a new combination of anti-rejection medications, including the recently FDA approved drug called Belatacept, is better than the current standard anti-rejection drug regimen at preventing rejection. Also to be determined will be whether the new combination of drugs will allow participants to wean off their oral anti-rejection medications over time. This study will test the safety and effectiveness of a new investigational drug combination using alemtuzumab, belatacept, and sirolimus when given with or without donor bone marrow. This combination of medicines has not been tested before in humans. Alemtuzumab (Campath) is approved for use in some types of white blood cell cancers, but is considered investigational in transplant patients. Belatacept is now FDA approved and is being studied in transplant patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with belatacept and alemtuzumab is investigational. In the initial 20 subjects enrolled in the study, half tested whether an infusion of bone marrow from the kidney donor would improve the effect of these drugs. This bone marrow infusion was also considered investigational. Enrollment of 20 additional subjects began in January, 2013. The donor bone marrow infusion has been eliminated. Enrollment was open to primary living and deceased donor kidney recipients. Enrollment was closed as of 8/12/2014.
NCT00230282 ↗	Phase 2 Fludarabine, Cytoxan and FCCAM in Untreated B-Cell Chronic Lymphocytic Leukemia	Completed	Bayer	Phase 2	2004-07-01	The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.
NCT00230282 ↗	Phase 2 Fludarabine, Cytoxan and FCCAM in Untreated B-Cell Chronic Lymphocytic Leukemia	Completed	Steven E. Coutre	Phase 2	2004-07-01	The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.

Clinical Trial Conditions for LEMTRADA

Condition Name

Condition Name for LEMTRADA
Intervention	Trials
Multiple Sclerosis	4
Sickle Cell Disease	3
Leukemia	2
Immunodeficiencies	1

Condition MeSH

Condition MeSH for LEMTRADA
Intervention	Trials
Multiple Sclerosis	8
Sclerosis	7
Multiple Sclerosis, Relapsing-Remitting	4
Anemia, Sickle Cell	3

Clinical Trial Locations for LEMTRADA

Trials by Country

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−

Trials by Country for LEMTRADA
Location	Trials
United States	89
Canada	4
Poland	4
Netherlands	4
Belgium	3

Trials by US State

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−

Trials by US State for LEMTRADA
Location	Trials
Illinois	6
New York	6
California	5
Ohio	4
North Carolina	4

Clinical Trial Progress for LEMTRADA

Clinical Trial Phase

Clinical Trial Phase for LEMTRADA
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for LEMTRADA
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	4
Recruiting	3

Clinical Trial Sponsors for LEMTRADA

Sponsor Name

Sponsor Name for LEMTRADA
Sponsor	Trials
Genzyme, a Sanofi Company	6
National Cancer Institute (NCI)	3
Emory University	2

Sponsor Type

Sponsor Type for LEMTRADA
Sponsor	Trials
Other	21
Industry	8
NIH	4

LEMTRADA (Alemtuzumab): Clinical Trials, Market Analysis, and Projections

Introduction to LEMTRADA

LEMTRADA (alemtuzumab) is a biologic drug developed by Sanofi and Genzyme, primarily used for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Study Design and Participants

LEMTRADA was studied in two 2-year clinical trials, CARE-MS I and CARE-MS II, comparing it against Rebif (interferon beta-1a) 44 mcg. These trials included patients who had experienced at least two relapses in the two years prior to the trial and at least one relapse in the year prior. Participants had to have relapsed on interferon beta or glatiramer acetate and had Expanded Disability Status Scale (EDSS) scores of 5 or less[1][4].

Key Outcomes

• Relapse Rates: LEMTRADA demonstrated a lower annual relapse rate of 0.26 compared to 0.52 for Rebif. This significant reduction in relapse rates highlights the drug's efficacy in managing RRMS[2].
• Disability Progression: Only 13% of patients treated with LEMTRADA experienced confirmed disability progression, whereas 21% of those treated with Rebif did so. This indicates that LEMTRADA is effective in slowing disability progression[2].
• Long-Term Effects: In the extension study, 68% and 60% of LEMTRADA-treated patients from CARE-MS I and II, respectively, did not receive additional LEMTRADA treatment during the following four years and still maintained the treatment effects. This suggests sustained efficacy over an extended period[4].

Safety Profile

While LEMTRADA has shown significant clinical efficacy, it is associated with serious side effects, including infusion reactions, autoimmune disorders such as thyroid disease, and autoimmune thrombocytopenia. Patients must be monitored for complete blood counts, serum creatinine levels, and urinalysis for 48 months after the last dose[4].

