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Last Updated: January 6, 2025

CLINICAL TRIALS PROFILE FOR AFINITOR


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505(b)(2) Clinical Trials for afinitor

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT02520063 ↗ Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Active, not recruiting Novartis Pharmaceuticals Phase 1/Phase 2 2016-02-01 This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
New Combination NCT02520063 ↗ Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Active, not recruiting Tracon Pharmaceuticals Inc. Phase 1/Phase 2 2016-02-01 This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
New Combination NCT02520063 ↗ Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Active, not recruiting University of Alabama at Birmingham Phase 1/Phase 2 2016-02-01 This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for afinitor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00081874 ↗ RAD001 in Relapsed or Refractory AML, ALL, CML in Blastic-Phase, Agnogenic Myeloid Metaplasia, CLL, T-Cell Leukemia, or Mantle Cell Lymphoma Completed Novartis Phase 1/Phase 2 2004-04-01 The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how effective the dose that is found is as a treatment.
NCT00081874 ↗ RAD001 in Relapsed or Refractory AML, ALL, CML in Blastic-Phase, Agnogenic Myeloid Metaplasia, CLL, T-Cell Leukemia, or Mantle Cell Lymphoma Completed M.D. Anderson Cancer Center Phase 1/Phase 2 2004-04-01 The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how effective the dose that is found is as a treatment.
NCT00303732 ↗ Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors Completed Novartis Phase 1 2004-12-01 RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and everolimus and to see how well they work in treating patients with advanced solid tumors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for afinitor

Condition Name

Condition Name for afinitor
Intervention Trials
Breast Cancer 15
Metastatic Breast Cancer 9
Neuroendocrine Tumors 8
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Condition MeSH

Condition MeSH for afinitor
Intervention Trials
Carcinoma 42
Breast Neoplasms 33
Carcinoma, Renal Cell 31
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Clinical Trial Locations for afinitor

Trials by Country

Trials by Country for afinitor
Location Trials
United States 634
Italy 74
France 46
Spain 37
Canada 35
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Trials by US State

Trials by US State for afinitor
Location Trials
Texas 59
California 34
Pennsylvania 29
New York 25
Florida 24
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Clinical Trial Progress for afinitor

Clinical Trial Phase

Clinical Trial Phase for afinitor
Clinical Trial Phase Trials
Phase 4 9
Phase 3 14
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for afinitor
Clinical Trial Phase Trials
Completed 90
Terminated 27
Active, not recruiting 25
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Clinical Trial Sponsors for afinitor

Sponsor Name

Sponsor Name for afinitor
Sponsor Trials
Novartis 48
National Cancer Institute (NCI) 37
Novartis Pharmaceuticals 37
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Sponsor Type

Sponsor Type for afinitor
Sponsor Trials
Other 202
Industry 121
NIH 44
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Afinitor Market Analysis and Financial Projection

Clinical Trials and Market Analysis of Afinitor (Everolimus)

Introduction to Afinitor

Afinitor, also known by its generic name everolimus, is a targeted therapy used in the treatment of various types of cancer and other conditions. It is developed and marketed by Novartis and has been approved for several indications, including advanced renal cell carcinoma, pancreatic neuroendocrine tumors, and hormone receptor-positive advanced breast cancer.

Clinical Trials Update

RADIANT-4 Trial

One of the significant clinical trials for Afinitor is the RADIANT-4 study. This Phase III trial investigated the efficacy and safety of everolimus in patients with advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin. The trial, which involved 302 patients, demonstrated that everolimus plus best supportive care significantly extended progression-free survival (PFS) compared to placebo plus best supportive care. This study met its primary endpoint and is part of one of the largest clinical trial programs in NET[1].

Benign Kidney Tumors Trial

Another notable trial involved the use of everolimus in patients with benign kidney tumors, specifically angiomyolipomas. Conducted by Fox Chase Cancer Center, this study found that everolimus decreased tumor volume in patients with these benign tumors, even in those without the genetic disorder tuberous sclerosis. The trial showed a significant reduction in tumor size, with over 55% of patients experiencing a greater than 25% reduction in tumor volume at four months and 71% at six months[4].

Market Analysis

Current Market Size and Forecast

The global market for Afinitor has seen varying forecasts. As of 2023, the market was estimated to be worth around $512 million. However, projections for the future are mixed. One report suggests that the market will decline to $255.2 million by 2030, with a CAGR of -7.6% during the forecast period 2024-2030[2].

In contrast, another report projects a more optimistic outlook, with the market expected to reach $1.046 billion by 2030, growing at a CAGR of 4.8% during the same period. This growth is driven by increasing cancer incidence, ongoing clinical trials exploring new indications, and advancements in drug delivery mechanisms[3].

