Enfortumab and pembrolizumab in advanced urothelial cancer

A 68-year-old man comes to the oncology clinic with urothelial carcinoma of the bladder with lymph node and lung metastases. He has not received systemic treatment for advanced disease. He has had type 2 diabetes for twelve years, takes metformin, and his last glycated hemoglobin was 7.4 percent. His estimated creatinine clearance is 52 mL/min, and he reports mild numbness in his toes, without limiting walking. He is active, takes care of the house and walks every day. His daughter asks whether there is something better than the chemotherapy her neighbor's father had a few years ago. The scene is fictional and was written for teaching.

This text uses the case as a clinical reasoning scenario for students and health professionals. It covers enfortumab vedotin with pembrolizumab, the combination that became the first line for locally advanced or metastatic urothelial carcinoma. The text explains the target, the studies, the status at the FDA and the EMA, the dose in the US label and the monitoring of skin, blood glucose, nerves, lungs, eyes and immune events. It does not replace your institution's protocol or the local label. If you play the case of the day on NEXO, you will recognize the challenge: deciding with clues that arrive in sequence.

Key points

• Enfortumab vedotin (brand name Padcev) is an antibody-drug conjugate against nectin-4 with the antimicrotubule agent MMAE.
• In the EV-302 study, the combination with pembrolizumab brought median overall survival to 31.5 months, versus 16.1 months with platinum chemotherapy.
• The US dose is 1.25 mg/kg, up to 125 mg, on days 1 and 8 of 21-day cycles, before pembrolizumab.
• The US label carries a boxed warning about severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Hyperglycemia, peripheral neuropathy, pneumonitis, ocular toxicity and immune events call for monitoring from the first cycle.
• The regulatory dates in this text were checked at the FDA and the EMA on October 24, 2026.

Why this is a reasoning scenario

For decades, the first line for metastatic urothelial carcinoma was platinum chemotherapy. The article on the CheckMate 901 study recalls that cisplatin chemotherapy produces a response in more than 40 percent of patients, with median overall survival of about 15 months, but durable responses are uncommon (van der Heijden and colleagues, 2023). The same article recalls that maintenance with avelumab is standard for those who do not progress during or soon after chemotherapy (van der Heijden and colleagues, 2023). The arrival of enfortumab vedotin with pembrolizumab changed that order, and this requires the clinician to review old habits.

The scenario is good for training because the decision has three layers. The first is choosing the right regimen for the disease. The second is reading the patient: diabetes, kidney function and a mild neuropathy that already exists. The third is building a monitoring plan that finds skin, blood glucose and nerve toxicity early. The post on signs, symptoms and history helps record the numbness in the feet before starting, and the post on clinical decision-making recalls that every test ordered must change a decision.

What the scene teaches

The scene trains six habits. The first is defining whether the patient is eligible for cisplatin or not. The second is measuring glycated hemoglobin and arranging glucose control. The third is grading the baseline neuropathy. The fourth is examining the skin and eyes before the first cycle. The fifth is explaining to the family which symptoms require contact on the same day. The sixth is knowing that the combination adds the toxicity of an antibody-drug conjugate to that of an immune checkpoint inhibitor.

What is not at stake

The text does not discuss the treatment of localized disease, surgery, radiotherapy or second-line therapies in detail. It also does not compare prices or access. The post on diagnostic uncertainty helps explain to the family what median survival means and what it does not promise for a particular patient.

Eligible or not for cisplatin

The US label defines ineligibility for cisplatin by at least one of these criteria: creatinine clearance below 60 mL/min, ECOG performance status 2 or worse, grade 2 or higher hearing loss, NYHA class III or IV heart failure or grade 2 or higher peripheral neuropathy (US Padcev label, 07/2026). The man in the scene has a clearance of 52 mL/min and would therefore be ineligible for cisplatin. In the first line, however, the combination is indicated for locally advanced or metastatic urothelial carcinoma with or without eligibility for cisplatin (US Padcev label, 07/2026).

Advanced urothelial carcinoma and nectin-4

A disease of older people

In EV-302, the median age was 69 years, 46 percent of patients were ineligible for cisplatin, 72 percent had visceral metastases and 22 percent had liver metastases (US Padcev label, 07/2026). It is a profile similar to that of the man in the scene. In the second-line EV-301 study, the median age was 68 years and 77.3 percent were men (Powles and colleagues, 2021). A Japanese real-world cohort with the combination in the first line had a median age of 75 years (Hara and colleagues, 2026).

