This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma.
This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.

Start Date20 Jun 2026

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

NCT07346053

/ Not yet recruitingPhase 3IIT

CHRONO-EVP: Time-of-day Dependent Administration of Enfortumab Vedotin and Pembrolizumab (EV/P) in Advanced Bladder Cancer

The goal of this clinical trial is to learn if the timing of treatments plays a role in how effective the standard-of-care drugs enfortumab vedotin and pembrolizumab (EV/P) works to treat adults with advanced bladder cancer. The trial will also learn if time-of-day reduces EV/P side-effects.
Researchers will compare EV/P given in the morning (before 11:30am) vs in the afternoon (after 1:30pm), to see if circadian rhythm effects how EV/P works to treat advanced bladder cancer.
Participants will be randomized in Arm A or Arm B to receive drugs EV/P either in the morning (Arm A) or afternoon (Arm B) as part of their standard-of-care treatment for advanced bladder cancer. Participants will:
* Visit the clinic either in the morning (Arm A) or afternoon (Arm B) to receive EV/P treatment as part of their regular medical care for advanced bladder cancer
* Frequency of visits will follow standard-of-care guidelines
* Participants will be followed-up by the study team for up to 24 months.

Start Date01 May 2026

Sponsor / Collaborator

British Columbia Cancer Agency

[+1]

NCT07139977

/ Not yet recruitingPhase 2IIT

Open-Label Phase II Trial of Enfortumab Vedotin in Recurrent or Persistent Endometrial Carcinoma

This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous treatments, including immunotherapy. The goal is to see how well the drug works and how safe it is. Patients will be treated for up to one year and followed over time to monitor their health and response to the treatment.

Start Date01 Apr 2026

Sponsor / Collaborator

Medical College of Wisconsin

[+1]

100 Clinical Results associated with Enfortumab Vedotin-ejfv

100 Translational Medicine associated with Enfortumab Vedotin-ejfv

100 Patents (Medical) associated with Enfortumab Vedotin-ejfv

1,071

Literatures (Medical) associated with Enfortumab Vedotin-ejfv

01 Jun 2026·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Neoadjuvant Systemic Therapy in Kidney and Bladder Cancer: Current Evidence and Emerging Paradigms

Review

Author: Bangs, Rick ; Tipirneni, Asha ; Guercio, Brendan J. ; McKay, Rana R.

Neoadjuvant systemic therapy has emerged as a strategy to improve outcomes in high-risk localized genitourinary malignancies. In bladder cancer, neoadjuvant cisplatin-based chemotherapy with or without immunotherapy is standard of care, with pathologic complete response (pCR) serving as a validated surrogate for survival after chemotherapy and a promising potential surrogate for survival after other neoadjuvant treatments like immunotherapy. Enfortumab vedotin and immune checkpoint inhibitors have expanded treatment options, with ongoing studies evaluating novel adjuvant approaches tailored to patients' postoperative circulating tumor DNA. In renal cell carcinoma (RCC), the field is nascent, no approved neoadjuvant regimens exist, and treatment outside clinical trials is not recommended. Early trials of tyrosine kinase inhibitor monotherapy showed limited pathologic responses, while immune checkpoint inhibitor-based combinations have demonstrated feasibility, safety, and the capacity to induce pathologic responses including pCR. Critical gaps remain in both diseases. In RCC, standardized pathologic response criteria are lacking, and surrogacy between pathologic end points and long-term outcomes has not been established. In bladder cancer, optimal post-pCR management and integration of novel agents require further study. Emerging technologies, particularly artificial intelligence (AI)–driven digital pathology, offer potential to enhance diagnosis, refine prognostic stratification, and predict treatment response, although prospective validation across diverse populations is needed. This chapter examines neoadjuvant therapy and pathologic response assessment in RCC and bladder cancer, explores pathologic biomarker development including AI applications, and highlights future directions to optimize therapeutic sequencing and outcomes.