Market Drivers

Several factors drive the growth of the Afinitor market:

  • Increasing Cancer Incidence: The global rise in cancer cases, particularly in advanced stages, increases the demand for effective oncology treatments like Afinitor[3].
  • Ongoing Clinical Trials: Continuous research and clinical trials exploring new therapeutic indications for Afinitor expand its potential applications and contribute to market growth[3].
  • Advancements in Drug Delivery: Improvements in drug delivery mechanisms and formulations enhance the efficacy and safety profile of Afinitor, making it more appealing to healthcare providers and patients[3].
  • Regulatory Approvals: Expanded indications and regulatory approvals in various regions boost the market prospects for Afinitor[3].

Market Opportunities

The Afinitor market presents several opportunities for growth:

  • Precision Medicine: Advancements in precision medicine and biomarker-driven approaches offer opportunities for personalized treatment regimens, optimizing therapeutic outcomes for patients receiving Afinitor[3].
  • Strategic Collaborations: Partnerships between pharmaceutical companies and research institutions facilitate the development of innovative formulations and combination therapies, further expanding the market potential[3].
  • Global Demand: The increasing incidence of cancer worldwide, coupled with an aging population and lifestyle factors, provides a vast patient pool for Afinitor therapy[3].

Competitive Landscape

The Afinitor market is dominated by Novartis, the sole manufacturer and marketer of the drug. The competitive landscape involves strategic collaborations, new product launches, and regional expansions. The market report highlights the strengths, weaknesses, opportunities, and threats (SWOT analysis) of key players, including Novartis, and provides insights into their regional footprint and industry presence[5].

Geographical Segmentation

The Afinitor market is segmented geographically into North America, Europe, Asia Pacific, and the rest of the world. Each region has its own market dynamics, influenced by factors such as country GDP, market trends, and regulatory environments. The report provides detailed analysis and forecasts for each region, helping stakeholders understand the lucrative opportunities and challenges in different geographical areas[5].

Conclusion

Afinitor, with its proven efficacy in various clinical trials and its expanding market, remains a significant player in the oncology treatment landscape. Despite mixed market forecasts, the drug's potential is bolstered by increasing cancer incidence, ongoing research, and advancements in drug delivery. As the market continues to evolve, strategic collaborations and precision medicine approaches are expected to drive further growth and innovation.

Key Takeaways

  • Clinical Trials: Afinitor has shown significant efficacy in trials such as RADIANT-4 and in treating benign kidney tumors.
  • Market Size: The market is forecasted to either decline or grow, depending on the source, but is driven by increasing cancer incidence and advancements in treatment.
  • Market Drivers: Increasing cancer cases, ongoing clinical trials, and advancements in drug delivery are key drivers.
  • Market Opportunities: Precision medicine, strategic collaborations, and global demand offer significant growth opportunities.
  • Geographical Segmentation: The market is segmented into North America, Europe, Asia Pacific, and the rest of the world, each with its own market dynamics.

FAQs

Q: What is Afinitor used for? A: Afinitor (everolimus) is used for the treatment of various types of cancer, including advanced renal cell carcinoma, pancreatic neuroendocrine tumors, and hormone receptor-positive advanced breast cancer.

Q: What were the findings of the RADIANT-4 trial? A: The RADIANT-4 trial found that everolimus plus best supportive care significantly extended progression-free survival (PFS) compared to placebo plus best supportive care in patients with advanced nonfunctional neuroendocrine tumors of GI or lung origin[1].

Q: How does Afinitor affect benign kidney tumors? A: A clinical trial showed that everolimus decreased tumor volume in patients with benign kidney tumors (angiomyolipomas), even in those without the genetic disorder tuberous sclerosis[4].

Q: What are the market forecasts for Afinitor? A: Market forecasts vary, with one report suggesting a decline to $255.2 million by 2030 and another projecting growth to $1.046 billion by 2030[2][3].

Q: What drives the growth of the Afinitor market? A: The growth is driven by increasing cancer incidence, ongoing clinical trials, advancements in drug delivery mechanisms, and regulatory approvals for expanded indications[3].

Sources

  1. Novartis Media Release: "Novartis drug Afinitor extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine tumors."
  2. Valuates Reports: "Afinitor - Market, Report Size, Worth, Revenue, Growth, Industry Research."
  3. PharmiWeb: "Afinitor Drug Market is Projected to Reach USD 1046 Mn by 2030 with CAGR of 4.8%."
  4. Fox Chase Cancer Center: "Clinical Trial for Everolimus Shows Decreased Tumor Volume for Patients with Benign Kidney Tumors."
  5. Verified Market Reports: "Afinitor Market Size, Share, Scope, Trends And Forecast 2030."

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