What nectin-4 is

Nectin-4 is a cell adhesion protein. A 2025 review summarizes that, in bladder cancer, 83 percent of patients have some expression, 60 percent have moderate to high expression and 31 percent have high expression (Nikanjam and colleagues, 2025). The same review notes that the protein can be on the membrane or in the cytoplasm (Nikanjam and colleagues, 2025). This matters because the conjugate needs to bind to the surface protein to enter the cell.

When expression changes

A German study evaluated 137 primary tumors with corresponding metastases and found nectin-4 negative in 19.7 percent of primary tumors (Klümper and colleagues, 2023). In the metastases, the negative proportion was 39.4 percent (Klümper and colleagues, 2023). The authors propose biopsy of the metastasis to assess membrane nectin-4 before enfortumab vedotin and call for studies stratified by biomarker (Klümper and colleagues, 2023). Today, the US label does not require nectin-4 testing among the conditions of use (US Padcev label, 07/2026). The post about differential diagnosis helps to remember that a poor response can have several explanations, including the biology of the target.

How enfortumab vedotin works

The label describes enfortumab vedotin as a conjugate of a human antibody against nectin-4, a cell surface adhesion protein, with MMAE, a microtubule inhibitor (US Padcev label, 07/2026). The EMA summarizes that the antibody binds to this protein to enter the cancer cell, and that inside it MMAE dismantles the cell's internal skeleton and causes its death (EMA, Padcev page). Pembrolizumab is an antibody that blocks the PD-1 receptor and prevents the tumor from switching off immune system cells (EMA, Keytruda page). In the combination, one agent kills cells directly and the other releases the brake on the immune system.

Why the toxicity is so typical

A review on the toxicity of approved conjugates notes that DNA-damaging agents have more blood and liver toxicity, while microtubule inhibitors, such as auristatins, cause more peripheral neuropathy and ocular toxicity (Ballestín and colleagues, 2025). MMAE is an auristatin. Nectin-4 also exists in keratinocytes of the epidermis and in skin appendages, which helps to understand why skin reactions are so frequent (Lacouture and colleagues, 2022). A review on skin events notes that they usually appear in the first cycle, as red, scaly and itchy papules, mainly in folds, flexural areas and extremities (Lacouture and colleagues, 2022).

What comes from pembrolizumab

A review of the management of adverse events of the combination recalls that both agents contribute to skin reactions, pneumonitis and diarrhea, which makes attribution harder (Brower et al., 2024). For this reason, surveillance also needs to consider the immune events of pembrolizumab. The same review recalls, for example, that fatigue may come from adrenal insufficiency, hypophysitis or hypothyroidism, and not only from the conjugate (Brower et al., 2024). The post about interprofessional clinical reasoning shows how oncology, nursing, pharmacy and endocrinology can share this surveillance.

Regulatory status: FDA and EMA

FDA

According to Drugs@FDA, Padcev, BLA 761137, was approved in the United States on December 18, 2019, with accelerated approval (Drugs@FDA, BLA 761137). On April 3, 2023, supplement 18 brought the accelerated approval of the combination with pembrolizumab for those who could not receive cisplatin (Drugs@FDA, BLA 761137). On December 15, 2023, supplements 24 and 25 were approved, one classified as a new patient population and the other linked to the previous accelerated approval (Drugs@FDA, BLA 761137). Since then, the label indicates the combination for all adults with locally advanced or metastatic urothelial carcinoma (US Padcev label, 07/2026). On November 21, 2025, the FDA approved the use of the combination before and after cystectomy in muscle-invasive bladder cancer, for those who cannot receive cisplatin (FDA letter of 11/21/2025). On July 10, 2026, supplement 37 extended this use to adults with muscle-invasive bladder cancer, with pembrolizumab or pembrolizumab with berahialuronidase alfa (FDA letter of 07/10/2026). The label consulted is the 07/2026 revision (US Padcev label, 07/2026).

Keytruda, BLA 125514, was approved in the United States on September 4, 2014 (Drugs@FDA, BLA 125514). The record has many supplements, and the most recent listed in the consultation is from October 16, 2026 (Drugs@FDA, BLA 125514).

EMA

In the European Union, Padcev received a positive opinion on February 24, 2022 and authorization on April 13, 2022 (EMA, Padcev page). The EMA page lists three uses: monotherapy after platinum and after a PD-1 or PD-L1 inhibitor, first line with pembrolizumab in unresectable or metastatic disease, and use before and after surgery with pembrolizumab in muscle-invasive cancer, when cisplatin is not suitable (EMA, Padcev page). The page was updated on July 22, 2026 (EMA, Padcev page).

