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CLINICAL TRIALS PROFILE FOR LENVIMA

All Clinical Trials for lenvima

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02430714 ↗	Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)	Completed	Eisai Co., Ltd.		2015-05-20	This study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. The objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic event, and liver disorder.
NCT02501096 ↗	Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors	Active, not recruiting	Merck Sharp & Dohme Corp.	Phase 1/Phase 2	2015-07-22	This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in participants with selected solid tumors. Phase 1b will determine and confirm the maximum tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous [IV], every 3 weeks [Q3W]) pembrolizumab in participants with selected solid tumors (i.e. non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma). Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 6 cohorts at the MTD from Phase 1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).
NCT02501096 ↗	Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors	Active, not recruiting	Eisai Inc.	Phase 1/Phase 2	2015-07-22	This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in participants with selected solid tumors. Phase 1b will determine and confirm the maximum tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous [IV], every 3 weeks [Q3W]) pembrolizumab in participants with selected solid tumors (i.e. non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma). Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 6 cohorts at the MTD from Phase 1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).
NCT02579616 ↗	Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy	Completed	Eisai Co., Ltd.	Phase 2	2015-10-23	This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase that will last within 21 days; a Treatment phase that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks; and a Follow-up phase that will begin immediately after the Off-Treatment Visit and will continue as long as the participant is alive, unless the participant withdraws consent, or until the End of Study.
NCT02592356 ↗	Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer	Active, not recruiting	National Cancer Institute (NCI)	N/A	2015-11-16	The goal of this clinical research study is to learn about possible weight, muscle, and/or fat loss in patients receiving cabozantinib or lenvatinib.
NCT02592356 ↗	Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer	Active, not recruiting	M.D. Anderson Cancer Center	N/A	2015-11-16	The goal of this clinical research study is to learn about possible weight, muscle, and/or fat loss in patients receiving cabozantinib or lenvatinib.
NCT02640508 ↗	Eribulin and Lenvatinib in Advanced Solid Tumors	Active, not recruiting	Eisai Inc.	Phase 2	2016-05-01	The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.

Clinical Trial Conditions for lenvima

Condition Name

Condition Name for lenvima
Intervention	Trials
Hepatocellular Carcinoma	7
Renal Cell Carcinoma	4
Liver Transplant; Complications	3
Cancer	3

Condition MeSH

Condition MeSH for lenvima
Intervention	Trials
Carcinoma	27
Carcinoma, Hepatocellular	12
Neoplasms	9
Thyroid Neoplasms	8

Clinical Trial Locations for lenvima

Trials by Country

Trials by Country for lenvima
Location	Trials
United States	91
France	19
Japan	16
Spain	15
Germany	14

Trials by US State

Trials by US State for lenvima
Location	Trials
California	10
Massachusetts	9
Texas	9
New York	7
Florida	5

Clinical Trial Progress for lenvima

Clinical Trial Phase

Clinical Trial Phase for lenvima
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2	32

Clinical Trial Status

Clinical Trial Status for lenvima
Clinical Trial Phase	Trials
Not yet recruiting	22
Recruiting	18
Active, not recruiting	5

Clinical Trial Sponsors for lenvima

Sponsor Name

Sponsor Name for lenvima
Sponsor	Trials
Merck Sharp & Dohme Corp.	16
Eisai Inc.	12
Eisai Co., Ltd.	4

Sponsor Type

Sponsor Type for lenvima
Sponsor	Trials
Other	55
Industry	50
NIH	4

Lenvima Market Analysis and Financial Projection

Lenvima (Lenvatinib): Clinical Trials, Market Analysis, and Projections

Introduction

Lenvima, also known as lenvatinib, is a multiple receptor tyrosine kinase (RTK) inhibitor that has been approved for the treatment of various types of cancer, including thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma. This article will delve into recent clinical trial updates, market analysis, and projections for this drug.

Clinical Trials Update

LEAP-012 Trial for Hepatocellular Carcinoma

A significant clinical trial update comes from the LEAP-012 trial, which evaluated the combination of LENVIMA plus KEYTRUDA (pembrolizumab) in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC). The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 34% compared to TACE alone. The median PFS was 14.6 months for the LENVIMA plus KEYTRUDA-based regimen versus 10.0 months for TACE alone[1].

First-Line Treatment for Renal Cell Carcinoma

Another notable trial compared lenvatinib plus pembrolizumab to sunitinib in the first-line treatment of patients with advanced renal cell carcinoma (aRCC). This study showed that the combination of lenvatinib and pembrolizumab achieved superior efficacy, with significant improvements in progression-free survival (PFS) and overall survival (OS) compared to sunitinib. The objective response rate was also improved with this combination[4].

Market Analysis

Market Size and Growth

The global market for lenvatinib is driven by the increasing incidence of cancer worldwide. The market is projected to grow significantly, with the lenvatinib drugs market estimated to expand due to rising healthcare expenditures, growing geriatric populations, and increasing approvals by health authorities. The market size is expected to reach substantial figures by 2025, with a projected CAGR indicating robust growth[2].

Therapeutic Use

Lenvatinib is primarily used in oncology, targeting various cancers such as thyroid, liver, and renal cell carcinoma. Its application spans across different end-use sectors, including pharmaceutical companies, research institutions, and specialty clinics. The drug's versatility in treating multiple types of cancer contributes to its market demand[2].

