CLINICAL TRIALS PROFILE FOR PADCEV

All Clinical Trials for PADCEV

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03070990 ↗	A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma	Completed	Seagen Inc.	Phase 1	2017-04-24	The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.
NCT03070990 ↗	A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma	Completed	Seattle Genetics, Inc.	Phase 1	2017-04-24	The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.
NCT03070990 ↗	A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma	Completed	Astellas Pharma Inc	Phase 1	2017-04-24	The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.
NCT03219333 ↗	A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer	Active, not recruiting	Seagen Inc.	Phase 2	2017-10-08	This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect. Patients who sign up for this trial must also fall into one of these categories: - Patients have already received treatment with platinum-containing chemotherapy - Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.
NCT03219333 ↗	A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer	Active, not recruiting	Seattle Genetics, Inc.	Phase 2	2017-10-08	This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect. Patients who sign up for this trial must also fall into one of these categories: - Patients have already received treatment with platinum-containing chemotherapy - Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.
NCT03219333 ↗	A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer	Active, not recruiting	Astellas Pharma Global Development, Inc.	Phase 2	2017-10-08	This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect. Patients who sign up for this trial must also fall into one of these categories: - Patients have already received treatment with platinum-containing chemotherapy - Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.
NCT03288545 ↗	A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer	Recruiting	Merck Sharp & Dohme Corp.	Phase 1/Phase 2	2017-10-11	This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

Clinical Trial Conditions for PADCEV

Condition Name

Condition Name for PADCEV
Intervention	Trials
Bladder Cancer	5
Urothelial Cancer	5
Metastatic Urothelial Carcinoma	3
Urothelial Carcinoma Bladder	2

Condition MeSH

Condition MeSH for PADCEV
Intervention	Trials
Urinary Bladder Neoplasms	12
Carcinoma, Transitional Cell	10
Carcinoma	10
Ureteral Neoplasms	7

Clinical Trial Locations for PADCEV

Trials by Country

Trials by Country for PADCEV
Location	Trials
United States	184
Japan	34
France	25
Russian Federation	20
Spain	17

Trials by US State

Trials by US State for PADCEV
Location	Trials
California	10
Texas	10
Ohio	8
New York	8
Pennsylvania	8

Clinical Trial Progress for PADCEV

Clinical Trial Phase

Clinical Trial Phase for PADCEV
Clinical Trial Phase	Trials
PHASE1	2
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PADCEV
Clinical Trial Phase	Trials
RECRUITING	12
Not yet recruiting	5
Active, not recruiting	2

Clinical Trial Sponsors for PADCEV

Sponsor Name

Sponsor Name for PADCEV
Sponsor	Trials
Seagen Inc.	10
Seattle Genetics, Inc.	5
Astellas Pharma Inc	5

Sponsor Type

Sponsor Type for PADCEV
Sponsor	Trials
Industry	41
Other	9
NIH	2

Clinical Trials Update, Market Analysis, and Projection for PADCEV (Enfortumab Vedotin)

Last updated: October 28, 2025

Introduction

PADCEV (enfortumab vedotin) stands as a groundbreaking antibody-drug conjugate (ADC) developed by Seagen Inc., targeting nectin-4, a protein overexpressed in several malignancies, notably urothelial carcinoma. Approved by the U.S. Food and Drug Administration (FDA) in December 2019 for locally advanced or metastatic urothelial carcinoma after prior chemotherapy and immunotherapy, PADCEV is positioned as a pivotal treatment within the oncology landscape. This report provides an in-depth update on ongoing clinical trials, analyzes the market dynamics, and projects its future trajectory based on current evidence and trends.

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Clinical Trials Update

Key Trials and Outcomes

Since its FDA approval, PADCEV has undergone extensive clinical evaluation across phase I, II, and III trials, expanding its indications and refining its efficacy and safety profile.

• EV-301 (Phase III):
  A pivotal randomized trial comparing PADCEV versus standard chemotherapy in previously treated advanced urothelial carcinoma. Published results indicated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS). Median OS: 12.88 months for PADCEV versus 8.97 months for chemotherapy (Hazard Ratio [HR]: 0.70, p<0.001) [1].

• EV-201 (Phase II):
  Demonstrated an objective response rate (ORR) of approximately 44% in patients with advanced urothelial carcinoma previously treated with platinum-based chemotherapy and immunotherapy, with durable responses [2].

• Phase I/II Trials in Other Indications:
  Investigations into PADCEV for metastatic squamous cell carcinoma of the head and neck (SCCHN), breast cancer, and other nectin-4 expressing tumors are ongoing. Preliminary data show promise but require validation in larger cohorts.

Expanding Indications

• Non-Muscle Invasive Bladder Cancer (NMIBC):
  A Phase II trial (EV-103) is exploring intravesical and systemic administration, with early data suggesting safety and potential efficacy, aiming to broaden PADCEV’s indications.

• Combination Therapies:
  Studies are evaluating PADCEV combined with immune checkpoint inhibitors such as pembrolizumab and nivolumab, seeking synergistic effects and enhanced response rates. Early-phase data suggest favorable safety and encouraging efficacy signals.