01 May 2026·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Real-world treatment sequences and overall survival in metastatic bladder cancer: The STATES-Bladder study

Article

Author: Barbe-Richaud, Jean-Baptiste ; Maillet, Denis ; Baudry, Edwige ; Pierard, Laure ; Amrane, Karim ; Moinard-Butot, Fabien ; Barthélémy, Philippe

BACKGROUND AND PURPOSE:

The treatment landscape for metastatic urothelial carcinoma (mUC) has rapidly evolved with immune checkpoint inhibitors (ICI), FGFR-targeted therapies, antibody-drug conjugates, and more recently first-line enfortumab vedotin (EV) plus pembrolizumab. In many countries, this combination is not yet available, and the standard of care (SOC) remains platinum-based chemotherapy (PBC) followed by ICI. Real-world data on treatment sequencing and attrition across therapy lines in unselected populations are limited.

MATERIALS AND METHODS:

We analyzed patients with mUC treated between January 2020 and December 2023 across 4 French oncology centers. Eligible patients had received at least 1 cycle of PBC. Overall survival (OS), treatment sequences, and attrition rates were assessed. Survival was estimated using Kaplan-Meier methods.

RESULTS:

A total of 180 patients were included (median age 72 years; 81% male; 84% urothelial carcinoma). All received first-line PBC; 127 (71%) were non-progressive and eligible for avelumab maintenance, but 24 (19%) did not receive it. Only 54 patients (64%) received second-line therapy, and 45 (25%) reached third-line treatment. Median OS was 22.4 months (95% CI: 17.2-26.7). Patients receiving PBC followed by avelumab maintenance achieved a median OS of 29.0 months, compared with 15.6 months for not reponsders PBC patients. Patients with ECOG 2 to 3 (n = 36) had poor outcomes (median OS 7.2 months vs. 26.4 months for ECOG 0-1; P < 0.001).

CONCLUSIONS:

This study confirms the real-world effectiveness of contemporary treatment sequences, highlights significant attrition between therapy lines, and underscores the need for upfront use of effective agents, particularly in patients with poor performans status.

01 Apr 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Real-world evidence for 10 oncology drugs approved in the last 5 years: A comprehensive narrative synthesis

Review

Author: Oggionni, Emanuela ; Balconi, Elena ; Parati, Maria Chiara ; Rossitto, Mauro ; Petrò, Daniela ; Petrelli, Fausto ; Ghilardi, Mara ; Colombo Zefinetti, Lara ; Dottorini, Lorenzo ; Borgonovo, Karen ; Castelli, Emanuela ; Dognini, Giuseppina ; Zambelli, Alberto

IMPORTANCE:

Randomized controlled trials (RCTs) establish the efficacy of new oncology drugs but often exclude older adults, patients with comorbidities, and individuals with poorer performance status. Real-world evidence (RWE) is therefore essential to determine whether trial benefits translate to the broader populations treated in routine practice.

OBJECTIVE:

To synthesize contemporary RWE on the effectiveness and safety of ten oncology drugs approved between 2020 and 2025 for solid tumors, focusing on studies with ≥ 100 patients to maximize robustness and generalizability.

EVIDENCE REVIEW:

A systematic search of PubMed/MEDLINE, Embase, Scopus, Web of Science, and major conference proceedings (ASCO, ESMO, AACR) identified observational cohorts, registries, expanded-access programs, and claims-based studies published from January 2020 to January 2025.

FINDINGS:

Twenty studies (N > 3400) met inclusion criteria: breast cancer (9), lung cancer (7), urothelial carcinoma (3), and endometrial cancer (1). In breast cancer, sacituzumab govitecan reproduced ASCENT outcomes (ORR 27-30 %; PFS 4.8-5.2 months), trastuzumab deruxtecan achieved ORRs near 70 % in HER2-positive disease and median PFS 7.5 months in HER2-low cohorts, and elacestrant showed real-world time-to-next-treatment of 7.9-10.8 months in ESR1-mutant ER+ /HER2 - disease. In NSCLC, sotorasib and adagrasib demonstrated ORRs of ∼28-34 % and PFS 3.5-6 months, selpercatinib provided durable disease control, and MET inhibitors (capmatinib, tepotinib) yielded PFS around 6-7 months. In urothelial carcinoma, enfortumab vedotin produced ORRs of 31-73 % across datasets. In endometrial cancer, dostarlimab generated highly durable responses in dMMR/MSI-H disease.

CONCLUSIONS:

RWE confirms the effectiveness and safety of multiple recently approved oncology drugs reinforcing the external validity of RCTs.

