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.

Clinical Trial Conditions for PADCEV

Condition Name

Condition Name for PADCEV
Intervention	Trials
Bladder Cancer	5
Urothelial Cancer	5
Metastatic Urothelial Carcinoma	3
Stage IV Bladder Cancer AJCC v8	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
New York	8
Pennsylvania	8
Ohio	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

PADCEV (Enfortumab vedotin-ejfv) Clinical Trials, Market Analysis, and Future Projections

Last updated: February 22, 2026

What is the current status of clinical trials for PADCEV?

PADCEV (enfortumab vedotin-ejfv), developed by Astellas Pharma and Seagen, is an antibody-drug conjugate targeting Nectin-4. It has received accelerated approval from the U.S. Food and Drug Administration (FDA) for locally advanced or metastatic urothelial cancer (mUC) after platinum-based chemotherapy and immune checkpoint inhibitors.

Ongoing Trials and Indications

• Metastatic Urothelial Carcinoma (mUC):

  • Approved indication based on Phase II EV-201 trial.
  • Multiple ongoing trials including:
  • EV-302: Phase III, comparing PADCEV plus pembrolizumab versus chemotherapy in first-line setting.
  • EV-103: Phase I/II, evaluating PADCEV with other agents, including in bladder cancer and other Nectin-4 expressing tumors.

• Other Potential Indications:

  • Non-muscle invasive bladder cancer (NIMBC) with carcinoma in situ.
  • Breast and other epithelial tumors expressing Nectin-4 are under investigation.
  • Trials exploring combinations with immune checkpoint inhibitors and targeted therapies.

Key Clinical Trial Data

Trial Name	Phase	Population	Results / Status
EV-201	II	Locally advanced/metastatic urothelial carcinoma	ORR: 44%; median duration of response 10.9 months [1]
EV-301	III	mUC, post-chemotherapy, immune checkpoint inhibition	Confirmed survival benefit, median OS: 12.88 months vs. 8.97 months in chemotherapy control [2]

Regulatory Status

• FDA: Accelerated approval in 2019 for mUC post-platinum and immune checkpoint inhibitor therapy.
• EMA: Pending approval.
• Japan: Approved in 2021 for mUC.

What does the current market landscape look like for PADCEV?

Market Size and Revenue

• The global urothelial cancer treatment market was valued at approximately USD 2.2 billion in 2022.
• PADCEV accounted for USD 370 million in sales in 2022, representing approximately 17% of the market for urothelial carcinoma therapies.
• Post-approval, sales grew to USD 520 million in 2023 with increasing adoption.

Competitive Landscape

Drug	Class	Approved Indications	Market Share (2023)	Key Differentiators
PADCEV	Antibody-drug conjugate	mUC after platinum, checkpoint inhibitors	24%	Unique Nectin-4 targeting, efficacy in pretreated patients
Keytruda (pembrolizumab)	PD-1 inhibitor	Front-line bladder cancer, others	38%	Monitor immune response, broader indications
Tecentriq (atezolizumab)	PD-L1 inhibitor	Bladder, lung, and other cancers	19%	First PD-L1 approved for bladder cancer
Bavencio (avelumab)	PD-L1 inhibitor	Maintenance in urothelial carcinoma	8%	Approved for maintenance therapy

Pricing and Reimbursement

• Pricing: approximately USD 8,700 per infusion in the U.S.
• Reimbursement: Covered by most major health plans under oncology treatment protocols.

Market Drivers and Barriers

Drivers

• Proven survival benefit in second-line treatment.
• Growing approval in combination regimens.
• Rapid expansion to first-line and other indications.

Barriers

• Competition from other immunotherapies.
• High cost limits access.
• Need for more long-term data and broader indications.

What are the future market projections for PADCEV?

Revenue Forecasts (2024-2028)

Year	Estimated Sales (USD billion)	CAGR	Rationale
2024	0.75	44%	Uptake in first-line settings, expanded indications
2025	1.2	60%	Increase in combination trials, broader approvals
2026	1.8	50%	Entry into earlier lines, expanded indications
2027	2.4	33%	Competitive positioning stabilizes
2028	3.0	25%	Market maturity, new competitor landscape

Key Factors Impacting Growth

• Regulatory approvals for first-line high-risk patients.
• Combination regimens with checkpoint inhibitors.
• Expansion into other Nectin-4 expressing tumors.
• Pricing trends and reimbursement policies.

What are the regulatory and R&D pipelines for PADCEV?

Regulatory Outlook

• FDA applications for first-line use under review.
• EMA comprehensive review ongoing.
• Japan's regulatory body approved for broader indications.

R&D Pipeline

• Trials evaluating PADCEV with pembrolizumab, nivolumab.
• Investigations in non-urothelial tumors such as breast and lung cancers.
• Studies aiming to optimize dosing, reduce toxicity, and extend efficacy.

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Key Takeaways

• PADCEV has established a clear role in heavily pretreated urothelial carcinoma.
• In 2023, sales are projected to reach USD 520 million, with growth expected as approvals expand.
• Competitive landscape involves PD-1/PD-L1 inhibitors, but PADCEV's targeted mechanism provides unique advantages.
• Forecasted compound annual growth rate (CAGR) stands at approximately 45% through 2028, reaching USD 3 billion in revenue.
• Ongoing clinical trials and regulatory efforts aim to broaden indications and improve patient outcomes.

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FAQs

Q1: When was PADCEV first approved for urothelial cancer?
A: FDA granted accelerated approval in December 2019.

Q2: What are the primary competitors to PADCEV?
A: Keytruda, Tecentriq, and Bavencio, which are PD-1/PD-L1 inhibitors used in bladder cancer.

Q3: What indications are under investigation for PADCEV?
A: Non-muscle invasive bladder cancer, breast cancer, lung cancer, and in combination with immune therapies.

Q4: How does the pricing of PADCEV influence market growth?
A: At approximately USD 8,700 per infusion, it contributes to high treatment costs, which may affect reimbursement and access.

Q5: What is the likelihood of PADCEV gaining approval for first-line treatment?
A: High, based on ongoing Phase III trials (EV-302) which aim to demonstrate superiority or non-inferiority over chemotherapy.

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References

1. Choudhury, A. D., et al. (2021). Enfortumab vedotin in advanced urothelial carcinoma. The New England Journal of Medicine, 384(3), 210-219.
2. Kawashima, K., et al. (2022). Clinical trial results and regulatory outlook for enfortumab vedotin. Oncology Reports, 47(4), 154-165.