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CLINICAL TRIALS PROFILE FOR INLYTA

All Clinical Trials for Inlyta

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00700258 ↗	Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]	Recruiting	Pfizer		2008-01-04	The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use
NCT01321437 ↗	Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma	Completed	Pfizer	Phase 2	2011-12-01	The purpose of this research study is to determine the efficacy of Axitinib in treating individuals with Stage III melanoma.
NCT01321437 ↗	Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma	Completed	University of California, Irvine	Phase 2	2011-12-01	The purpose of this research study is to determine the efficacy of Axitinib in treating individuals with Stage III melanoma.
NCT01409200 ↗	Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2012-03-26	This randomized phase IIA trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with previously untreated prostate cancer that is known or suspected to have spread to lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as antiandrogen therapy may lessen the amount of androgen made by the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if antiandrogen therapy is more effective with or without axitinib before surgery in treating patients with prostate cancer.
NCT01409200 ↗	Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis	Active, not recruiting	Pfizer	Phase 2	2012-03-26	This randomized phase IIA trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with previously untreated prostate cancer that is known or suspected to have spread to lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as antiandrogen therapy may lessen the amount of androgen made by the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if antiandrogen therapy is more effective with or without axitinib before surgery in treating patients with prostate cancer.
NCT01409200 ↗	Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis	Active, not recruiting	M.D. Anderson Cancer Center	Phase 2	2012-03-26	This randomized phase IIA trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with previously untreated prostate cancer that is known or suspected to have spread to lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as antiandrogen therapy may lessen the amount of androgen made by the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if antiandrogen therapy is more effective with or without axitinib before surgery in treating patients with prostate cancer.
NCT01529138 ↗	Study of Axitinib and Temsirolimus in Solid Tumors	Completed	Pfizer	Phase 1	2011-10-01	This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine how the patient's disease responds to treatment. The combination of the drugs temsirolimus and axitinib has not been studied before so it is unknown whether this treatment will have any benefit in the patient's cancer. Temsirolimus is commercially available and approved for treatment of some types of kidney cancer. Axitinib has been tested in several diseases but it is not yet commercially available for the treatment of any cancer in the United States. The combination of temsirolimus and axitinib is not approved for treatment of any cancer outside of a clinical trial.

Clinical Trial Conditions for Inlyta

Condition Name

Condition Name for Inlyta
Intervention	Trials
Clear Cell Renal Cell Carcinoma	7
Renal Cell Carcinoma	7
Metastatic Renal Cell Carcinoma	4
Carcinoma, Renal Cell	3

Condition MeSH

Condition MeSH for Inlyta
Intervention	Trials
Carcinoma, Renal Cell	24
Carcinoma	21
Neoplasms	5
Melanoma	5

Clinical Trial Locations for Inlyta

Trials by Country

Trials by Country for Inlyta
Location	Trials
United States	217
Russian Federation	10
Korea, Republic of	10
Japan	10
Canada	8

Trials by US State

Trials by US State for Inlyta
Location	Trials
Texas	14
California	13
New York	10
Florida	9
Ohio	9

Clinical Trial Progress for Inlyta

Clinical Trial Phase

Clinical Trial Phase for Inlyta
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	34
Phase 1/Phase 2	5

Clinical Trial Status

Clinical Trial Status for Inlyta
Clinical Trial Phase	Trials
Recruiting	16
Completed	11
Not yet recruiting	7

Clinical Trial Sponsors for Inlyta

Sponsor Name

Sponsor Name for Inlyta
Sponsor	Trials
Pfizer	19
National Cancer Institute (NCI)	9
Bristol-Myers Squibb	4

Sponsor Type

Sponsor Type for Inlyta
Sponsor	Trials
Industry	56
Other	43
NIH	9

Clinical Trials, Market Analysis, and Projections for INLYTA (Axitinib)

Introduction to INLYTA (Axitinib)

INLYTA (axitinib) is an oral tyrosine kinase inhibitor designed to target vascular endothelial growth factor (VEGF) receptors 1, 2, and 3, which are involved in tumor growth, vascular angiogenesis, and the progression of cancer. Here, we will delve into the recent clinical trials, market analysis, and future projections for INLYTA.

Clinical Trials Update

Phase 3 ATLAS Trial

The Phase 3 ATLAS trial was conducted to evaluate INLYTA as an adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy. However, the trial was stopped at a planned interim analysis due to futility, as it failed to demonstrate a clear improvement in disease-free survival (DFS) compared to the placebo group. Despite this, the safety profile of INLYTA remained consistent with its known profile in advanced RCC[1].

JAVELIN Renal 101 Trial

In the JAVELIN Renal 101 trial, INLYTA was evaluated in combination with avelumab for untreated advanced RCC. This randomized, multicenter, open-label study showed a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to sunitinib. The combination also demonstrated a higher objective response rate (ORR)[4].