629

News (Medical) associated with Enfortumab Vedotin-ejfv

24 Mar 2026

·www.biospace.com

VivoSim Releases Antibody Drug Conjugate (ADC) Data Showing Power to Detect ADC Toxicity and Guide Design of Safer ADCs

ADCs are a major new market; Company demonstrates ability to discern antibody toxicity from payload toxicity and show differential linker chemistry toxicity SAN DIEGO, March 24, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAMs) for preclinical safety, today announced at the Society of Toxicology (“SOT”) meeting in San Diego, CA, that its NAMkind™ liver and NAMkind™ Intestine models have been validated for predicting toxicity and side effect profiles of antibody drug conjugates (ADCs). When considering the hundreds of ADCs in development across the globe, the potential for off-target toxicity due to their common use in oncology to deliver cytotoxic payloads, and a lack of current available scientific solutions to separate anticancer activity from unwanted cytotoxicity, the Company believes that the use of NAMkind™ models becomes a powerful tool to use in conjunction with existing methods to select and improve the best ADC candidates for drug development. Testing of approved ADC therapies in NAMkind™ models shows close correlation with clinical results VivoSim NAMkind™ liver model was shown to clearly see the toxicity of liver toxic ADCs such as gemtuzumab ozogomicin and clearly showed drugs with low liver toxicity such as enfortumab vedotin as lacking liver toxicity. Issues of linker cleavage and target engagement can be studied, as differential toxicity between drugs like trastuzumab emtansine and trastuzumab deruxtecan were demonstrated with strong comparability to clinical outcomes. NAMkind™ intestine models were also validated with ADCs and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload. “These ADC toxicity results show a close correlation to clinical safety outcomes,” said Amar Sethi, Chief Scientific Officer at VivoSim. “We consider these models validated for ADC use and think that our partners may be able to screen out toxicities during lead candidate optimization or earlier stages, which may result in greater success in the clinic at eliminating cancers using drugs with limited side effect pro ” he continued. “With clearly demonstrated success in detecting differential toxicity in ADCs, our NAMkind models are now well-established at the cutting edge of the field,” said Keith Murphy, VivoSim’s Executive Chairman. “We continue to trailblaze into new modalities and empower our partners in new ways.” NAMKind™ liver and small intestine toxicology services are now available in the US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs. About VivoSim Labs VivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies (“NAM”) models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA”) announcement on April 10, 2025 to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit Forward-Looking Statements Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding NAMKind™, including the use of NAMkind™ models in conjunction with existing methods to select and improve the best ADC candidates for drug development and the Company’s models being well-established at the cutting edge of the field; VivoSim’s partners’ ability to screen out toxicities during lead candidate optimization or earlier stages, which may result in greater success in the clinic at eliminating cancers using drugs with limited side effect pro VivoSim’s ability to trailblaze into new modalities and empower their partners in new ways; and the Company’s scaling capacity to support expanding global demand and development needs. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 5, 2025, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 11, 2026. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events. Contact(s): Investor Relations info@vivosim.ai VivoSim Labs, Inc.

ADC

23 Mar 2026

·newsroom.astellas.com

EMA Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) plus Keytruda® (pembrolizumab) in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer

