CLINICAL TRIALS PROFILE FOR COMETRIQ

All Clinical Trials for COMETRIQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01683994 ↗	Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2012-09-07	Background: - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate tumors respond to it. Docetaxel and prednisone are standard treatments for advanced prostate cancer. Researchers want to see if adding cabozantinib to these two drugs can be a safe and effective treatment for this type of cancer. Objectives: - To test the safety and effectiveness of cabozantinib with standard treatments for advanced prostate cancer. Eligibility: - Individuals at least 18 years of age who have advanced prostate cancer that has not responded to standard treatments. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will also be performed. - Participants will receive the cancer drugs over 21-day cycles of treatment. They will take docetaxel and cabozantinib on day 1 of each cycle. Each docetaxel infusion will take about 1 hour. They will also take prednisone by mouth twice each day. - Treatment will be monitored with frequent blood tests and imaging studies. - Participants will continue to take the study drugs for as long as their cancer does not worsen and side effects are not too severe.
NCT01688999 ↗	Cabozantinib for Advanced Urothelial Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2012-09-11	Background: - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian tumors respond to it. Researchers want see if cabozantinib can be a safe and effective treatment for urothelial cancer. Objectives: - To test the safety and effectiveness of cabozantinib for advanced urothelial cancer. Eligibility: - Individuals at least 18 years of age who have advanced urothelial cancer that has not responded to standard treatments. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor tissue samples will also be collected. Imaging studies will also be performed. - Participants will take cabozantinib by mouth once per day on each day of a 28-day cycle. - Treatment will be monitored with frequent blood tests and imaging studies. - Participants will continue to take the study drug for as long as their cancer does not worsen and side effects are not too severe.
NCT01703065 ↗	Cabozantinib in Men With Castration-Resistant Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2013-06-18	This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01703065 ↗	Cabozantinib in Men With Castration-Resistant Prostate Cancer	Terminated	Prostate Cancer Foundation	Phase 2	2013-06-18	This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01703065 ↗	Cabozantinib in Men With Castration-Resistant Prostate Cancer	Terminated	University of Washington	Phase 2	2013-06-18	This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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.

Clinical Trial Conditions for COMETRIQ

Condition Name

Condition Name for COMETRIQ
Intervention	Trials
Stage IV Renal Cell Cancer AJCC v8	4
Recurrent Malignant Solid Neoplasm	4
Unresectable Osteosarcoma	3
Recurrent Hepatocellular Carcinoma	3

Condition MeSH

Condition MeSH for COMETRIQ
Intervention	Trials
Carcinoma	31
Carcinoma, Renal Cell	10
Neoplasms	9
Adenocarcinoma	7

Clinical Trial Locations for COMETRIQ

Trials by Country

Trials by Country for COMETRIQ
Location	Trials
United States	618
Canada	14
Japan	5
Germany	5
Belgium	5

Trials by US State

Trials by US State for COMETRIQ
Location	Trials
California	27
Pennsylvania	23
Illinois	21
Ohio	21
Massachusetts	20

Clinical Trial Progress for COMETRIQ

Clinical Trial Phase

Clinical Trial Phase for COMETRIQ
Clinical Trial Phase	Trials
Phase 3	3
Phase 2/Phase 3	2
Phase 2	38

Clinical Trial Status

Clinical Trial Status for COMETRIQ
Clinical Trial Phase	Trials
Recruiting	19
Active, not recruiting	15
Completed	9

Clinical Trial Sponsors for COMETRIQ

Sponsor Name

Sponsor Name for COMETRIQ
Sponsor	Trials
National Cancer Institute (NCI)	40
Exelixis	14
Emory University	4

Sponsor Type

Sponsor Type for COMETRIQ
Sponsor	Trials
NIH	40
Other	27
Industry	17

Clinical Trials Update, Market Analysis, and Projection for COMETRIQ

Last updated: February 1, 2026

Executive Summary

COMETRIQ (cabozantinib) is an orally administered tyrosine kinase inhibitor with approved indications primarily for medullary thyroid carcinoma (MTC) and renal cell carcinoma (RCC). Over recent years, its clinical development, regulatory landscape, and market dynamics have evolved significantly. This report summarizes recent clinical trial updates, analyzes the current market landscape, and projects future market potential through 2028.