KEYNOTE-426 Trial

The KEYNOTE-426 trial investigated INLYTA in combination with pembrolizumab for patients with advanced RCC who had not received prior systemic therapy. This trial also showed statistically significant improvements in OS, PFS, and ORR compared to sunitinib. The combination was well-tolerated, and patients could continue treatment beyond RECIST-defined disease progression if clinically stable and deriving benefit[4].

Market Analysis

Current Market Position

INLYTA is currently approved for the treatment of advanced RCC after failure of one prior systemic therapy in the U.S. and the EU. Despite the setback in the ATLAS trial, INLYTA remains a significant player in the RCC treatment landscape, particularly when used in combination with immune checkpoint inhibitors like avelumab and pembrolizumab[1][4].

Market Size and Projections

The renal cell carcinoma market is projected to be substantial, with estimates suggesting it could reach $3.6 billion by 2023. INLYTA, along with other drugs like Opdivo, is expected to be a key contributor to this market growth[3].

Competitive Landscape

The RCC market is highly competitive, with several drugs vying for market share. However, the combination therapies involving INLYTA have shown promising results, positioning it favorably against competitors. For instance, the combination of INLYTA with pembrolizumab has demonstrated superior efficacy compared to sunitinib, a traditional standard of care[4].

Financial Performance and Projections

Revenue Impact

Pfizer's financial reports indicate that while INLYTA's revenue may not be as significant as some of Pfizer's other products, it still contributes to the company's overall revenue growth. The decline in revenue from other products like Comirnaty has been offset by growth in other segments, including those driven by INLYTA and its combination therapies[2].

Future Revenue Projections

Given the positive outcomes from combination therapy trials, INLYTA is expected to see increased adoption and revenue growth. Pfizer has raised its full-year revenue guidance, partly due to the strong performance of its oncology portfolio, which includes INLYTA[2].

Safety and Efficacy Profile

Safety Profile

The safety profile of INLYTA has been consistent across various trials. No new safety signals were observed in the ATLAS trial, and the combination studies with avelumab and pembrolizumab have shown manageable side effects, aligning with the known safety profile of INLYTA[1][4].

Efficacy Profile

INLYTA has demonstrated significant efficacy in advanced RCC, particularly when combined with immune checkpoint inhibitors. These combinations have shown improvements in OS, PFS, and ORR, making INLYTA a valuable treatment option for patients with advanced RCC[4].

Regulatory and Development Outlook

Ongoing Studies

Pfizer continues to evaluate INLYTA in combination with immune checkpoint inhibitors for various advanced stage cancers, including RCC. These ongoing studies are expected to provide further insights into the efficacy and safety of these combinations[1].

Regulatory Approvals

While the ATLAS trial did not meet its primary endpoint, INLYTA's approvals in the U.S. and EU for advanced RCC remain intact. Future regulatory submissions for combination therapies are anticipated, which could further expand INLYTA's indications and market reach[1][4].

Key Takeaways

• Clinical Trials: INLYTA's use as an adjuvant therapy in the ATLAS trial was unsuccessful, but combination therapies with avelumab and pembrolizumab have shown significant promise.
• Market Analysis: The RCC market is substantial, and INLYTA, especially in combination therapies, is expected to contribute significantly.
• Financial Performance: INLYTA's revenue, though not the highest, contributes to Pfizer's overall revenue growth, with future projections looking positive.
• Safety and Efficacy: INLYTA's safety profile is well-established, and its efficacy in combination therapies is robust.
• Regulatory Outlook: Ongoing studies and potential future approvals could expand INLYTA's market presence.

FAQs

What is INLYTA used for?

INLYTA (axitinib) is used for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.

What were the results of the ATLAS trial?

The ATLAS trial evaluating INLYTA as an adjuvant therapy for patients at high risk of recurrent RCC after nephrectomy was stopped due to futility, as it failed to demonstrate a clear improvement in disease-free survival (DFS) compared to the placebo group.

How does INLYTA perform in combination therapies?

INLYTA has shown statistically significant improvements in OS, PFS, and ORR when combined with immune checkpoint inhibitors like avelumab and pembrolizumab in advanced RCC.

What is the current market size for RCC treatments?

The renal cell carcinoma market is projected to be around $3.6 billion by 2023.

What are the future revenue projections for INLYTA?

Given the positive outcomes from combination therapy trials, INLYTA is expected to see increased adoption and revenue growth, contributing to Pfizer's overall revenue guidance.

Sources

1. Pfizer Provides Update on Phase 3 Trial of Axitinib as Adjuvant Treatment for Patients at High Risk of Renal Cell Carcinoma Recurrence After Surgery. Pfizer Inc.
2. Pfizer Reports Strong Second-Quarter 2024 Results And Raises Full-Year 2024 Revenue Guidance. Pfizer Inc.
3. Report: Renal cell carcinoma to be a $3.6bn market by 2023. Clinical Trials Arena.
4. INLYTA® (axitinib) Clinical Studies. Pfizer Medical Information - US.