CLINICAL TRIALS PROFILE FOR CABOMETYX

All Clinical Trials for CABOMETYX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01708954 ↗	Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2013-02-13	This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.
NCT01709435 ↗	Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 1	2012-11-14	This phase I trial studies the side effects and best dose of cabozantinib S-malate in treating younger patients with solid tumors that have come back or no longer respond to treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01716715 ↗	Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2012-11-06	This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.
NCT01811212 ↗	Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer	Completed	Exelixis	Phase 2	2013-05-08	This phase II trial studies how well cabozantinib-s-malate works in treating patients with thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth of thyroid cancer by blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to the tumor.
NCT01811212 ↗	Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2013-05-08	This phase II trial studies how well cabozantinib-s-malate works in treating patients with thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth of thyroid cancer by blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to the tumor.
NCT01822522 ↗	Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2013-06-21	This phase I trial studies the side effects and best dose of cabozantinib s-malate in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment and human immunodeficiency virus. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01835145 ↗	Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery	Active, not recruiting	Exelisis	Phase 2	2013-07-31	This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma) that has spread to other parts of the body and cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye.

Clinical Trial Conditions for CABOMETYX

Condition Name

Condition Name for CABOMETYX
Intervention	Trials
Renal Cell Carcinoma	7
Metastatic Renal Cell Carcinoma	6
Hepatocellular Carcinoma	4
Recurrent Malignant Solid Neoplasm	4

Condition MeSH

Condition MeSH for CABOMETYX
Intervention	Trials
Carcinoma	47
Carcinoma, Renal Cell	25
Neoplasms	11
Lung Neoplasms	9

Clinical Trial Locations for CABOMETYX

Trials by Country

Trials by Country for CABOMETYX
Location	Trials
United States	747
Spain	31
Australia	27
Italy	26
Germany	23

Trials by US State

Trials by US State for CABOMETYX
Location	Trials
California	31
Missouri	26
Pennsylvania	26
New York	26
Florida	25

Clinical Trial Progress for CABOMETYX

Clinical Trial Phase

Clinical Trial Phase for CABOMETYX
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for CABOMETYX
Clinical Trial Phase	Trials
Recruiting	40
Active, not recruiting	16
Not yet recruiting	14

Clinical Trial Sponsors for CABOMETYX

Sponsor Name

Sponsor Name for CABOMETYX
Sponsor	Trials
National Cancer Institute (NCI)	36
Exelixis	27
Ipsen	7

Sponsor Type

Sponsor Type for CABOMETYX
Sponsor	Trials
Other	69
Industry	59
NIH	36

Clinical Trials Update, Market Analysis, and Projection for Cabometyx (Cabozantinib)

Last updated: October 30, 2025

Introduction

Cabometyx (cabozantinib), developed by Exelixis, is a tyrosine kinase inhibitor (TKI) primarily approved for treating advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and medullary thyroid cancer (MTC). As a cornerstone in targeted oncology therapies, Cabometyx continues to evolve with ongoing clinical trials, shaping its future market trajectory amid competitive dynamics and emerging treatment paradigms.

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Clinical Trials Landscape

Recent and Ongoing Clinical Trials

1. Phase III Trials in Renal Cell Carcinoma

   • COSMIC-313: Investigates cabozantinib combined with nivolumab and ipilimumab for treatment-naïve advanced RCC. The trial aims to assess progression-free survival (PFS) and overall survival (OS). As of late 2022, recruitment remains active, with topline results anticipated in 2024, promising to expand Cabometyx’s indication fold if positive.

2. Hepatocellular Carcinoma

   • CELESTIAL Trial Data Maturation: PubMed and clinicaltrials.gov report ongoing analyses of longer-term outcomes for patients with advanced HCC receiving Cabometyx post-sorafenib. Recent interim results affirm its efficacy, echoing earlier positive data which supported approvals in HCC.

3. Medullary Thyroid Carcinoma

   • EXAMINER Study: Extended investigations into cabozantinib's efficacy in MTC are underway, focusing on durable response rates and disease stabilization. Positive early-phase data have prompted further phase III studies.

4. Emerging Indications

   • Trials exploring cabozantinib in combination with immune checkpoint inhibitors across different tumor types (e.g., prostate, colorectal, and breast cancers) are in early phases, indicating a potential value-add beyond existing indications.

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Market Status and Competitive Position

Market Penetration and Commercial Performance

• Renal Cell Carcinoma

  According to IQVIA data, Cabometyx has solidified its role as an alternative to sunitinib and pazopanib in first-line RCC, with approximately 50% market share among TKIs. Its inclusion in NCCN guidelines lends further credence to its position.

