CLINICAL TRIALS PROFILE FOR TEMSIROLIMUS

505(b)(2) Clinical Trials for Temsirolimus

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 Indication	NCT02093598 ↗	POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus	Completed	MedSIR	Phase 2	2012-05-01	Type of Application: Clinical trial of new indication. Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses). Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09. Primary Objective: - To identify in tumor samples future biomarkers associated with a short term exposure to temsirolimus. - This is an exploratory clinical study. No efficacy objectives are included in this clinical trial. Secondary Objectives: - To estimate the tolerability for all temsirolimus-treated patients throughout the study and up to 28 days after the last dose of temsirolimus. - To correlate observed changes with the different type of endometrial carcinoma (type I and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D, p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR), - To estimate the potential predictive value of some biomarkers (immunostaining for PTEN, pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite instability status. - To estimate the prognostic value of Ki67 expression after short-term presurgical therapy exposure - To collect data about the differences in expression profile, assessed by RNA microarrays
New Combination	NCT03571438 ↗	Evaluation of a Promising New Combination of Protein Kinase Inhibitors on Organotypic Cultures of Human Renal Tumors	Recruiting	University Hospital, Grenoble	N/A	2017-10-16	The investigators objective is to test the combination directly on organotypic cultures of tumors from patients after their excision in the Department of Urology and Renal Transplantation of the University Hospital of Grenoble and to compare their efficacy with that of currently selected treatments in the clinic. The population targeted by the combination for use in clinical practice is patients with metastatic clear cell renal cell carcinoma. Current treatments for these patients are Sunitinib, Pazopanib and Temsirolimus.

All Clinical Trials for Temsirolimus

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003712 ↗	CCI-779 in Treating Patients With Advanced Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 1	2001-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
NCT00003712 ↗	CCI-779 in Treating Patients With Advanced Solid Tumors	Completed	University of Texas	Phase 1	2001-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
NCT00003712 ↗	CCI-779 in Treating Patients With Advanced Solid Tumors	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2001-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
NCT00003712 ↗	CCI-779 in Treating Patients With Advanced Solid Tumors	Completed	The University of Texas Health Science Center at San Antonio	Phase 1	2001-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
NCT00012142 ↗	CCI-779 in Treating Patients With Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2000-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to determine the effectiveness of CCI-779 in treating patients who have progressive prostate cancer.
NCT00012142 ↗	CCI-779 in Treating Patients With Prostate Cancer	Completed	Jonsson Comprehensive Cancer Center	Phase 2	2000-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to determine the effectiveness of CCI-779 in treating patients who have progressive prostate cancer.

Clinical Trial Conditions for Temsirolimus

Condition Name

Condition Name for Temsirolimus
Intervention	Trials
Renal Cell Carcinoma	13
Unspecified Adult Solid Tumor, Protocol Specific	10
Advanced Cancer	10
Kidney Cancer	8

Condition MeSH

Condition MeSH for Temsirolimus
Intervention	Trials
Carcinoma	51
Carcinoma, Renal Cell	42
Neoplasms	38
Lymphoma	25

Clinical Trial Locations for Temsirolimus

Trials by Country

Trials by Country for Temsirolimus
Location	Trials
United States	979
Canada	104
Germany	37
Australia	29
France	29

Trials by US State

Trials by US State for Temsirolimus
Location	Trials
Texas	62
California	48
New York	43
Pennsylvania	42
Illinois	40

Clinical Trial Progress for Temsirolimus

Clinical Trial Phase

Clinical Trial Phase for Temsirolimus
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	9
Phase 2	92

Clinical Trial Status

Clinical Trial Status for Temsirolimus
Clinical Trial Phase	Trials
Completed	139
Terminated	31
Active, not recruiting	15

Clinical Trial Sponsors for Temsirolimus

Sponsor Name

Sponsor Name for Temsirolimus
Sponsor	Trials
National Cancer Institute (NCI)	86
Pfizer	33
Wyeth is now a wholly owned subsidiary of Pfizer	24

Sponsor Type

Sponsor Type for Temsirolimus
Sponsor	Trials
Other	185
Industry	110
NIH	87

Temsirolimus: Clinical Trials, Market Analysis, and Projections

Introduction to Temsirolimus

Temsirolimus, marketed under the brand name TORISEL, is a targeted therapy used primarily in the treatment of advanced renal cell carcinoma (RCC), a type of kidney cancer. It works by inhibiting the mammalian target of rapamycin (mTOR), a critical regulator of cell growth and proliferation.

Clinical Trials Overview

Phase 3 Clinical Study

A pivotal phase 3, multi-center, three-arm, randomized, open-label study was conducted to evaluate the efficacy and safety of temsirolimus in previously untreated patients with advanced RCC. This study compared overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in patients receiving interferon-alpha (IFN-α) alone, temsirolimus alone (25 mg weekly), or a combination of temsirolimus (15 mg) and IFN-α[1][4].

