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.

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
Stage III Renal Cell Cancer AJCC v8	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
Korea, Republic of	10
Japan	10
Russian Federation	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
PHASE1	1
Phase 3	2
Phase 2	34

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
Merck Sharp & Dohme Corp.	4

Sponsor Type

Sponsor Type for INLYTA
Sponsor	Trials
Industry	56
Other	44
NIH	9

Inlyta (Axitinib): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Inlyta (axitinib), developed by Pfizer, is an oral tyrosine kinase inhibitor primarily indicated for the treatment of advanced renal cell carcinoma (RCC). Since its FDA approval in 2012, Inlyta has established a significant presence in oncology therapeutics. This comprehensive analysis synthesizes recent clinical trial developments, assesses current market dynamics, and projects future trends for Inlyta within the oncology landscape.

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Clinical Trials Update

Ongoing and Recently Completed Trials

Inlyta continues to be evaluated in various clinical settings beyond its initial indication:

• Combination Therapies in RCC:
  Recent Phase III trials, such as the AXIOM phase III study (NCT03937219), explore the efficacy of axitinib combined with immunotherapies like pembrolizumab or avelumab. Early data indicate enhanced progression-free survival (PFS) and overall response rates (ORR) compared to monotherapy, aligning with growing evidence supporting combination strategies.

• Adjuvant and Neoadjuvant Settings:
  Trials assessing axitinib's utility post-nephrectomy (NCT03141334) aim to evaluate its role in preventing recurrence. Although results remain preliminary, these studies could expand Inlyta's indications if positive.

• Other Tumor Types:
  Investigations into axitinib's efficacy against gastrointestinal stromal tumors (GIST), hepatocellular carcinoma (HCC), and thyroid cancers are ongoing. For instance, a phase II trial (NCT03138121) in HCC patients is assessing safety and efficacy metrics.

Key Clinical Findings

• Efficacy in RCC:
  Landmark trials, including the AXIS trial (2013), demonstrated superior PFS and ORR of axitinib versus sorafenib in metastatic RCC patients. The median PFS ranged from 10.1 to 15.7 months depending on the study population, reinforcing its position as a second-line standard of care.

• Safety Profile:
  The safety profile remains consistent: manageable hypertension, diarrhea, fatigue, and hand-foot syndrome. Dose modifications effectively mitigate adverse events, supporting its tolerability profile.

• Immunotherapy Combinations:
  Trials combining axitinib with immune checkpoint inhibitors have shown promising preliminary results, stimulating interest in these regimens as frontline therapies.

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Market Analysis

Current Market Dynamics

• Market Size and Revenue:
  The global RCC therapeutics market was valued at approximately USD 5.2 billion in 2022 and is projected to grow at a CAGR of 8.2% through 2030 [1]. Inlyta is a prominent player within this segment, with estimated 2022 revenues around USD 600–700 million globally.

• Competitive Landscape:
  Key competitors include targeted agents like sunitinib, pazopanib, and cabozantinib, alongside immunotherapies such as nivolumab. The emergence of combination regimens—particularly axitinib+pembrolizumab—has begun to shift the landscape, offering potentially superior efficacy and changing prescribing patterns.

• Pricing and Reimbursement:
  As an oral targeted therapy, Inlyta commands premium pricing in markets like the U.S. and Europe. Reimbursement remains favorable when aligned with treatment guidelines, though price pressures from biosimilars and generics for related drugs influence market dynamics.

• Market Penetration Factors:
  Factors impacting Inlyta’s adoption include clinician familiarity, emerging evidence on combination regimens, and regulatory approvals in new indications or combinations. Pfizer's ongoing clinical trials and licensing deals facilitate broader access drives.

Market Challenges

• Competition from Immunotherapies:
  The rising prominence of immune checkpoint inhibitors as monotherapy or in combination diminishes reliance solely on VEGFR inhibitors such as Inlyta.

• Side Effect Management:
  Managing adverse effects remains crucial. Dose adjustments and patient monitoring influence treatment adherence.

• Market Saturation in RCC:
  The proliferation of competing agents diminishes growth potential in established indications unless new uses or combination regimens demonstrate clear superiority.

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Future Market Projections

Forecast Overview

• Growth Drivers:

  • Expansion of combination therapy protocols involving axitinib and immune checkpoint inhibitors.
  • Investigation into earlier application, including adjuvant settings, potentially broadening the patient population.
  • Ongoing clinical trials evaluating new tumor types could open additional markets.

• Market Penetration Strategies:
  Pfizer’s focus on demonstrating superior efficacy with combination regimens and expanding into emerging markets will underpin growth. Strategic licensing and cooperative clinical development initiatives could further augment Inlyta’s footprint.

• Projected Revenue:
  By 2030, the market share of Inlyta is expected to increase modestly, reaching USD 1.2–1.5 billion globally. The CAGR through 2030 is projected at approximately 7% to 9%, driven by successful trial outcomes and expanded indications.

Emerging Trends

• Personalized Oncology:
  Precision medicine approaches, including biomarker-driven patient selection, will optimize Inlyta's use, potentially improving outcomes and cost-effectiveness.

• Regulatory Approvals:
  Direct approvals for combination regimens and new tumor types could accelerate adoption rates.

• Digital and Market Access Initiatives:
  Enhanced digital strategies for patient adherence and education, alongside policy shifts favoring oral agents, can elevate Pfizer’s market positioning.

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Key Takeaways

• Continuous clinical trials reinforce Inlyta's efficacy in RCC, particularly within combination treatment frameworks involving immune checkpoint inhibitors.
• Market dynamics favor Inlyta's position but are increasingly challenged by immune therapies and emerging targeted agents.
• The future of Inlyta hinges on demonstrating superior efficacy in combination regimens, expanding indications, and leveraging personalized treatment approaches.
• Regulatory advancements and strategic collaborations will be crucial for maintaining and expanding its market share.
• Clinical innovation and strong safety profiles underpin the potential for sustained growth in a competitive oncology space.

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FAQs

1. What are the latest clinical developments for Inlyta?
Recent trials focus on combining axitinib with immunotherapies (pembrolizumab, avelumab), promising improved response rates in RCC treatments, and exploring its potential in other cancers such as HCC.

2. How does Inlyta compare to other RCC therapies?
Inlyta has demonstrated superior PFS over sorafenib in second-line settings. Its safety profile is comparable, but combination therapies with immunotherapy agents may offer enhanced efficacy, positioning it favorably in treatment algorithms.

3. What is the potential of Inlyta in expanding beyond RCC?
While currently approved for RCC, ongoing trials in GIST, thyroid cancers, and HCC aim to broaden its oncological indications, pending positive clinical outcomes.

4. How is market competition affecting Inlyta?
The rise of immunotherapies and combination regimens has shifted treatment paradigms, potentially hindering pure VEGFR inhibitor sales but also creating opportunities for integrated or combination approaches.

5. What are the key factors influencing Inlyta’s revenue growth?
Efficacy of combination therapies, regulatory approvals, clinical trial outcomes, patient access programs, and strategic marketing efforts will determine future revenue trajectories.

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References

[1] Grand View Research. “Renal Cell Carcinoma Market Size, Share & Trends Analysis Report.” 2022.