End-User and Distribution

The drug is used in various settings, including clinics, hospitals, and research institutes. The distribution channels are diverse, catering to different patient demographics and healthcare systems. The market is also influenced by the formulation of the drug, which is available in capsule form[2].

Market Drivers

Key drivers of the lenvatinib market include collaborations between pharmaceutical companies and research institutions, the growing geriatric population, and rising healthcare expenditures. These factors enhance the adoption and accessibility of lenvatinib in treatment plans[2].

Market Restraints

Despite the growth potential, the market faces challenges such as high treatment costs, stringent regulatory frameworks, and side effects associated with the drug. Supply chain disruptions and intellectual property challenges also pose significant hurdles[2].

Market Projections

Global Forecast

The global lenvatinib market is forecasted to grow at a considerable CAGR from 2025 to 2030. This growth is anticipated due to the increasing global cancer incidence, significant investments in oncology research, and the expanding healthcare infrastructure in developing regions[2].

Emerging Markets

There are substantial opportunities in developing markets where healthcare infrastructure is advancing. Tapping into digital health platforms and exploring affordable alternatives in these regions can further drive market growth[2].

Competitive Landscape

The competitive landscape of the lenvatinib market is characterized by strategic partnerships and collaborations between pharmaceutical companies and research institutions. Companies like Eisai and Merck & Co., Inc. are at the forefront, jointly developing and commercializing lenvatinib through the LEAP clinical program[1][2].

Key Growth Factors

Increasing Approval Rate

The increasing approval rate by health authorities for lenvatinib in various cancer types has been a significant growth factor. Recent approvals have expanded the drug's indications, making it a preferred treatment option for several types of cancer[3].

Investments in Oncology Research

Substantial investments in oncology research have driven innovations in targeted therapies like lenvatinib. This research focus has led to better treatment outcomes and increased the drug's market penetration[2].

Rising Healthcare Expenditures

Rising healthcare expenditures globally have driven greater access and adoption of lenvatinib in treatment plans. This trend is expected to continue, supporting market growth[2].

Challenges and Opportunities

Addressing High Treatment Costs

One of the significant challenges is the high cost of lenvatinib treatment. Addressing this through affordable alternatives or pricing strategies could expand the market reach[2].

Regulatory Compliance

Ensuring compliance with stringent regulatory requirements across different regions is crucial. Navigating these regulatory landscapes can be challenging but is essential for market expansion[2].

Digital Health Platforms

Tapping into digital health platforms can enhance patient engagement with lenvatinib therapies. This approach can improve treatment adherence and outcomes, offering a new avenue for market growth[2].

Conclusion

Lenvima, with its broad therapeutic applications and strong clinical trial data, is poised for significant market growth. The combination of lenvatinib with other therapies, such as pembrolizumab, has shown promising results in various cancer types. As the global cancer incidence continues to rise, the demand for targeted therapies like lenvatinib is expected to increase, driven by growing healthcare expenditures and advancements in oncology research.

Key Takeaways

• Clinical Efficacy: Lenvima has demonstrated significant clinical efficacy in combination with other therapies, such as pembrolizumab, in treating various types of cancer.
• Market Growth: The global lenvatinib market is projected to grow substantially due to increasing cancer incidence, investments in oncology research, and rising healthcare expenditures.
• Therapeutic Use: Lenvima is used in treating thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma.
• Market Drivers: Collaborations between pharmaceutical companies, growing geriatric populations, and rising healthcare expenditures are key market drivers.
• Challenges: High treatment costs, stringent regulatory frameworks, and side effects are significant challenges.

FAQs

What is Lenvima used for?

Lenvima (lenvatinib) is used for the treatment of various types of cancer, including thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma[3].

What are the key findings of the LEAP-012 trial?

The LEAP-012 trial showed that the combination of LENVIMA plus KEYTRUDA in combination with TACE reduced the risk of disease progression or death by 34% compared to TACE alone in patients with unresectable, non-metastatic HCC[1].

How is the market for Lenvima expected to grow?

The global lenvatinib market is expected to grow at a considerable CAGR from 2025 to 2030, driven by increasing cancer incidence, investments in oncology research, and rising healthcare expenditures[2].

What are the main challenges facing the Lenvima market?

The main challenges include high treatment costs, stringent regulatory frameworks, and side effects associated with the drug. Additionally, supply chain disruptions and intellectual property challenges pose significant hurdles[2].

What opportunities exist for market expansion?

Opportunities exist in tapping into digital health platforms, exploring affordable alternatives in developing markets, and enhancing market education and awareness among healthcare professionals and consumers[2].

Sources

1. Eisai, "LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Combination with TACE Reduced the Risk of Disease Progression or Death by 34% Compared to TACE Alone in Patients with Unresectable, Non-Metastatic HCC," September 17, 2024.
2. 360iResearch, "Lenvatinib Drugs Market Size & Share 2025-2030," December 2024.
3. Drugs.com, "Lenvima (lenvatinib) FDA Approval History," Updated September 18, 2019.
4. ASCO Publications, "Lenvatinib Plus Pembrolizumab Versus Sunitinib in First-Line Treatment of Patients with Advanced Renal Cell Carcinoma," Journal of Clinical Oncology.