CLINICAL TRIALS PROFILE FOR SUTENT

All Clinical Trials for sutent

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00094029 ↗	A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248	Approved for marketing	Pfizer		2004-09-01	The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.
NCT00130897 ↗	Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma	Approved for marketing	Pfizer		2005-07-01	The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.
NCT00137436 ↗	Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer	Completed	Pfizer	Phase 1/Phase 2	2005-10-01	This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).
NCT00246571 ↗	Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer	Completed	Pfizer	Phase 2	2006-01-01	The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.
NCT00265317 ↗	A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone	Completed	Pfizer	Phase 2	2006-06-01	This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen
NCT00291577 ↗	Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer	Completed	Pfizer	Phase 1	2006-07-01	This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.

Clinical Trial Conditions for sutent

Condition Name

Condition Name for sutent
Intervention	Trials
Renal Cell Carcinoma	22
Metastatic Renal Cell Carcinoma	15
Stage IV Renal Cell Cancer	11
Carcinoma, Renal Cell	10

Condition MeSH

Condition MeSH for sutent
Intervention	Trials
Carcinoma	79
Carcinoma, Renal Cell	78
Kidney Neoplasms	19
Neoplasms	14

Clinical Trial Locations for sutent

Trials by Country

Trials by Country for sutent
Location	Trials
United States	976
Canada	97
Japan	63
Australia	51
Italy	49

Trials by US State

Trials by US State for sutent
Location	Trials
Texas	48
California	45
Ohio	45
New York	40
Illinois	39

Clinical Trial Progress for sutent

Clinical Trial Phase

Clinical Trial Phase for sutent
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	16
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for sutent
Clinical Trial Phase	Trials
Completed	123
Terminated	42
Recruiting	17

Clinical Trial Sponsors for sutent

Sponsor Name

Sponsor Name for sutent
Sponsor	Trials
Pfizer	88
National Cancer Institute (NCI)	50
M.D. Anderson Cancer Center	11

Sponsor Type

Sponsor Type for sutent
Sponsor	Trials
Other	180
Industry	174
NIH	52

Sutent Market Analysis and Financial Projection

SUTENT (Sunitinib Malate): Clinical Trials, Market Analysis, and Projections

Introduction to SUTENT

SUTENT, also known as sunitinib malate, is a small-molecule tyrosine kinase inhibitor developed and marketed by Pfizer Inc. It is administered orally and has been approved for the treatment of several types of cancer, including renal cell carcinoma (RCC), imatinib-resistant gastrointestinal stromal tumor (GIST), and pancreatic neuroendocrine tumors (pNET)[3].

Clinical Trials Update

Gastrointestinal Stromal Tumors (GIST)

In a pivotal clinical trial (Study 1), SUTENT was evaluated in patients with GIST who had disease progression during prior imatinib treatment or were intolerant of imatinib. This 2-arm, international, randomized, double-blind, placebo-controlled trial demonstrated a statistically significant advantage for SUTENT over placebo in time-to-tumor progression (TTP) and progression-free survival (PFS). Patients receiving SUTENT had a median overall survival (OS) of 72.7 weeks compared to 64.9 weeks for those receiving placebo[1].

Renal Cell Carcinoma (RCC)

SUTENT was also investigated in the adjuvant treatment setting for RCC in the S-TRAC trial. This multi-center, international, randomized, double-blind, placebo-controlled trial involved patients with high-risk RCC following nephrectomy. The trial showed a statistically significant improvement in disease-free survival (DFS) for patients treated with SUTENT compared to placebo[1].

Pancreatic Neuroendocrine Tumors (pNET)

In a study involving patients with unresectable pNET, SUTENT was compared to placebo. Patients receiving SUTENT showed improved progression-free survival (PFS) and overall survival (OS) compared to those on placebo[1].

Combination Therapy with Bezuclastinib

Recent updates include the ongoing Phase 3 PEAK trial by Cogent Biosciences, evaluating the combination of bezuclastinib and SUTENT in patients with advanced GIST. The preliminary data indicate a median progression-free survival (mPFS) of 19.4 months and an objective response rate (ORR) of 33% in a subset of patients. This combination therapy has shown encouraging long-term safety and tolerability[4].