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Clinical Trials Update: Recent Developments and Ongoing Studies

Major Clinical Trials and Regulatory Milestones

Trial/Approval	Phase	Indication	Status	Key Findings/Notes	Regulatory Status
EXAM Study (for MTC)	Phase III	Medullary thyroid carcinoma	Completed	Significant progression-free survival (PFS) extension (median PFS: 11.2 vs. 4.0 months for placebo)	Approved in US, EU, Japan (2012-2014)
METEOR Study (for RCC)	Phase III	Metastatic RCC	Completed	Improved PFS and overall survival (OS); ORR ~36%	Approved for RCC treatment (2016 in US, 2018 in EU)
CABOMETYX Trials	Various	Advanced solid tumors & other indications	Ongoing	Expanded into hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), and additional RCC subsets	Regulatory submissions ongoing
CABOMETYX + Nivolumab	Phase Ib/II	RCC	Actively recruiting	Evaluating combination efficacy	Anticipated completion 2024
MTC Treatment in Pediatric Patients	Phase I	Pediatric MTC	Recruiting	Assessing safety in younger populations	Expected completion 2025

Notable Updates (2022–2023)

• FDA and EMA Approvals: COMETRIQ remains approved for MTC with an additional approval in 2022 for advanced RCC post-VEGF targeted therapy.
• New Indications: Early Phase II trials explore efficacy in hepatocellular carcinoma and non-small cell lung cancer. Results expected from 2024-2025.
• Real-World Evidence (RWE): Data indicate sustained efficacy in metastatic settings, with manageable safety profiles, supporting ongoing label expansion efforts.

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Market Analysis: Current Landscape and Competitive Context

Market Size and Growth

Parameter	2022	2023 Estimate	2028 Projection	Sources & Notes
Global Radiology & Oncology Drug Market	~$30 billion	~$35 billion	~$50 billion	CAGR ~8% (2022–2028) [1]
Medullary Thyroid Carcinoma Market (global)	~$150 million	~$180 million	~$250 million	Based on prevalence and treatment rates [2]
Renal Cell Carcinoma Market (global)	~$5 billion	~$6 billion	~$9 billion	Driven by increased RCC incidence and targeted therapies [3]

Competitive Landscape

Drug	Indications	Mechanism	Approval Year	Market Share (2023)	Key Competitors
COMETRIQ (cabozantinib)	MTC, RCC, others	Tyrosine kinase inhibitor (VEGFR, MET, AXL)	2012 (MTC), 2016 (RCC)	~50% (MTC), ~45% (RCC)	Lenvatinib, Vandetanib (MTC); Nivolumab + Ipilimumab, Axitinib (RCC)
Vandetanib	MTC	VEGFR, RET inhibitor	2011	20%
Lenvatinib	RCC, thyroid	VEGFR, FGFR inhibitor	2015	25%
Nivolumab (Opdivo)	RCC, others	PD-1 inhibitor	2015	15%

Pricing and Reimbursement Trends

• Pricing: Approximately $12,000–$14,000/month in the US for COMETRIQ; cost considerations influence market adoption.
• Reimbursement: Covered under Medicare and major insurers; ongoing updates from payers toward value-based models.

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Market Projection: 2024–2028

Drivers of Growth

• Expanded indications: Clinical success in HCC, NSCLC, and other solid tumors.
• Line of therapy positioning: Moves into first-line treatments for RCC and into combination regimens.
• Regulatory approvals: Anticipated approvals for pediatric MTC, additional solid tumors.
• Combination strategies: Synergies with immunotherapies (PD-1/PD-L1 inhibitors) promising higher response rates.

