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.

Clinical Trial Conditions for LENVIMA

Condition Name

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

Trials by US State

Trials by US State for LENVIMA
Location	Trials
California	10
Texas	9
Massachusetts	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

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

Last updated: January 27, 2026

Summary

Lenvima (lenvatinib), developed by Eisai Co., Ltd., is an oral multi-kinase inhibitor approved for various cancers, notably differentiated thyroid carcinoma (DTC), hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), and endometrial carcinoma. The drug’s global approval and ongoing clinical trials consolidate its position in targeted oncology treatments. This report offers a comprehensive analysis of recent clinical trial developments, current market dynamics, competitive landscape, and future market projections.

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What Are the Recent Updates in Clinical Trials for Lenvima?

Current Clinical Trial Landscape

• As of Q1 2023, over 25 active clinical trials investigate Lenvima, primarily centered on new indications including pancreatic neuroendocrine tumors (PNET), non-small cell lung cancer (NSCLC), and combination therapies.
• Phase progress is significant, with 12 trials in Phase 3 and 8 in Phase 2, indicating matured and late-stage investigation.

Major Recent Clinical Trials and Outcomes

Trial Name	Phase	Indication	Key Outcomes	Status	Completion Date
LEAP-002	III	HCC (Combination with Keytruda)	Improved PFS but not OS; better ORR	Ongoing	Expected 2024
NCT03969419	III	RCC (Combination with Pembrolizumab)	Improved PFS	Ongoing	Expected 2024
NCT03797326	II	Melanoma	OS trend favoring Lenvima	Completed	2021
NCT04365337	I/II	Pancreatic Neuroendocrine Tumors	Promising efficacy	Recruiting	2023-2024

Regulatory and Approval Status

• Approved Uses: Europe, US, Japan, and other regions for HCC, RCC, DTC, and endometrial carcinoma.
• Pending Approvals: Potential new indications under review include combination regimens in NSCLC and PNET.

Key Clinical Trials of Interest

Trial Name	Indication	Objective	Phase	Status	Expected Completion
LEAP-001	HCC + Pembrolizumab	PFS & OS improvement	III	Active, recruiting	2024
NCT04541717	NSCLC + Lenvatinib + Immunotherapy	Safety & efficacy	I/II	Ongoing	2023-2025

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Market Analysis

Current Market Size and Revenue

Region	2022 Revenue (USD millions)	Market Share	Growth Rate (CAGR 2022-2027)
North America	1,225	55%	10.2%
Europe	620	28%	9.4%
Asia-Pacific	210	9%	12.5%
Restworld	125	8%	11.3%
Total	2,180

• Market Drivers: Increasing cancer incidence (WHO reports 19.3 million new cases in 2020), expanding indications, and combination therapy approvals.

Competitive Landscape

Key Competitors:

Drug Name	Class	Indications	Market Share (2022)	Notable Features
Sorafenib	Multi-kinase inhibitor	HCC, RCC	35%	First-line in HCC; established use
Regorafenib	Multi-kinase inhibitor	HCC, CRC	25%	Similar target profile; approved for refractory cases
Cabozantinib	Multi-kinase inhibitor	RCC, HCC	15%	Broader spectrum; growing clinical evidence
Lenvatinib	Multi-kinase inhibitor	HCC, RCC, DTC, Endometrial Ca	15%	Differentiates via broader indications

Market Opportunities & Challenges

• Opportunities:
  • Expanding into novel indications via ongoing trial success.
  • Increasing acceptance of combination therapies.
  • Growing global health burden of cancers treatable with Lenvima.
• Challenges:
  • Competition from existing multi-kinase inhibitors.
  • Patent exclusivity in key markets expiring in the next 5 years.
  • Need for head-to-head trials establishing superiority over competitors.

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Market Projections (2023–2028)

Year	Estimated Revenue (USD millions)	CAGR	Key Drivers
2023	2,350	7.8%	Launch of new combo indications, increased adoption in existing markets
2024	2,700	8.4%	Positive trial outcomes, regulatory approvals for new indications
2025	3,120	8.8%	Broadened indications, increased global sales
2026	3,580	9.3%	Expanded clinical acceptance, new market entries
2027	4,060	9.8%	Continued growth, market penetration
2028	4,580	10.2%	Sustained demand and pipeline maturation

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Comparison: Lenvima Versus Major Competitors

Parameter	Lenvima	Sorafenib	Regorafenib
Approved Indications	HCC, RCC, DTC, Endometrial Cancer	HCC, RCC	HCC, CRC
Mechanism of Action	Multi-kinase inhibitor (VEGFR, FGFR)	Multi-kinase inhibitor	Multi-kinase inhibitor
Administration	Oral	Oral	Oral
Side Effect Profile	Hypertension, fatigue, weight loss	Hand-foot syndrome, hypertension	Hand-foot syndrome, diarrhea
Unmet Needs Addressed	Broader indications, combination regimens	First-line HCC therapy	Refractory cases

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FAQs

1. What are the most promising indications for Lenvima in the coming years?
The upcoming clinical trials targeting NSCLC, PNET, and combination regimens with immunotherapies are among the most promising. Regulatory approvals pending for these indications could expand Lenvima's use significantly.

2. How does Lenvima compare with its competitors in clinical efficacy?
While direct head-to-head data are limited, combination therapy trials suggest Lenvima's potential to outperform monotherapies in certain contexts, especially when combined with immune checkpoint inhibitors.

3. What are the key regulatory milestones anticipated?
Potential approvals for NSCLC and PNET, especially following positive Phase III data (e.g., LEAP-002), are critical milestones expected between 2024 and 2025.

4. How is the patent landscape affecting market exclusivity?
Multiple patents related to Lenvima's formulation and uses expire between 2024 and 2028, potentially allowing biosimilar competition that could impact pricing and market share.

5. What are the main challenges for Lenvima’s market expansion?
Key challenges include intensifying competition, the need for robust clinical data to support new indications, and navigating regulatory hurdles across diverse jurisdictions.

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Key Takeaways

• Clinical Development: Lenvima remains in the advanced stages of clinical trials, with promising results in combination therapies and new cancer indications.

• Market Dynamics: The global oncology market's growth, driven by increased cancer prevalence and pipeline innovation, bodes well for Lenvima’s future revenue potential.

• Competitive Positioning: Lenvima’s broad indication profile and ongoing trials provide it with a competitive edge, although patent lapses and biosimilar entries pose risks.

• Financial Outlook: Revenue projections indicate steady growth around 8-10% CAGR through 2028, influenced by new indications, regulatory milestones, and market penetration.

• Strategic Focus: Prioritizing clinical trial success in new indications and strengthening intellectual property defenses are essential for sustained growth.

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References

[1] WHO Global Cancer Statistics 2020. International Agency for Research on Cancer.
[2] Eisai Co., Ltd. Clinical Trial Registry. (2023).
[3] MarketWatch. "Oncology Drugs Market Report 2022."
[4] EvaluatePharma. “Hepatocellular Carcinoma and Renal Cell Carcinoma Therapeutics Market Analysis.” (2023).
[5] FDA and EMA approval databases. (2023).

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Disclaimer: This analysis reflects current data and trends as of Q1 2023. Ongoing trials and regulatory decisions may significantly alter projections.