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
Urothelial Cancer	5
Bladder Cancer	4
Metastatic Urothelial Carcinoma	3
Urinary Bladder Neoplasms	2

Condition MeSH

Condition MeSH for PADCEV
Intervention	Trials
Urinary Bladder Neoplasms	11
Carcinoma	10
Carcinoma, Transitional Cell	10
Ureteral Neoplasms	7

Clinical Trial Locations for PADCEV

Trials by Country

Trials by Country for PADCEV
Location	Trials
United States	183
Japan	34
France	25
Russian Federation	20
Spain	17

Trials by US State

Trials by US State for PADCEV
Location	Trials
California	10
Texas	9
Pennsylvania	8
Ohio	8
New York	8

Clinical Trial Progress for PADCEV

Clinical Trial Phase

Clinical Trial Phase for PADCEV
Clinical Trial Phase	Trials
Phase 3	5
Phase 2/Phase 3	1
Phase 2	7

Clinical Trial Status

Clinical Trial Status for PADCEV
Clinical Trial Phase	Trials
Recruiting	11
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 Global Development, Inc.	5

Sponsor Type

Sponsor Type for PADCEV
Sponsor	Trials
Industry	39
Other	6
NIH	2

PADCEV: A Groundbreaking Treatment for Bladder Cancer - Clinical Trials, Market Analysis, and Projections

Introduction to PADCEV

PADCEV, also known as enfortumab vedotin-ejfv, is a first-in-class antibody-drug conjugate (ADC) that targets Nectin-4, a protein highly expressed on the surface of bladder cancer cells. Developed by Astellas Pharma and Seagen (now part of Pfizer), PADCEV has been making significant strides in the treatment of advanced bladder cancer.

Clinical Trials and Efficacy

Initial Approval and Trial Results

PADCEV was initially approved by the FDA under the accelerated approval program based on an open-label, multicenter clinical trial involving 125 adults with locally advanced or metastatic urothelial cancer. These patients had previously received treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. The trial showed that 44% of patients experienced complete or partial tumor shrinkage, with a median duration of response of about 7.6 months[1].

Combination Therapy with Keytruda

Recent clinical trials have focused on the combination of PADCEV with Merck's PD-1 inhibitor, Keytruda (pembrolizumab). The EV-302 trial, which combined PADCEV with Keytruda, demonstrated a significant improvement in overall survival and progression-free survival compared to standard platinum-based chemotherapy. This combination nearly doubled the median overall survival and showed a life extension benefit that surpassed the pre-specified efficacy boundary at an interim analysis[2][3].

Durable Responses and Long-Term Benefits

The EV-201 and EV-103 trials provided further evidence of PADCEV's efficacy. The EV-201 trial showed that after a median follow-up of 16 months, many patients continued to benefit from PADCEV, with a confirmed objective response rate of 51% and a median duration of response of 13.8 months. The EV-103 trial, which combined PADCEV with Keytruda, demonstrated an objective response rate of 73.3% and a median progression-free survival of 12.3 months[4].

Market Analysis and Projections

Sales Performance and Growth

Astellas has seen a significant surge in sales for PADCEV, particularly following the FDA approval of the PADCEV-Keytruda combination for first-line treatment in cisplatin-ineligible patients. Sales of PADCEV increased by 68% year over year, reaching 55.6 billion yen ($374 million) over the last three quarters. This strong uptake has led Astellas to revise its sales forecast upwards, estimating peak sales between 400 billion to 500 billion Japanese yen ($2.7 billion to $3.4 billion)[5].

Market Expansion and Potential

The inclusion of the cisplatin-eligible population in the treatment regimen could nearly double the addressable market for PADCEV to over $5 billion worldwide. Analysts expect rapid adoption by physicians upon potential approval, further boosting the drug's market potential[2].

Regulatory Milestones and Partnerships

PADCEV received full FDA approval in 2021 for its use in second-line treatment for adults ineligible for cisplatin-based chemotherapy. The recent approval of the PADCEV-Keytruda combination for first-line treatment in both cisplatin-eligible and ineligible patients marks a significant milestone. This approval was granted five months ahead of the regulatory deadline, highlighting the drug's promising efficacy[3][5].

