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.

Clinical Trial Conditions for LENVIMA

Condition Name

Condition Name for LENVIMA
Intervention	Trials
Hepatocellular Carcinoma	7
Renal Cell Carcinoma	4
Advanced Cancer	3
Liver Transplant; Complications	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
Australia	14

Trials by US State

Trials by US State for LENVIMA
Location	Trials
California	10
Texas	9
Massachusetts	9
New York	7
Pennsylvania	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
Completed	5

Clinical Trial Sponsors for LENVIMA

Sponsor Name

Sponsor Name for LENVIMA
Sponsor	Trials
Merck Sharp & Dohme Corp.	16
Eisai Inc.	12
National Cancer Institute (NCI)	4

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Lenvima (Lenvatinib)

Last updated: October 28, 2025

Introduction

Lenvima (lenvatinib), developed by Eisai Co., Ltd., is an oral multi-kinase inhibitor approved for the treatment of various cancers, notably differentiated thyroid carcinoma (DTC), hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), and endometrial carcinoma. With a broad therapeutic profile, Lenvima has established a strategic position within the oncology market, driven by ongoing clinical developments and expanding indications. This report synthesizes recent clinical trial updates, provides a comprehensive market analysis, and forecast future growth trajectories for Lenvima.

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Clinical Trials Update

Recent Phase III Trials and Indications

Lenvatinib’s clinical development pipeline remains robust, with multiple ongoing studies targeting novel indications and combination therapies. Several pivotal trials have yielded positive outcomes, reaffirming its therapeutic efficacy.

• Thyroid Cancer (DTC and Anaplastic)

  The DECISION trial (2015) established Lenvima’s approval for radioiodine-refractory differentiated thyroid cancer (RR-DTC). Subsequently, the RELIANCE trial is assessing Lenvatinib in anaplastic thyroid carcinoma (ATC). Preliminary data indicate promising activity, though final outcomes are pending.

• Hepatocellular Carcinoma (HCC)

  The LEAP-002 trial, a Phase III study evaluating Lenvima plus pembrolizumab versus sorafenib in unresectable HCC, reported interim results showing a trend toward improved progression-free survival (PFS). The combination holds potential as a first-line therapy, complementing existing standards.

• Renal Cell Carcinoma (RCC)

  The CLEAR trial (ClinicalTrials.gov NCT02673775) demonstrated superior progression-free survival and objective response rates (ORR) for Lenvatinib combined with pembrolizumab in advanced RCC, leading to its FDA approval for this combination.

• Endometrial Carcinoma

  The LEAP-ES-14 trial evaluated the combination of Lenvatinib and pembrolizumab in advanced endometrial carcinoma, showing significant improvements in ORR and progression metrics. The FDA granted accelerated approval for this indication.

Ongoing Trials and Expanded Indications

Several Phase I and II studies are exploring Lenvatinib in new cancer types such as:

• Non-small cell lung cancer (NSCLC)
• Gastric and esophageal cancers
• Thymic carcinoma

Additionally, combination trials with immunotherapies aim to enhance therapeutic outcomes and expand Lenvima’s indication spectrum.

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Market Analysis

Global Market Landscape

Lenvima’s market position is bolstered by its proven efficacy across multiple oncology indications and its strategic role in combination therapies. The global cancer therapeutics market is projected to surpass USD 230 billion by 2026, with targeted therapies comprising a significant growth segment.

• Market Penetration

  In 2022, Lenvima generated approximately USD 1.5 billion globally, primarily driven by sales in the US, Europe, and Japan. Its primary competitors include Sorafenib, Regorafenib, and newer immunotherapy agents.

• Geographical Distribution

  Japan remains the largest market due to early approval and high prescribing rates. North America accounts for around 45% of sales, with Europe comprising approximately 20%. The Asia-Pacific region is anticipated to see rapid growth owing to expanding indications and increased healthcare access.

Competitive Position and Differentiators

Unlike traditional TKIs, Lenvatinib's broad kinase inhibition profile allows efficacy across various tumor types. Its oral administration route also provides convenience, favoring patient adherence. The combination of Lenvatinib with immune checkpoint inhibitors (e.g., pembrolizumab) positions it at the forefront of combination regimen market growth.

Market Drivers and Challenges

Drivers:

• Expanding indications via clinical trial successes
• Growing prevalence of cancers such as HCC, RCC, and endometrial carcinoma
• Favorable safety profile and oral administration

Challenges:

• Competition from other targeted agents and immunotherapies
• Managing adverse events, including hypertension and fatigue
• Patent expirations and generic entry risks

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Market Projection and Future Outlook

Forecast Overview

The Lenvima market is projected to grow at a compound annual growth rate (CAGR) of approximately 12% from 2023 to 2030, driven by:

• Approvals for new indications (e.g., gastric, lung cancers)
• Successful completion and positive outcomes of ongoing pivotal trials
• Increased adoption of combination therapies

By 2030, Lenvima’s global sales are forecasted to reach USD 4-5 billion, capturing a significant share of the targeted oncology therapeutics market. Asia-Pacific, especially China and India, is expected to contribute substantially to the growth, leveraging population size and rising cancer incidence.

Strategic Factors Influencing Growth

• Pipeline Advancements: Positive trial results for combination regimens with checkpoint inhibitors will likely lead to broader approvals.
• Regulatory Approvals: Expanded labels in multiple cancer types will further solidify market presence.
• Manufacturing and Supply Chain: Enhanced capacity and strategic partnerships will ensure product availability and pricing competitiveness.
• Pricing and Reimbursement: Favorable reimbursement environments, especially in emerging markets, will facilitate market penetration.

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Key Takeaways

• Lenvatinib remains a dominant multi-kinase inhibitor with validated efficacy in thyroid, kidney, liver, and endometrial cancers.
• Clinical trials are ongoing in various tumor types, with combination therapies garnering particular interest and showing promising results.
• The global market for Lenvima is poised for substantial growth, supported by expanding indications, strategic collaborations, and clinical advancements.
• Competitive positioning hinges on sustained clinical success, regulatory approvals for new indications, and effective commercialization strategies.

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FAQs

1. What are the primary approved indications for Lenvima?
   Lenvima is approved for differentiated thyroid carcinoma refractory to radioiodine therapy, unresectable HCC, advanced RCC (in combination with pembrolizumab), and endometrial carcinoma (in combination with pembrolizumab).

2. What ongoing clinical trials could influence Lenvima’s future market?
   Notable trials include LEAP-002 (HCC), trials in gastric and lung cancers, and further combination therapy studies with immunotherapies that may lead to broader approvals.

3. How does Lenvima compare to its competitors?
   Lenvima’s broad kinase inhibition, oral delivery, and proven efficacy in combination therapies distinguish it from competitors like sorafenib and regorafenib. Its efficacy in combination regimens offers a unique market advantage.

4. What are the key challenges facing Lenvima’s market expansion?
   Challenges include competition from newer agents, managing adverse events, patent expiration risks, and navigating regulatory landscapes across different regions.

5. What is the long-term sales outlook for Lenvima?
   With expanding indications and successful clinical milestones, Lenvima’s sales are expected to approach USD 4–5 billion globally by 2030, assuming continued clinical success and market penetration.

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References

[1] Eisai Co., Ltd. Lenvatinib (Lenvima) clinical trial updates.
[2] Global Oncology Market Report 2022. MarketResearch.com.
[3] ClinicalTrials.gov. Database of ongoing trials involving Lenvatinib.
[4] FDA Press Releases and Approvals.
[5] IQVIATM Report 2023. Oncology Therapies Market Analysis.