TOKYO, March 23, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Medicines Agency (EMA) has validated for review a Type II Variation Application for PADCEVTM (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor, as neoadjuvant treatment (before surgery), and then continued after radical cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-containing chemotherapy. The application is supported by results from the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15), which demonstrated that neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab reduced the risk of tumor recurrence, progression, or death by 47% and risk of death by 35% compared with standard of care neoadjuvant gemcitabine and cisplatin chemotherapy.1 At the time of surgery, 55.8% of patients treated with the combination achieved a pathological complete response (pCR rate), compared with 32.5% of patients treated with neoadjuvant chemotherapy.1 Efficacy benefits were generally consistent across all pre-defined subgroups, including age, gender, PD-L1 status, clinical stage and geographic region.1 The safety profile of the combination was consistent with prior experience, and no new safety signals were observed.1 In Europe, bladder cancer is diagnosed in more than 224,000 people annually,2 with MIBC representing approximately 30% of cases.3 Despite surgery, approximately half of patients with MIBC experience recurrence.4 In December 2025, the EMA also validated a Type II Variation Application for the combination as neoadjuvant treatment, followed by adjuvant treatment after radical cystectomy, for adult cisplatin-ineligible patients with MIBC. Regulatory reviews for both the cisplatin-eligible and cisplatin-ineligible populations are ongoing. Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2026. About PADCEV (enfortumab vedotin) PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.5 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).5 Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and bera hyaluronidase alfa-pmph is approved as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the European Union, the combination is approved for the treatment of adult patients with la/mUC who are eligible for platinum-containing chemotherapy. Enfortumab vedotin is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. About the EV-304/KEYNOTE-B15 Trial The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms.6 Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab split before and after surgery. The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on blinded independent central review (BICR) or death due to any cause. Key secondary endpoints include OS and pCR rate.6 For more information on the global EV-304 trial, go to clinicaltrials.gov. About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com. About the Pfizer, Astellas and MSD Collaboration Seagen and Astellas previously entered a clinical collaboration agreement with MSD to evaluate the combination of Seagen’s and Astellas’ PADCEV (enfortumab vedotin) and MSD’s KEYTRUDA (pembrolizumab) in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of MSD, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Contacts for inquiries or additional information: Astellas Pharma Inc. Corporate Communications +81-3-3244-3201 References 1. Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer who are eligible for cisplatin: randomized, open-label, phase 3 KEYNOTE-B15 study. Abstract #LBA630. 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Congress. 2. European Association of Urology. EAU Guidelines on Muscle-invasive and Metastatic Bladder Cancer – Epidemiology, Aetiology and Pathology. Available at: https://uroweb.org/guidelines/muscle-invasive-and-metastatic-bladder-cancer/chapter/epidemiology-aetiology-and-pathology. Last Accessed: March 2026 3. Bladder Cancer Awareness Network. What is Muscle Invasive Bladder Cancer? Available at: https://bcan.org/what-is-muscle-invasive-bladder-cancer/. Last Accessed: Last Accessed: March 2026 4. Squires P, Cook EE, Song Y, Wang C, Zhang A, Seshasayee SM, Rogiers A, Li H, Mamtani R. Treatment Patterns, Disease Recurrence, and Overall Survival in Patients with Muscle-Invasive Bladder Cancer after Radical Cystectomy: A Population-Level Claims-Based Analysis. Clinical Genitourinary Cancer. 2025 Nov;102466. https://doi-org.sutd.idm.oclc.org/10.1016/j.clgc.2025.102466. 5. Challita-Eid PM., et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res 2016;76(10):3003-13. 6. National Institute of Health. National Library of Medicine. Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) (KEYNOTE-B15). ClinicalTrials.gov identifier: NCT04700124. Available at: https://www.clinicaltrials.gov/study/NCT04700124. Last Accessed: March 2026

Clinical ResultPhase 3Drug ApprovalAcquisitionASCO

20 Mar 2026

·allsci.com

Pfizer calls halt to Phase I development of Seagen-acquired CD228 ADC

Pfizer has terminated its Phase I PF-08046031 clinical trial in adults with advanced melanoma and other solid tumors, according to an update on ClinicalTrials.gov (NCT06799533). The decision ends clinical development of the company’s sole CD228-directed antibody-drug conjugate, a molecule inherited through its USD 43 billion acquisition of Seagen in 2023. Only 11 participants were enrolled before the study was stopped, and no results have been posted to the registry. The clinicaltrials.gov listing indicates the decision was taken for strategic reasons with no safety or efficacy concerns. PF-08046031, formerly designated SGN-CD228A under Seagen’s pipeline, is a humanized IgG1 monoclonal antibody conjugated to approximately four molecules of monomethyl auristatin E (MMAE) via a cleavable vedotin-type linker. The ADC was designed to bind CD228 — also known as melanotransferrin — on the surface of tumor cells, internalize, and release its cytotoxic payload within the lysosome, disrupting microtubule polymerization and triggering G2/M cell cycle arrest. CD228 is expressed at elevated levels in melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and esophageal cancer, with limited expression in normal tissues. The study was an open-label, single-arm, sequential assignment trial designed to assess dosing levels in patients with metastatic or unresectable cutaneous melanoma previously treated with an anti-PD-1/PD-L1 regimen. The trial included dose-escalation and dose-optimization cohorts in melanoma, with a planned expansion to also include patients with non-small cell lung cancer, head and neck squamous cell carcinoma, and esophageal cancer. Context from Pfizer’s broader pipeline activity offers one plausible frame. Following the Seagen acquisition, Pfizer undertook a series of portfolio rationalization exercises, discontinuing 11 programs in late 2024, with additional cuts following shortly after. A separate earlier-stage trial of SGN-CD228A (NCT04042480) was also terminated, leaving no active clinical studies for this molecule. According to public data, Pfizer retains an interest in CD228 in the form of PF-08046049 (SGN-BB228), a CD228 x 4-1BB bispecific currently under Phase I study (NCT05571839), also being targeted towards melanoma. For Pfizer’s broader oncology portfolio, the loss is one of several Seagen-inherited assets shed as the company narrows its ADC strategy. Pfizer retains other ADC programs built on the vedotin/MMAE platform, including the marketed products brentuximab vedotin (Adcetris) and enfortumab vedotin (Padcev), as well as tisotumab vedotin (Tivdak). Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 1AcquisitionADC