• Hepatocellular Carcinoma

  Post-approval in 2018 for HCC after sorafenib failure, sales have grown steadily, driven by increased off-label use and expanding clinical evidence. In 2022, global sales roughly exceeded $500 million, representing a significant revenue source.

• Medullary Thyroid Cancer

  Though niche, this indication contributes to exclusivity, with stable US and European market shares following FDA approval in 2018.

Market Competition

Key competitors include:

• Lenvatinib (Lenvima)
• Axitinib (Inlyta)
• Sunitinib (Sutent)
• Lenvatinib plus pembrolizumab combination

Emerging therapies, notably immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab), threaten to encroach on Cabometyx's market share, especially as combination regimens demonstrate superior efficacy in various trials.

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Market Projection and Future Trends

Forecast Overview (2023–2030)

Based on current clinical development trends and regulatory pipelines, the global cabozantinib market is poised for robust growth, driven by expanded indications, combination therapies, and persistent unmet needs in oncology.

• 2023–2025: Expect steady growth, reaching approximately $1.2 billion globally by 2025, supported by increasing off-label use and ongoing trials confirming efficacy across tumor types.

• 2026–2030: The market could expand to over $2 billion, owing to regulatory approvals for new indications, combination regimens, and potential first-line uses in RCC and HCC.

Key Growth Drivers

• Expanded Indications: Successful trial outcomes, especially in combination therapies, may lead to regulatory approvals in earlier lines of therapy.

• Combination Strategies: Synergistic use with immune checkpoint inhibitors could redefine treatment standards, boosting sales.

• Geographic Expansion: Emerging markets in Asia-Pacific, Latin America, and Eastern Europe are expected to adopt Cabometyx more broadly.

Risks and Challenges

• Competitive Dynamics: The rising efficacy of immunotherapy-based combination treatments could diminish the role of monotherapy cabozantinib.
• Pricing Pressures and Reimbursement: Healthcare payers may scrutinize cost-effectiveness, especially if lower-cost biologics or generics enter the market.
• Regulatory Hurdles: Delays or refusals in new indications could hamper growth projections.

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Strategic Implications

• Investing in Clinical Development: Continued support for trials like COSMIC-313 and CELESTIAL will augment evidence, supporting label expansion.
• Partnership Opportunities: Collaborations with biotech companies developing immune-oncology combinations could accelerate market penetration.
• Market Access Strategy: Tailored approaches in emerging markets and negotiations with payers are crucial for sustainable growth.

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Key Takeaways

• Clinical Prospects: Ongoing trials promise potential expansion into earlier lines of therapy and new tumor types, which could significantly impact market share.
• Market Dynamics: Cabometyx maintains a strong position in RCC and HCC but faces intensifying competition from immunotherapeutic combinations.
• Growth Outlook: With a projected market size exceeding $2 billion globally by 2030, Cabometyx’s future depends on successful regulatory filings and integration into combination regimens.
• Strategic Focus: Prioritizing clinical trial outcomes, global market access, and strategic alliances will influence its long-term success.
• Competitive Edge: Its proven efficacy, backed by robust clinical data, and ongoing exploration of new indications reinforce its role in targeted oncology therapy.

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FAQs

1. What are the key indications for Cabometyx currently approved by regulators?
Cabometyx is approved for advanced RCC, previously treated HCC, and MTC. These approvals are based on pivotal trials demonstrating significant survival benefits.

2. How might ongoing clinical trials influence Cabometyx’s market position?
Successful outcomes may lead to expanded indications, including first-line RCC and combination therapy approvals, bolstering sales and competitive relevance.

3. What are the major competitors to Cabometyx in its core indications?
Sunitinib, lenvatinib, and axitinib dominate RCC, while sorafenib and lenvatinib compete in HCC. Combining immune checkpoint inhibitors poses a growing challenge.

4. What are the primary risks to Cabometyx’s market growth?
Market share erosion from immunotherapy combinations, regulatory delays, pricing pressures, and emergence of new therapeutics constitute primary risks.

5. What strategic actions should Exelixis pursue to maximize Cabometyx’s potential?
Investing in clinical trials, forming strategic partnerships for combination options, and expanding access in emerging markets are vital for future growth.

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References

1. [Exelixis official pipeline and clinical trial data]
2. IQVIA Market Insights 2022
3. FDA and EMA approval announcements
4. ClinicalTrials.gov database
5. Industry analyses from Bloomberg and EvaluatePharma