• Patient Demographics: The study included 626 patients, with a mean age of 59 years, 69% male, and 91% White. Sixty-seven percent of the patients had a history of prior nephrectomy.
• Treatment Outcomes: The study showed a statistically significant improvement in OS in the temsirolimus 25 mg arm compared to IFN-α, with median OS of 10.9 months versus 7.3 months, respectively. The combination arm did not show a significant increase in OS compared to IFN-α alone. PFS was also significantly longer in the temsirolimus arm (5.5 months) compared to the IFN-α arm (3.1 months)[1][4].

Market Analysis

Global Market Size and Growth

The global temsirolimus market is experiencing significant growth driven by its increasing use in cancer treatment, particularly for renal cell carcinoma.

• Current Market Size: As of 2023, the global temsirolimus market was valued at approximately USD 145 million[2] or USD 5.03 billion, depending on the source and market segmentation[3].
• Forecasted Growth: The market is expected to grow at a compound annual growth rate (CAGR) of 6.2% from 2024 to 2030, reaching USD 226.7 million by 2030[2], or at a CAGR of 5.1% from 2024 to 2031, reaching USD 7.49 billion by 2031[3].

Regional Market Segmentation

The temsirolimus market is segmented across various regions, including:

• North America: Expected to grow significantly, driven by advanced healthcare infrastructure and high adoption rates of targeted therapies.
• Europe: Key markets include Germany, France, the UK, and Italy, with significant growth anticipated due to increasing cancer incidence and advanced healthcare systems.
• Asia-Pacific: Countries like China, Japan, and India are driving growth due to a large patient population and increasing access to advanced cancer treatments.
• South America and Middle East & Africa: These regions are also expected to contribute to the market growth, albeit at a slower pace compared to other regions[2][3].

Key Manufacturers

The major global manufacturers of temsirolimus include:

• Pfizer: The original developer and marketer of TORISEL.
• Gland Pharma: Known for its generic and biosimilar products.
• Accord Healthcare: Another significant player in the generic and biosimilar market[2].

Market Drivers and Trends

Increasing Cancer Incidence

The global incidence of cancer, particularly renal cell carcinoma, is a major driver of the temsirolimus market. As the population ages and lifestyle factors contribute to higher cancer rates, the demand for effective cancer treatments is increasing[3].

Advances in Targeted Therapies

Developments in targeted therapeutics and oncology research are propelling the market forward. Temsirolimus, as an mTOR inhibitor, is part of this trend towards more precise and effective cancer treatments[3].

Ongoing Clinical Trials

Ongoing clinical trials investigating novel indications and combination therapies with existing oncology medications are further fueling the market growth. These trials aim to expand the therapeutic applications of temsirolimus and improve treatment outcomes[3].

Personalized Medicine

The emphasis on personalized medicine and targeted cancer therapy is also driving the adoption of temsirolimus. As healthcare moves towards more tailored treatment approaches, drugs like temsirolimus are becoming increasingly important[3].

Challenges and Opportunities

Regulatory Approvals

While temsirolimus has been approved for several cancer indications, ongoing regulatory approvals for new indications and combination therapies will be crucial for market expansion.

Competitive Landscape

The market is competitive, with multiple manufacturers offering generic and biosimilar versions of temsirolimus. This competition can drive down prices but also increases the need for innovative marketing and distribution strategies.

Emerging Markets

Emerging markets in Asia-Pacific, South America, and the Middle East & Africa present significant opportunities for growth. These regions have large patient populations and are increasingly adopting advanced cancer treatments.

Key Takeaways

• Clinical Efficacy: Temsirolimus has demonstrated significant improvements in OS and PFS in clinical trials compared to traditional treatments like IFN-α.
• Market Growth: The global temsirolimus market is expected to grow substantially, driven by increasing cancer incidence and advances in targeted therapies.
• Regional Segmentation: The market is segmented across various regions, with North America, Europe, and Asia-Pacific being key drivers.
• Manufacturers: Pfizer, Gland Pharma, and Accord Healthcare are major players in the market.
• Market Drivers: Increasing cancer incidence, advances in targeted therapies, and ongoing clinical trials are key drivers of the market.

FAQs

What is temsirolimus used for?

Temsirolimus is primarily used in the treatment of advanced renal cell carcinoma (RCC), a type of kidney cancer.

What are the key findings from the phase 3 clinical trial of temsirolimus?

The phase 3 trial showed a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) in patients receiving temsirolimus compared to those receiving interferon-alpha (IFN-α)[1][4].

What is the projected market size of temsirolimus by 2030?

The global temsirolimus market is expected to reach USD 226.7 million by 2030, growing at a CAGR of 6.2% from 2024 to 2030[2].

Who are the major manufacturers of temsirolimus?

The major global manufacturers of temsirolimus include Pfizer, Gland Pharma, and Accord Healthcare[2].

What are the key drivers of the temsirolimus market?

The key drivers include increasing cancer incidence, advances in targeted therapies, ongoing clinical trials, and the emphasis on personalized medicine[3].

Sources

1. Pfizer Medical Information: TORISEL® (temsirolimus) Clinical Studies Patient information - US[1].
2. QYResearch: Global Temsirolimus Market Research Report 2024[2].
3. Market Research Intellect: Temsirolimus Market Size and Projections[3].
4. Pfizer Medical Information: TORISEL® (temsirolimus) Clinical Studies[4].