CLINICAL TRIALS PROFILE FOR POTELIGEO

All Clinical Trials for POTELIGEO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05996185 ↗	Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma	Not yet recruiting	Kyowa Kirin, Inc.	Phase 2	2024-06-01	Single- arm Phase II study evaluating the combination of mogamulizumab (MOGA) added on top of standard of care dose adjusted EPOCH (DA-EPOCH) in patients with newly diagnosed or relapsed/refractory (for CTCL only) aggressive T cell lymphoma including patients with Adult T-cell leukemia/lymphoma (ATLL).
NCT05996185 ↗	Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma	Not yet recruiting	Yale University	Phase 2	2024-06-01	Single- arm Phase II study evaluating the combination of mogamulizumab (MOGA) added on top of standard of care dose adjusted EPOCH (DA-EPOCH) in patients with newly diagnosed or relapsed/refractory (for CTCL only) aggressive T cell lymphoma including patients with Adult T-cell leukemia/lymphoma (ATLL).
NCT05956041 ↗	Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas	Recruiting	Hoosier Cancer Research Network	Phase 2	2023-12-06	This is an open-label, single-arm, multicenter, phase II study combining pembrolizumab and mogamulizumab in patients with advanced-stage, relapsed or refractory CTCL Each cycle will equal 6 weeks. Pembrolizumab will be administered on Day 1 of each cycle. Mogamulizumab will be administered on Day 1, 8, 15, and 22 of Cycle 1. For Cycle 2 and subsequent cycles, mogamulizumab will be administered on Day 1, 15 and 29 of each cycle. Subjects will undergo a response assessment prior to Cycle 3 and every 2 cycles thereafter. Subjects will continue study treatment until documented progression, unacceptable toxicity, or any other condition for discontinuation is met in protocol. A maximum of 2 years of study treatment may be administered. If a subject achieves a complete response (CR) per mSWAT criteria after 3 months of study treatment (2 cycles), they will continue study therapy for an additional 6 months (4 cycles). If a confirmed and persistent CR is met, they may discontinue study treatment and enter an observation period in protocol. Repeat disease evaluation is required prior to study therapy discontinuation. Subjects who progress during the observation period may be eligible for up to an additional 9 cycles (1 year) of pembrolizumab and mogamulizumab.
NCT05956041 ↗	Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas	Recruiting	Merck Sharp & Dohme LLC	Phase 2	2023-12-06	This is an open-label, single-arm, multicenter, phase II study combining pembrolizumab and mogamulizumab in patients with advanced-stage, relapsed or refractory CTCL Each cycle will equal 6 weeks. Pembrolizumab will be administered on Day 1 of each cycle. Mogamulizumab will be administered on Day 1, 8, 15, and 22 of Cycle 1. For Cycle 2 and subsequent cycles, mogamulizumab will be administered on Day 1, 15 and 29 of each cycle. Subjects will undergo a response assessment prior to Cycle 3 and every 2 cycles thereafter. Subjects will continue study treatment until documented progression, unacceptable toxicity, or any other condition for discontinuation is met in protocol. A maximum of 2 years of study treatment may be administered. If a subject achieves a complete response (CR) per mSWAT criteria after 3 months of study treatment (2 cycles), they will continue study therapy for an additional 6 months (4 cycles). If a confirmed and persistent CR is met, they may discontinue study treatment and enter an observation period in protocol. Repeat disease evaluation is required prior to study therapy discontinuation. Subjects who progress during the observation period may be eligible for up to an additional 9 cycles (1 year) of pembrolizumab and mogamulizumab.
NCT05956041 ↗	Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas	Recruiting	University of Michigan Rogel Cancer Center	Phase 2	2023-12-06	This is an open-label, single-arm, multicenter, phase II study combining pembrolizumab and mogamulizumab in patients with advanced-stage, relapsed or refractory CTCL Each cycle will equal 6 weeks. Pembrolizumab will be administered on Day 1 of each cycle. Mogamulizumab will be administered on Day 1, 8, 15, and 22 of Cycle 1. For Cycle 2 and subsequent cycles, mogamulizumab will be administered on Day 1, 15 and 29 of each cycle. Subjects will undergo a response assessment prior to Cycle 3 and every 2 cycles thereafter. Subjects will continue study treatment until documented progression, unacceptable toxicity, or any other condition for discontinuation is met in protocol. A maximum of 2 years of study treatment may be administered. If a subject achieves a complete response (CR) per mSWAT criteria after 3 months of study treatment (2 cycles), they will continue study therapy for an additional 6 months (4 cycles). If a confirmed and persistent CR is met, they may discontinue study treatment and enter an observation period in protocol. Repeat disease evaluation is required prior to study therapy discontinuation. Subjects who progress during the observation period may be eligible for up to an additional 9 cycles (1 year) of pembrolizumab and mogamulizumab.
NCT04848064 ↗	Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma	Recruiting	John Reneau	Phase 1	2021-11-01	This phase I trial is to find out the best dose, possible benefits and/or side effects of third-party natural killer cells in combination with mogamulizumab in treating patients with cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with third-party natural killer cells, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving third-party natural killer cells in combination with mogamulizumab may kill more cancer cells.