Impact on Clinical Practice

Changing Treatment Paradigms

The combination of PADCEV with Keytruda has the potential to be practice-changing, offering a new standard of care for first-line metastatic bladder cancer. According to Seagen’s R&D head, Roger Dansey, M.D., this study could significantly alter treatment practices, providing a platinum-free combination that reduces the risk of death by 53% over chemotherapy[2][4].

Patient Benefits

For patients with advanced urothelial cancer, especially those who are not eligible for cisplatin-based chemotherapy, PADCEV offers a viable and effective treatment option. The durable responses and long-term benefits observed in clinical trials translate into improved quality of life and extended survival for these patients.

Side Effects and Safety Profile

While PADCEV has shown significant efficacy, it is not without side effects. Common adverse reactions include fatigue, peripheral neuropathy, and skin reactions. However, the overall safety profile has been manageable, allowing for continued treatment in most patients[1].

Future Directions and Ongoing Trials

Ongoing Studies and Cohorts

The EV-202 trial is an ongoing, multi-cohort study investigating enfortumab vedotin alone and in combination with pembrolizumab in various patient populations, including those with previously untreated recurrent/metastatic head and neck squamous cell carcinoma. These studies aim to further expand the therapeutic indications for PADCEV[3].

Regulatory Discussions and Approvals

Astellas and Pfizer are actively discussing the results of the EV-302 trial with regulators to expedite the approval process for the PADCEV-Keytruda combination in broader patient populations. This proactive engagement is expected to facilitate quicker access to this life-saving treatment for more patients[2][3].

Key Takeaways

• Efficacy in Clinical Trials: PADCEV has demonstrated significant efficacy in clinical trials, both as a monotherapy and in combination with Keytruda.
• Market Growth: Strong sales performance and revised sales forecasts indicate a promising market future for PADCEV.
• Changing Treatment Paradigms: The PADCEV-Keytruda combination is poised to become a new standard of care for first-line metastatic bladder cancer.
• Patient Benefits: Durable responses and long-term benefits offer improved outcomes for patients with advanced urothelial cancer.
• Future Directions: Ongoing trials and regulatory discussions are expected to expand the therapeutic indications for PADCEV.

FAQs

What is PADCEV and how does it work?

PADCEV (enfortumab vedotin-ejfv) is an antibody-drug conjugate that targets Nectin-4, a protein highly expressed on bladder cancer cells, delivering a cytotoxic payload directly to the cancer cells.

What are the key clinical trial results for PADCEV?

Clinical trials have shown that PADCEV, both alone and in combination with Keytruda, significantly improves overall survival and progression-free survival in patients with advanced urothelial cancer.

What is the current market projection for PADCEV?

Astellas estimates peak sales for PADCEV between $2.7 billion and $3.4 billion, driven by strong sales performance and the approval of the PADCEV-Keytruda combination.

How does the combination of PADCEV with Keytruda impact treatment?

The combination of PADCEV with Keytruda has the potential to be practice-changing, offering a new standard of care for first-line metastatic bladder cancer by reducing the risk of death by 53% over chemotherapy.

What are the common side effects of PADCEV?

Common side effects include fatigue, peripheral neuropathy, and skin reactions, although the overall safety profile is manageable.

What ongoing trials are there for PADCEV?

The EV-202 trial is an ongoing study investigating enfortumab vedotin alone and in combination with pembrolizumab in various patient populations, including those with head and neck squamous cell carcinoma.

Sources

1. FDA Drug Trials Snapshots: PADCEV - FDA
2. Seagen and Astellas' Padcev, in Keytruda combo, delivers 'practice-changing' first-line win - FiercePharma
3. PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA (pembrolizumab) Approved by FDA - PR Newswire
4. Updated Results from Two Trials of PADCEV® (Enfortumab Vedotin-Ejfv) in Patients With Locally Advanced or Metastatic Urothelial Cancer - UroToday
5. Astellas' sales expectations are up for Padcev, down for Veozah - FiercePharma

Last updated: 2025-01-02