Market Analysis

Market Size and Growth

The global SUTENT market is projected to grow significantly over the next decade. By 2033, the market is expected to reach approximately USD 378.0 million, up from USD 120.6 million in 2023, with a compound annual growth rate (CAGR) of 12.1% during the forecast period from 2024 to 2033[2].

Application Analysis

SUTENT is primarily used in the treatment of three main types of cancer:

• Pancreatic Neuroendocrine Tumors (pNET): This segment accounted for 41.3% of the market share in 2023.
• Kidney Cancer (RCC): A significant portion of the market, driven by the drug's efficacy in treating RCC.
• Gastrointestinal Stromal Tumors (GIST): Another key application area, especially for patients resistant to imatinib[2].

Regional Analysis

The market is dominated by North America, which accounts for approximately 40% of the market revenue, followed by Europe and the Asia-Pacific region. Emerging markets, particularly in regions like China and India, present significant growth opportunities due to increasing healthcare infrastructure and awareness[2].

Drivers of Growth

The growth of the SUTENT market is driven by several factors:

• Increasing Incidence of Targeted Cancers: Rising cases of pancreatic neuroendocrine tumors, kidney cancer, and GIST are driving the demand for SUTENT.
• Advancements in Research and Development: Ongoing research and the development of novel applications, formulations, and combination therapies are expanding the market.
• Precision Medicine Trend: SUTENT fits into the trend of personalized and targeted therapies, enhancing its significance in modern oncology[2].

Restraints and Opportunities

While the market is growing, there are some restraints:

• High Cost of Research and Development: The cost associated with developing and maintaining SUTENT can be a barrier.
• High Cost of the Drug: The expense of SUTENT itself can limit accessibility in some markets[3].

However, opportunities abound:

• Expansion into Emerging Markets: There is significant potential in expanding SUTENT into regions with growing healthcare infrastructure and increasing cancer burden.
• Pipeline Development and New Indications: Ongoing clinical trials and the identification of new indications can further expand the market potential for SUTENT[2].

Market Projections

Forecast Period

The forecast period from 2024 to 2033 is expected to see robust growth for the SUTENT market. Here are some key projections:

• Market Size: Expected to reach USD 378.0 million by 2033 from USD 120.6 million in 2023.
• CAGR: Projected to grow at a CAGR of 12.1% during the forecast period.
• Regional Growth: North America will continue to dominate, but emerging markets will also see significant growth[2].

Competitive Landscape

The market is competitive, with key players including Pfizer, Brawn Laboratories Ltd, Topcare Pharmaceutical Co. Ltd, Hetero Drugs Ltd, and others. Strategic collaborations and partnerships are becoming more common, driving innovation and the development of novel formulations and combination therapies[2].

Key Takeaways

• Growing Market: The SUTENT market is expected to grow significantly, driven by increasing cancer incidence and advancements in research.
• Clinical Efficacy: SUTENT has shown strong clinical efficacy in treating GIST, RCC, and pNET.
• Regional Opportunities: Emerging markets offer substantial growth potential.
• Combination Therapies: The combination of SUTENT with other drugs, like bezuclastinib, is showing promising results.

FAQs

What is SUTENT used for?

SUTENT (sunitinib malate) is used for the treatment of renal cell carcinoma (RCC), imatinib-resistant gastrointestinal stromal tumor (GIST), and pancreatic neuroendocrine tumors (pNET).

What are the key clinical trials for SUTENT?

Key clinical trials include Study 1 for GIST, S-TRAC for RCC, and the ongoing PEAK trial evaluating the combination of bezuclastinib and SUTENT for advanced GIST.

What is the projected market size for SUTENT by 2033?

The global SUTENT market is expected to reach approximately USD 378.0 million by 2033.

What are the main drivers of the SUTENT market growth?

The growth is driven by the increasing incidence of targeted cancers, advancements in research and development, and the trend towards precision medicine.

What are the potential restraints for the SUTENT market?

High costs associated with research and development and the high cost of the drug itself are significant restraints.

Sources

1. Pfizer Medical Information: SUTENT® (sunitinib malate) Clinical Studies - US.
2. Market.us: Sunitinib Malate Market Size, Share, Outlook | CAGR of 12.1%.
3. IndustryArc: Sunitinib Malate Market Size, Share | Industry Trend & Forecast 2030.
4. Biospace: Cogent Biosciences Announces Positive Updated Lead-In Data from Ongoing Phase 3 PEAK Trial.