Clinical Trial Conditions for POTELIGEO

Condition Name

Condition Name for POTELIGEO
Intervention	Trials
Cutaneous T Cell Lymphoma	1
Fungoides Mycosis Sezary Syndrome	1
Recurrent Adult T-Cell Leukemia/Lymphoma	1
Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma	1

Condition MeSH

Condition MeSH for POTELIGEO
Intervention	Trials
Lymphoma	3
Lymphoma, T-Cell	3
Lymphoma, T-Cell, Peripheral	2
Lymphoma, T-Cell, Cutaneous	2

Clinical Trial Locations for POTELIGEO

Trials by Country

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−

Trials by Country for POTELIGEO
Location	Trials
United States	3

Trials by US State

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−

Trials by US State for POTELIGEO
Location	Trials
Connecticut	1
Michigan	1
Ohio	1

Clinical Trial Progress for POTELIGEO

Clinical Trial Phase

Clinical Trial Phase for POTELIGEO
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for POTELIGEO
Clinical Trial Phase	Trials
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for POTELIGEO

Sponsor Name

Sponsor Name for POTELIGEO
Sponsor	Trials
Kyowa Kirin, Inc.	1
Yale University	1
John Reneau	1

Sponsor Type

Sponsor Type for POTELIGEO
Sponsor	Trials
Other	4
Industry	2

POTELIGEO: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to POTELIGEO

POTELIGEO, also known as mogamulizumab-kpkc, is an immunotherapy drug approved for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), types of Cutaneous T-cell Lymphoma (CTCL). Here, we delve into the clinical trials, market analysis, and future projections for this significant therapeutic agent.

Clinical Trials and Efficacy

Trial Design and Participants

The FDA approval of POTELIGEO was based on a pivotal Phase III clinical trial (NCT01728805) that enrolled 372 patients with MF or SS who had received at least one prior systemic therapy. This open-label, multicentre, randomized trial compared POTELIGEO with vorinostat, a standard treatment for CTCL[1][5].

Efficacy Outcomes

The primary efficacy endpoint was investigator-assessed progression-free survival (PFS), which is the time from randomization until documented disease progression or death. Patients treated with POTELIGEO demonstrated a statistically significant improvement in PFS compared to those treated with vorinostat. The median PFS was 7.6 months for POTELIGEO versus 3.1 months for vorinostat, with a hazard ratio of 0.53 (95% CI: 0.41, 0.69)[1][5].

Overall Response Rate

The overall response rate (ORR) was another key efficacy endpoint. Patients treated with POTELIGEO showed a significantly higher ORR of 28% compared to 5% for those treated with vorinostat. This difference was consistent across various disease compartments, including skin, blood, lymph nodes, and viscera[1][5].

Time to Response and Duration of Response

Patients treated with POTELIGEO responded faster and had a longer duration of response compared to those on vorinostat. The median time to response in blood was 1.1 months and in skin was 3.0 months for POTELIGEO, which was approximately 2 months faster than vorinostat. The duration of response also lasted longer in patients taking POTELIGEO[4].