Emerging Data and Key Considerations

Clinical trials highlight PADCEV’s manageable toxicity profile, predominantly peripheral neuropathy, fatigue, and skin rash. Ongoing research focuses on optimizing dosing regimens, understanding resistance mechanisms, and identifying biomarkers to predict response.

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Market Analysis

Current Market Landscape

Urothelial carcinoma remains a significant global health challenge, with over 570,000 new cases annually worldwide [3]. Treatment options before PADCEV were limited, with platinum-based chemotherapy and immune checkpoint inhibitors being standard. PADCEV’s approval marked a paradigm shift, owing to its targeted mechanism and promising efficacy.

Market Size and Revenue

In 2022, Seagen reported approximately $300 million in global sales of PADCEV, reflecting rapid adoption. The market is projected to reach $1 billion by 2025, driven by:

• Expanded indications
• Increasing clinical evidence support
• Competitive positioning against other ADCs and immunotherapies

Competitive Landscape

PADCEV faces competition from emerging therapies:

• Enfortumab combinations with pembrolizumab and chemotherapy
• Other ADCs targeting nectin-4 or similar antigens
• Immune checkpoint inhibitors like atezolizumab and durvalumab

However, its demonstrated overall survival benefit and manageable safety profile favor its position.

Regulatory Outlook and Market Penetration

Besides the U.S., regulatory agencies in Europe, Japan, and other markets are actively reviewing PADCEV for approval. The drug's unique efficacy profile and expanding evidence base facilitate broader adoption, especially in treatment-refractory settings.

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Future Projections

Growth Drivers

• Indication Expansion:
  Trials investigating PADCEV in earlier lines of therapy and other nectin-4 expressing tumors could unlock new markets.

• Combination Regimens:
  Positive early data on combination therapies are expected to bolster sales, potentially establishing PADCEV as part of multi-drug regimens.

• Biomarker Development:
  Identifying predictive biomarkers may optimize patient selection, increasing response rates and uptake.

• Global Approvals:
  Regulatory clearances in Europe and Asia will significantly expand the commercial footprint.

Challenges

• Toxicity Management:
  Peripheral neuropathy remains a concern; enhanced management strategies are essential to sustain growth.

• Pricing and Reimbursement:
  Ensuring favorable reimbursement policies will influence market penetration, particularly in cost-sensitive regions.

• Resistance and Durability:
  Addressing mechanisms of resistance will be critical in maintaining long-term efficacy.

Forecast Outlook

By 2030, PADCEV is projected to dominate the ADC segment for urothelial carcinoma, exceeding $2 billion in annual revenues globally. Its success hinges on ongoing clinical validation, strategic partnerships, and overcoming safety challenges.

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Conclusion

PADCEV’s clinical trials underscore its robust efficacy in refractory urothelial carcinoma, establishing it as a cornerstone therapy. Market dynamics favor accelerated adoption, especially with upcoming indications and combination strategies. Continued clinical development, paired with strategic regulatory and commercial initiatives, will be imperative to capitalize on its full potential.

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Key Takeaways

• Clinical Validation:
  PADCEV’s Phase III EV-301 trial demonstrated survival benefits, solidifying its role in second-line urothelial carcinoma treatment.

• Market Expansion:
  Anticipated approvals for earlierlines, combination regimens, and other nectin-4 expressing cancers will drive revenue growth.

• Competitive Edge:
  Its targeted mechanism, durable responses, and manageable toxicity position PADCEV favorably against current standard therapies.

• Challenges to Address:
  Toxicity management, resistance, and reimbursement strategies are pivotal for sustained market success.

• Strategic Outlook:
  Ongoing trials and global regulatory efforts suggest PADCEV could become a leading ADC in multiple oncology indications, with revenues surpassing $2 billion annually by the next decade.

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FAQs

1. What is PADCEV, and how does it work?
PADCEV (enfortumab vedotin) is an ADC targeting nectin-4, delivering a cytotoxic agent directly to cancer cells overexpressing nectin-4, thereby inducing cell death selectively.

2. What are the primary indications for PADCEV?
Initially approved for locally advanced or metastatic urothelial carcinoma after chemotherapy and immunotherapy, its potential expansion includes earlier lines of treatment and other nectin-4 positive tumors.

3. How effective is PADCEV based on clinical trials?
In pivotal trials, PADCEV achieved an ORR of approximately 44%, with median overall survival of nearly 13 months, outperforming chemotherapy in second-line settings.

4. What are the main safety concerns associated with PADCEV?
Peripheral neuropathy, rash, fatigue, and alopecia are common adverse events, manageable with dose modifications and supportive care.

5. What is the future outlook for PADCEV in the oncology market?
With ongoing trials in new indications and combinations, PADCEV's market potential is substantial, with projections indicating over $2 billion in annual sales by 2030, contingent on successful regulatory and clinical progress.

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Sources:

[1] Rosenberg, J.E., et al. (2021). The New England Journal of Medicine. Enfortumab vedotin in urothelial carcinoma.
[2] Powles, T., et al. (2021). The Lancet Oncology. Enfortumab vedotin in previously treated urothelial carcinoma.
[3] World Health Organization. (2022). Global Cancer Observatory. Cancer statistics.