Potential Market Penetration Scenarios

Scenario	Assumptions	2028 Market Size (USD)	Details
Conservative	No expansion beyond current indications; slow uptake	~$2.5 billion	Existing methyl partial but limited growth
Moderate	Approved for 2–3 new indications, rapid adoption	~$4.5 billion	Driven by combination therapies, increased line of care
Aggressive	Significant expansion into multiple solid tumor indications, accelerated approvals	~$6.5 billion	Major market penetration, high adoption rates

Estimated Revenue (2024–2028)

Year	Estimated Revenue (USD Millions)	Growth Rate	Source/Assumption
2024	~$800	15% growth	Based on current market trends, early approvals
2025	~$1,000	25% growth	Launch of additional indications, combo trials
2026	~$1,300	30% growth	Broader labeling, accelerated adoption
2027	~$1,700	30% growth	Market maturity
2028	~$2,200	25% growth	Maturation of indications

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Comparative Analysis: COMETRIQ vs. Key Competitors

Parameter	COMETRIQ	Vandetanib	Lenvatinib	Axitinib	Nivolumab + Ipilimumab
Mechanism	Multi-kinase inhibitor	RET, VEGFR	VEGFR, FGFR	VEGFR	PD-1/CTLA-4 checkpoint inhibitors
Primary Indication	MTC, RCC	MTC	RCC, thyroid	RCC	RCC, melanoma
Approval Year	2012 (MTC), 2016 (RCC)	2011	2015	2012	2015
Avg. Monthly Cost (USD)	~$13,500	~$12,000	~$13,000	~$13,000	~$15,000 (combination)
Market Share (2023)	~50% (MTC), ~45% (RCC)	20%	25%	10%	15%

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Regulatory and Policy Landscape

• FDA & EMA Approvals: Ongoing efforts to expand use in RCC, HCC, NSCLC.
• Payer Coverage: Likely to evolve with emerging evidence, emphasizing cost-effectiveness.
• Orphan Drug Designation: Confirmed for MTC, incentivizing expedited development.

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Deep Dive: Future Outlook and Challenges

Opportunities

• Extension into novel indications: HCC, NSCLC, combination with immunotherapy.
• Biomarker-driven treatment: Identifying molecular markers for patient stratification.
• Market expansion into emerging economies: India, China are becoming significant markets.

Challenges

• Competition: Multiple TKIs and immunotherapies vying for the same patient populations.
• Pricing pressures: Payers demanding value-based pricing.
• Safety profiles: Managing adverse events to maintain patient adherence.

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Key Takeaways

• COMETRIQ maintains a pivotal position in medullary thyroid carcinoma and renal cell carcinoma markets, with ongoing clinical trials targeting expanding indications.
• The drug's market size is projected to grow at a compound annual growth rate (CAGR) of approximately 15–20% through 2028, mainly driven by label expansions and combination therapy approvals.
• Competitive pressure from other TKIs and immunotherapies will shape market share dynamics; strategic differentiation remains critical.
• Regulatory momentum and positive RWE support future growth but depend on successful navigation of safety and efficacy profiles in broader populations.
• Pricing and reimbursement strategies will significantly influence commercial success amidst increasing payer scrutiny.

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FAQs

1. What are the key indications for COMETRIQ as of 2023?
Primarily approved for medullary thyroid carcinoma and renal cell carcinoma. Clinical trials are exploring its efficacy in hepatocellular carcinoma, non-small cell lung cancer, and other solid tumors.

2. Are there upcoming regulatory decisions that could impact COMETRIQ’s market?
Yes. Expected approvals for HCC and combination therapy indications in 2024–2025 could significantly expand its market footprint.

3. How does COMETRIQ compare economically with its competitors?
Its monthly therapy cost (~$13,500) is comparable to other TKIs. Reimbursement frameworks largely support its use, but cost-effectiveness evaluations are ongoing and could influence future coverage.

4. What are the main clinical challenges faced by COMETRIQ?
Managing adverse events such as hypertension, diarrhea, fatigue, and potential drug resistance remains crucial for optimizing patient outcomes and adherence.

5. How might emerging therapies impact COMETRIQ’s market share?
The rise of checkpoint inhibitors and novel targeted agents may challenge COMETRIQ’s dominance, especially if combination regimens demonstrate superior efficacy or improved safety profiles.

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References

[1] Market Research Future. (2022). Oncology Drugs Market Analysis.
[2] GlobalData. (2023). Thyroid Cancer Market Report.
[3] IQVIA. (2023). Oncology Market Trends.

(Note: For full citation details, please refer to the respective reports and studies titled in brackets.)