Dosage and Administration

POTELIGEO is administered intravenously (IV) by a healthcare provider. The dosing schedule involves infusions on days 1, 8, 15, and 22 of the first 28-day cycle, and on days 1 and 15 of each subsequent cycle. Each infusion takes about one hour to complete[1].

Market Analysis

Current Market Scenario

The market for POTELIGEO is part of the broader CTCL treatment landscape. Given its superior efficacy over vorinostat, POTELIGEO has established itself as a significant player in this market. The drug's approval and subsequent market performance have been influenced by its clinical trial outcomes and regulatory milestones[2].

Market Forecast

The market forecast for POTELIGEO indicates a promising future. The drug is expected to see increased adoption in the seven major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The forecasted sales data from 2023 to 2032 suggest a growing market size driven by incremental healthcare spending and extensive research in CTCL treatments[2].

Competitive Landscape

POTELIGEO faces competition from other emerging therapies for CTCL. However, its strong clinical efficacy data and established market presence position it favorably. The launch of late-stage emerging therapies is expected to impact the market, but POTELIGEO's current dominance is likely to continue due to its proven benefits[2].

Regulatory Milestones

FDA Approval

POTELIGEO was approved by the FDA based on the results of the Phase III clinical trial. The approval highlighted the drug's ability to improve PFS and ORR in patients with MF or SS who had received prior systemic therapy[1].

International Approvals

In addition to FDA approval, POTELIGEO has been approved in other regions, including Canada. The Summary Basis of Decision in Canada detailed the regulatory, safety, effectiveness, and quality evaluations that led to its approval[5].

Future Projections

Market Growth

The market for POTELIGEO is projected to grow significantly over the next decade. This growth will be driven by increasing awareness of CTCL, advancements in immunotherapy, and the drug's established efficacy. The forecasted sales data indicate a steady increase in market size across the major markets[2].

Research and Development

Ongoing research and development activities are expected to further enhance the therapeutic profile of POTELIGEO. This includes post hoc analyses and additional clinical trials that may explore new indications or combination therapies[3].

Emerging Therapies

While POTELIGEO remains a leading treatment for CTCL, the emergence of new therapies will continue to shape the market. The report highlights the importance of monitoring these developments to understand their potential impact on POTELIGEO's market share[2].

Key Takeaways

• Clinical Efficacy: POTELIGEO has demonstrated significant improvements in PFS and ORR compared to vorinostat in patients with MF or SS.
• Market Forecast: The drug is expected to see substantial market growth from 2023 to 2032, driven by its established efficacy and increasing healthcare spending.
• Regulatory Milestones: Approved by the FDA and other regulatory bodies, POTELIGEO has a strong regulatory foundation.
• Competitive Landscape: Despite emerging therapies, POTELIGEO's proven benefits position it favorably in the CTCL treatment market.
• Future Projections: Ongoing research and market growth are expected to further solidify POTELIGEO's place in the treatment of CTCL.

FAQs

What is POTELIGEO used for?

POTELIGEO is used for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), types of Cutaneous T-cell Lymphoma (CTCL), in patients who have received at least one prior systemic therapy[1].

How is POTELIGEO administered?

POTELIGEO is administered intravenously by a healthcare provider on specific days of a 28-day cycle[1].

What are the key benefits of POTELIGEO?

POTELIGEO offers improved progression-free survival (PFS) and overall response rate (ORR) compared to vorinostat, with faster response times and longer durations of response[1][4].

What is the market forecast for POTELIGEO?

The market for POTELIGEO is projected to grow significantly from 2023 to 2032, driven by its clinical efficacy and increasing healthcare spending[2].

Are there any emerging therapies that could impact POTELIGEO's market share?

Yes, the launch of late-stage emerging therapies for CTCL is expected to impact the market, but POTELIGEO's established benefits are likely to maintain its market position[2].

Sources

1. FDA: Drug Trials Snapshots: POTELIGEO - FDA
2. Research and Markets: POTELIGEO Drug Insight and Market Forecast - 2032
3. POTELIGEO HCP: POTELIGEO Overall Response Rate (ORR) vs. Vorinostat
4. POTELIGEO: Benefits of POTELIGEO® (mogamulizumab-kpkc)
5. Health Canada: Summary Basis of Decision for Poteligeo