Keytruda received a positive opinion on May 20, 2015 and authorization on July 17, 2015, and the page lists urothelial carcinoma among the indications (EMA, Keytruda page). The page was updated on September 3, 2026 (EMA, Keytruda page).

The table summarizes the dates.

Drug	Agency	Event	Date	Source
Padcev	FDA	Initial accelerated approval, BLA 761137	12/18/2019	(Drugs@FDA, BLA 761137)
Padcev	FDA	Combination with pembrolizumab for all adults with advanced disease, supplement 24	12/15/2023	(Drugs@FDA, BLA 761137)
Padcev	FDA	Muscle-invasive cancer, cisplatin-ineligible, supplement 32	11/21/2025	(FDA letter of 11/21/2025)
Padcev	FDA	Muscle-invasive cancer, all adults, supplement 37	07/10/2026	(FDA letter of 07/10/2026)
Padcev	EMA	Authorization in the European Union	04/13/2022	(EMA, Padcev page)
Keytruda	FDA	Initial approval, BLA 125514	09/04/2014	(Drugs@FDA, BLA 125514)
Keytruda	EMA	Authorization in the European Union	07/17/2015	(EMA, Keytruda page)

What the studies showed

EV-301, the second-line proof

EV-301 randomized 608 patients already treated with platinum and a checkpoint inhibitor to enfortumab vedotin or investigator's choice chemotherapy (Powles et al., 2021). Median overall survival was 12.88 months with enfortumab vedotin and 8.97 months with chemotherapy (Powles et al., 2021). Estimated 12-month survival was 51.5 percent versus 39.2 percent (Powles et al., 2021).

EV-103, cohort K

The K cohort of the EV-103 study randomized 151 patients with no prior treatment and ineligible for cisplatin to the combination or to enfortumab vedotin alone (O'Donnell et al., 2023). The confirmed objective response with the combination was 64.5 percent, and 65.4 percent of those who responded maintained the response at 12 months (O'Donnell et al., 2023). These data opened the way for the phase 3 study.

EV-302, the first-line change

EV-302 was an open-label study that randomized 886 patients with no prior treatment: 442 to the combination and 444 to gemcitabine with cisplatin or carboplatin (US label of Padcev, 07/2026). Gemcitabine was 1000 mg/m² on days 1 and 8, with cisplatin 70 mg/m² or carboplatin with AUC of 4.5 to 5, for up to six cycles (US label of Padcev, 07/2026). The study excluded active central nervous system metastases, grade 2 or higher neuropathy and glycated hemoglobin of 8 percent or more, or 7 percent or more with symptoms of diabetes (US label of Padcev, 07/2026).

Median overall survival was 31.5 months with the combination and 16.1 months with chemotherapy, with a hazard ratio of 0.47 (US label of Padcev, 07/2026). Median progression-free survival was 12.5 versus 6.3 months, with a hazard ratio of 0.45 (US label of Padcev, 07/2026). The confirmed objective response was 67.7 percent versus 44.4 percent, and the complete response was 29.1 percent versus 12.5 percent (US label of Padcev, 07/2026). The label says the results were consistent across all stratified subgroups (US label of Padcev, 07/2026).

Other first-line options

In CheckMate 901, with 608 patients eligible for cisplatin, nivolumab with gemcitabine and cisplatin brought median overall survival to 21.7 months, versus 18.9 months with chemotherapy, with a hazard ratio of 0.78 (van der Heijden et al., 2023). In JAVELIN Bladder 100, with 700 patients without progression after platinum chemotherapy, maintenance with avelumab brought median overall survival to 23.8 months, versus 15.0 months, with a hazard ratio of 0.76 (Powles et al., 2023). A meta-analysis of 11 studies with 2128 patients concluded that the combination had the highest response rates in the first line (Yajima et al., 2025).

The table summarizes the main studies.

Study	Population	Participants	Main result	Source
EV-301	Advanced disease already treated	608	Overall survival of 12.88 versus 8.97 months	(Powles et al., 2021)
EV-103, cohort K	First line, ineligible for cisplatin	151	Objective response of 64.5 percent with the combination	(O'Donnell et al., 2023)
EV-302	First line, with or without eligibility for cisplatin	886	Overall survival of 31.5 versus 16.1 months, hazard ratio of 0.47	(US label of Padcev, 07/2026)
CheckMate 901	First line, eligible for cisplatin	608	Overall survival of 21.7 versus 18.9 months	(van der Heijden et al., 2023)
JAVELIN Bladder 100	Maintenance after platinum	700	Overall survival of 23.8 versus 15.0 months	(Powles et al., 2023)

How to read these numbers

Comparing medians between different studies is dangerous, because the populations, the entry criteria and the follow-up time change. EV-302 compared the combination with chemotherapy in the same study, and that is why it weighs so much. The study was open-label, and those with poorly controlled diabetes or moderate neuropathy did not enter (US label of Padcev, 07/2026). For such patients, the evidence is indirect, and the decision should be shared. A series of six patients with locally advanced or oligometastatic disease showed a complete response after a median of six cycles, followed by cystectomy with pathological complete response in all (Jang et al., 2025). It is a small series and does not change management, but it shows why some teams already discuss cure in selected cases (Jang et al., 2025).