Market Analysis

Sales Performance

The sales of LEMTRADA have been influenced by several factors:

• COVID-19 Impact: The COVID-19 pandemic led to a significant decline in LEMTRADA sales, with a 60.3% decrease in the fourth quarter of 2020 and a 58.7% decrease for the full year 2020. This decline was due to disruptions in healthcare services and patient access to treatments[2].
• Geographic Sales: LEMTRADA's performance varies across different regions. Key markets include the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China, and India. However, actual sales have been affected by regional competition and healthcare policies[2].

Competitive Landscape

The MS treatment market is highly competitive, with several drugs vying for market share. LEMTRADA competes with other biologics and disease-modifying therapies, including Rebif and newer entrants. This competition has impacted LEMTRADA's sales and market position[2].

Regulatory and Development Updates

Regulatory Approvals

LEMTRADA's development and regulatory status have been crucial for its market dynamics. The drug has undergone extensive clinical trials, and its efficacy has been established. However, regulatory approvals and market access have been influenced by various factors, including the withdrawal of Campath from the US and EU markets to focus on MS treatment[2].

Future Development

Sanofi and Genzyme are focusing on R&D to enhance LEMTRADA's profile. They are managing expenses and reinvesting savings into growth drivers, including leveraging AI to unlock the full potential of their pipeline. LEMTRADA is also under development for the treatment of RRMS in pediatric patients and is being explored for primary progressive multiple sclerosis (PPMS)[2][5].

Patient Outcomes and Long-Term Studies

Long-Term Efficacy

Long-term studies have shown that patients treated with LEMTRADA have a higher likelihood of remaining relapse-free compared to those treated with Rebif. At the end of a 6-year study, 77% of patients who took LEMTRADA had stabilized or improved disability, indicating positive long-term outcomes[2].

Extension Studies

In the extension of the Phase III pivotal studies, the effects observed in the two-year trials were maintained through three additional years. This consistency across relapse, disability, brain atrophy, and MRI lesion activity underscores the sustained efficacy of LEMTRADA[4].

Market Strategies and Future Outlook

Market Strategies

Sanofi and Genzyme have employed several strategies to optimize LEMTRADA's market performance, including focusing on R&D, managing expenses, and reinvesting savings into growth drivers. These strategies aim to enhance the drug's profile and improve its market position despite current challenges[2].

Future Projections

Despite the impact of the COVID-19 pandemic and market competition, LEMTRADA is expected to generate significant revenue in key markets. The drug's sustained efficacy and long-term benefits are likely to maintain its position in the MS treatment market. However, ongoing R&D and strategic investments will be crucial for its future success[2].

Key Takeaways

• Clinical Efficacy: LEMTRADA reduces relapses and slows disability progression in RRMS patients.
• Market Impact: COVID-19 significantly reduced LEMTRADA sales in 2020.
• Competitive Landscape: Intense competition in the MS treatment market affects LEMTRADA's sales.
• Regulatory and Development: Ongoing R&D and regulatory approvals are crucial for LEMTRADA's market performance.
• Long-Term Outcomes: Patients treated with LEMTRADA show better long-term disability outcomes.

FAQs

Q: What is LEMTRADA used for? A: LEMTRADA (alemtuzumab) is used for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)[2].

Q: How does LEMTRADA compare to Rebif in clinical trials? A: LEMTRADA showed a lower annual relapse rate and reduced disability progression compared to Rebif in clinical trials[2].

Q: What was the impact of the COVID-19 pandemic on LEMTRADA sales? A: The COVID-19 pandemic led to a significant decline in LEMTRADA sales, with a 60.3% decrease in the fourth quarter of 2020[2].

Q: Which regions are key markets for LEMTRADA? A: The key markets include the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China, and India[2].

Q: What are the future outlook and strategies for LEMTRADA? A: Sanofi and Genzyme are focusing on R&D, managing expenses, and reinvesting savings into growth drivers to enhance LEMTRADA's profile and market position[2].

Sources

1. LEMTRADA® (alemtuzumab) Clinical Study Results - LEMTRADA.
2. LEMTRADA Drug Profile - DrugPatentWatch.
3. Treatment Effects Maintained over Seven Years in Patients with Relapsing-Remitting Multiple Sclerosis - Sanofi Press Room.
4. Treatment effects maintained over 5 years in patients with RRMS who received Genzyme’s Lemtrada® (alemtuzumab) in Clinical Trials - MS Care.
5. Lemtrada in Primary Progressive Multiple Sclerosis (PPMS) - Market Analysis - GlobalData.