100 Deals associated with Enfortumab Vedotin-ejfv

External Link

KEGG	Wiki	ATC	Drug Bank
-	Enfortumab Vedotin-ejfv	L01XC	DB13007

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Muscle Invasive Bladder Carcinoma	United States	Astellas Pharma US, Inc.	21 Nov 2025
Unresectable Urothelial Carcinoma	European Union	Astellas Pharma Europe Ltd.	24 Sep 2024
Unresectable Urothelial Carcinoma	Iceland	Astellas Pharma Europe Ltd.	24 Sep 2024
Unresectable Urothelial Carcinoma	Liechtenstein	Astellas Pharma Europe Ltd.	24 Sep 2024
Unresectable Urothelial Carcinoma	Norway	Astellas Pharma Europe Ltd.	24 Sep 2024
Locally Advanced Urothelial Carcinoma	European Union	Astellas Pharma Europe Ltd.	13 Apr 2022
Locally Advanced Urothelial Carcinoma	Iceland	Astellas Pharma Europe Ltd.	13 Apr 2022
Locally Advanced Urothelial Carcinoma	Liechtenstein	Astellas Pharma Europe Ltd.	13 Apr 2022
Locally Advanced Urothelial Carcinoma	Norway	Astellas Pharma Europe Ltd.	13 Apr 2022
Metastatic urothelial carcinoma	European Union	Astellas Pharma Europe Ltd.	13 Apr 2022
Metastatic urothelial carcinoma	Iceland	Astellas Pharma Europe Ltd.	13 Apr 2022
Metastatic urothelial carcinoma	Liechtenstein	Astellas Pharma Europe Ltd.	13 Apr 2022
Metastatic urothelial carcinoma	Norway	Astellas Pharma Europe Ltd.	13 Apr 2022
Transitional Cell Carcinoma	United States	Astellas Pharma US, Inc.	18 Dec 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Transitional cell carcinoma urethra	Phase 3	United States	Seagen, Inc.	26 Aug 2020
Transitional cell carcinoma urethra	Phase 3	China	Seagen, Inc.	26 Aug 2020
Transitional cell carcinoma urethra	Phase 3	Japan	Seagen, Inc.	26 Aug 2020
Transitional cell carcinoma urethra	Phase 3	Argentina	Seagen, Inc.	26 Aug 2020
Transitional cell carcinoma urethra	Phase 3	Australia	Seagen, Inc.	26 Aug 2020
Transitional cell carcinoma urethra	Phase 3	Belgium	Seagen, Inc.	26 Aug 2020
Transitional cell carcinoma urethra	Phase 3	Canada	Seagen, Inc.	26 Aug 2020
Transitional cell carcinoma urethra	Phase 3	Czechia	Seagen, Inc.	26 Aug 2020
Transitional cell carcinoma urethra	Phase 3	Denmark	Seagen, Inc.	26 Aug 2020
Transitional cell carcinoma urethra	Phase 3	France	Seagen, Inc.	26 Aug 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EV-302/KEYNOTE-A39 (AACR2026)	Phase 3	Transitional Cell Carcinoma Nectin-4 \| PD1 \| PDL-1 ... View more	100	Enfortumab vedotinPembrolizumabPadeliporfin VTP + Enfortumab vedotinPembrolizumabPadeliporfin VTPin + Enfortumab vedotinPembrolizumabPadeliporfin VTP	gvylfpwczh(zsgqbdkqoi) = ghwgqgbpod fiizjlyonm (kibdzzjvyi )	Positive	21 Apr 2026