From selection to follow-up

Before starting

• Confirm the diagnosis, the extent of the disease and the functional status.
• Measure glycated hemoglobin and blood glucose, remembering that EV-302 excluded glycated hemoglobin of 8 percent or more.
• Grade baseline neuropathy and record the foot examination.
• Examine the skin and ask about previous severe skin reactions.
• Ask about eye symptoms and advise on artificial tears.
• Order baseline thyroid, liver and kidney tests for later comparison.

Dose

The US label indicates enfortumab vedotin 1.25 mg/kg, up to 125 mg in those weighing 100 kg or more, intravenously over 30 minutes on days 1 and 8 of 21-day cycles, until progression or unacceptable toxicity (US Padcev label, 07/2026). On the same day, enfortumab vedotin comes before pembrolizumab (US Padcev label, 07/2026). In EV-302, pembrolizumab was 200 mg intravenously on day 1 of each 21-day cycle, for up to two years (US Padcev label, 07/2026). The label does not list contraindications (US Padcev label, 07/2026).

Skin

With the combination in advanced disease, 70 percent of 564 patients had a skin reaction, and 17 percent had a grade 3 or 4 reaction (US Padcev label, 07/2026). There was one death from bullous dermatitis, 0.2 percent (US Padcev label, 07/2026). The median time to onset of severe reactions was 1.7 months, and 6 percent discontinued enfortumab vedotin because of the skin (US Padcev label, 07/2026). With suspected Stevens-Johnson syndrome or toxic epidermal necrolysis, the label says to hold the drug at once and consider specialist evaluation; if confirmed, the hold is permanent (US Padcev label, 07/2026). Grade 4 or recurrent grade 3 reactions also lead to a permanent hold (US Padcev label, 07/2026).

In the management experience described in a review, mild reactions were treated with topical corticosteroid and oral antihistamine, and grade 3 reactions led to interruption or delay of the dose until improvement (Lacouture et al., 2022). A Japanese cohort used routine dexamethasone as premedication, but it had no comparison group, and the authors say it is not possible to conclude about the effect on efficacy or toxicity (Hara et al., 2026). The main studies did not allow systemic corticosteroid for prevention (Hara et al., 2026).

Blood glucose

The label describes hyperglycemia and diabetic ketoacidosis, including fatal cases, in patients with and without diabetes (US Padcev label, 07/2026). The median time to onset was half a month, and the risk rose with higher body mass index and higher baseline glycated hemoglobin (US Padcev label, 07/2026). If blood glucose goes above 250 mg/dL, enfortumab vedotin should be held until it returns to 250 mg/dL or less (US Padcev label, 07/2026). A review on management advises repeating non-fasting blood glucose before each dose (Brower et al., 2024). For the man in the scene, with glycated hemoglobin of 7.4 percent, the plan includes home capillary blood glucose in the first weeks and direct contact with the team if the values rise.

Nerves

With the combination in advanced disease, peripheral neuropathy appeared in 67 percent, and the median time to onset of grade 2 or higher neuropathy was six months (US Padcev label, 07/2026). A management review lists, for the combination, rash in 68 percent, peripheral neuropathy in 67 percent and fatigue in 51 percent (Brower et al., 2024). For grade 3 or 4 events, the same review cites rash in 15 percent, neuropathy in 8 percent and fatigue in 6 percent (Brower et al., 2024). For the man in the scene, the grade 1 numbness needs to be recorded before the first cycle so that worsening is recognized.

Lungs, eyes and other risks

With the combination in advanced disease, 10 percent had pneumonitis or interstitial lung disease, 4 percent grade 3 or 4, with two deaths, 0.4 percent (US Padcev label, 07/2026). The frequency was higher with the combination than with enfortumab vedotin alone (US Padcev label, 07/2026). New cough or shortness of breath calls for prompt evaluation. The label also describes ocular surface disease in 40 percent of patients on monotherapy, with dry eye in 30 percent, and suggests considering artificial tears (US Padcev label, 07/2026). There is a risk of tissue damage if the infusion extravasates, and the label calls for contraception for two months after the last dose in women and for four months in men with a partner who could become pregnant (US Padcev label, 07/2026).