NCT04700124 (KEYNOTE-B15, ASCO_GU2026) Manual	Phase 3	Muscle Invasive Bladder Carcinoma Neoadjuvant \| Adjuvant	808	Enfortumab vedotin + Pembrolizumab	vrpbbjkmhn(qsrvsysrfw) = toatbovnlx uplrcnxspc (hhjevgrzro ) View more	Positive	26 Feb 2026
				Gemcitabine + Cisplatin	vrpbbjkmhn(qsrvsysrfw) = jpcltekbyr uplrcnxspc (hhjevgrzro ) View more
ASCO_GU2026	Not Applicable	Advanced Urothelial Carcinoma First line	456	pembrolizumabenfortumab vedotin + pembrolizumabenfortumab vedotin (Upfront dose reduction)	fssehzkwme(kgobsiouul) = ambeqgzjiq ynzkralreh (frbbjblwnh ) View more	Positive	26 Feb 2026
				pembrolizumabenfortumab vedotin + pembrolizumabenfortumab vedotin (No upfront dose reduction)	fssehzkwme(kgobsiouul) = khmggzqxxi ynzkralreh (frbbjblwnh ) View more
ASCO_GU2026	Not Applicable	Transitional Cell Carcinoma	27	Enfortumab vedotin plus pembrolizumab (EVP)	dmlzaymnqy(rtgnhkxvlg) = bbtdnuhuem remdoynqjr (nwyeixrock ) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Advanced Urothelial Carcinoma First line	1,672	Enfortumab vedotin plus pembrolizumab	rblxuzqdsx(qwjdzvwxhk) = enbfkqkqlf wklrueixse (qhvpiqndjv ) View more	Positive	26 Feb 2026
				gemcitabine-platinum	rblxuzqdsx(qwjdzvwxhk) = idxlakiund wklrueixse (qhvpiqndjv ) View more
ASCO_GU2026	Not Applicable	Metastatic urothelial carcinoma First line	535	Enfortumab vedotin + pembrolizumab	wqihmtnmxv(vqgbmfyujr) = qrosdedfpi udfdkzftlj (olrjxsfpfb, 5 - 7.5) View more	Positive	26 Feb 2026
				Chemotherapy	wqihmtnmxv(vqgbmfyujr) = nxrhdchfji udfdkzftlj (olrjxsfpfb, 1.9 - 2.9) View more
ASCO_GU2026	Not Applicable	Metastatic urothelial carcinoma	72	Enfortumab vedotin	dkcrhedzsh(xoamwecrfs) = ssguymwkka mheyuubxkc (mmpmqgmdqx ) View more	Positive	26 Feb 2026
				Enfortumab vedotin + pembrolizumab	dkcrhedzsh(xoamwecrfs) = vhjkuickiw mheyuubxkc (mmpmqgmdqx ) View more
NCT04223856 (EV-302, ASCO_GU2026)	Phase 3	Metastatic urothelial carcinoma First line	886	Enfortumab vedotin plus pembrolizumab	zycrrkeqju(mvomnnxfwv) = frzohoykke wodajofeew (qtvrkatfpe, 17.8 - NE) View more	Positive	26 Feb 2026
				Chemotherapy (gemcitabine + cisplatin/carboplatin)	zycrrkeqju(mvomnnxfwv) = mutzguvify wodajofeew (qtvrkatfpe, 6.2 - 9.0) View more
ASCO_GU2026	Not Applicable	Advanced Urothelial Carcinoma First line	745	Enfortumab vedotin + Pembrolizumab	gwnktukakr(dbhsozavcc) = nkrzvxotxm mvfryqkpxc (tzsrzqluzs, 15 - 21) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Transitional Cell Carcinoma	157	Enfortumab vedotin (pre-EV steroids)	ogyftdwlhq(nmwcwncvvw) = yjcvciublw genjxuhbio (envkdibiqa ) View more	Negative	26 Feb 2026
				Enfortumab vedotin (no pre-EV steroids)	ogyftdwlhq(nmwcwncvvw) = sczmwzgjks genjxuhbio (envkdibiqa ) View more

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