What pharmacovigilance adds

An analysis of 892 reports in VigiBase and 1698 in FAERS with the combination found, in FAERS, rash, peripheral neuropathy, diarrhea, itching and fatigue among the most reported events, along with interstitial lung disease (Li et al., 2026). In VigiBase, Stevens-Johnson syndrome and hyperglycemia appeared among the ten most reported events (Li et al., 2026). The authors say the pattern agrees with the label and that spontaneous reports do not prove cause (Li et al., 2026).

Follow-up

Follow-up includes skin, blood glucose and nerve symptoms at every visit, periodic thyroid and liver function, and imaging to assess response. The post on diagnostic pause helps you stop before attributing every new symptom to treatment, because infection, progression and other diseases remain possible.

How NEXO helps train this reasoning

In NEXO, the case of the day is fictional, with a real clinical presentation and up to six progressive clues, and you propose the diagnosis by looking for the ICD-10 code. Urothelial cancer with diabetes is a good exercise because a blood glucose reading, a blister on the skin or a new cough changes management. The post on case-based learning explains why this format fixes knowledge.

Three exercises with cases

Change the blood glucose. Say what to do if, on day 8 of the first cycle, blood glucose came in at 310 mg/dL, without ketosis.

Change the skin. Say what to do if blisters and mouth lesions appeared in the third week.

Change the nerves. Say what changes if the numbness rose to the ankles and he began to stumble.

The post on simulation of a consultation helps train the conversation with the family about expectations and warning signs.

The limits on use of the game are described on the NEXO economy page. If you research the teaching of clinical reasoning, the page for researchers explains how to get in touch. Professionals who write or review cases find information under curation and under creators, and institutions can learn about the proposal on the for partnerships page.

Frequently asked questions

Does the combination replace platinum chemotherapy?

In EV-302, the combination had longer overall survival than platinum chemotherapy in the first line (US label for Padcev, 07/2026). The choice remains individual.

What is the dose?

Enfortumab vedotin 1.25 mg/kg, up to 125 mg, on days 1 and 8 of 21-day cycles, before pembrolizumab (US label for Padcev, 07/2026).

Can people with diabetes use it?

Yes, with monitoring. EV-302 excluded glycated hemoglobin of 8 percent or more, and the label says to hold if blood glucose goes above 250 mg/dL (US label for Padcev, 07/2026).

Is nectin-4 testing required?

The US label does not require nectin-4 testing among the conditions of use (US label for Padcev, 07/2026). One study showed loss of expression in metastases and proposes testing with biopsy (Klümper et al., 2023).

What is the most urgent warning sign?

Blisters, peeling or lesions in the mouth and eyes, which may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis (US label for Padcev, 07/2026).

Final checklist

• I defined eligibility for cisplatin.
• I measured glycated hemoglobin before starting.
• I graded baseline neuropathy.
• I examined skin and eyes.
• I checked the dose and the order of infusions.
• I scheduled blood glucose before each dose.
• I gave guidance on blisters, cough and numbness.
• I ordered baseline thyroid, liver and kidney tests.

Want to practice reasoning with progressive clues? Play the case of the day.

References

1. Astellas Pharma US. PADCEV® (enfortumab vedotin-ejfv) for injection, for intravenous use. Prescribing Information. Revised 07/2026. Accessed 24/10/2026. Official source.
2. Ballestín P, López de Sá A, Díaz-Tejeiro C, et al. Understanding the Toxicity Profile of Approved ADCs. Pharmaceutics. 2025. PMID 40006625.
3. Brower B, McCoy A, Ahmad H, et al. Managing potential adverse events during treatment with enfortumab vedotin + pembrolizumab in patients with advanced urothelial cancer. Front Oncol. 2024. PMID 38711854.
4. European Medicines Agency. Keytruda | European Medicines Agency (EMA). Accessed on 24/10/2026. Official source.
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7. Jang A, Tripathi N, Lanka SM, et al. Advanced urothelial carcinoma treated with enfortumab vedotin and pembrolizumab: a path to cure? Oncologist. 2025. PMID 40828887.
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14. Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021. PMID 33577729.
15. U.S. Food and Drug Administration. BLA 761137/S-032 SUPPLEMENT APPROVAL. Letter of 21/11/2025. Accessed on 24/10/2026. Official source.
16. U.S. Food and Drug Administration. BLA 761137/S-037 SUPPLEMENT APPROVAL. Letter of 10/07/2026. Accessed on 24/10/2026. Official source.
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