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After 2.5 years of follow-up, PADCEVTM + pembrolizumab has confirmed the unprecedented results from the EV-302 study

Overall survival in EV-302

PADCEV + pembrolizumab nearly doubled mOS vs platinum-based chemotherapy1,2

OS analysis

PADCEV + pembrolizumab significantly extended OS vs platinum-based chemotherapy1

Median follow-up time: 17.3 months (range: 0.3-37.2)1

EV-302 OS KM: 31.5 months with PADCEV + pembrolizumab vs 16.1 with chemo
EV-302 OS KM: 31.5 months with PADCEV + pembrolizumab vs 16.1 with chemo

PADCEV India Prescribing Information.1

Icon: EV-302 primary OS: 53% reduction in the risk of death vs chemo

53% reduced risk of death vs platinum-based chemotherapy1,3

(N=886; HR=0.47*; 95% CI: 0.38–0.58; p<0.00001†)

  • *Based on a stratified Cox proportional hazards model.1
  • †Based on stratified log-rank test. Two-sided p-value.1

The OS benefit of PADCEV + pembrolizumab was maintained with an additional year of follow-up2

Median follow-up time: 29.1 months (range: 28.5-29.9)2

Graphic: EV-302 long-term follow-up OS KM: 33.8 months with PADCEV + pembrolizumab vs 15.9 with chemo
Graphic: EV-302 long-term follow-up OS KM: 33.8 months with PADCEV + pembrolizumab vs 15.9 with chemo

Adapted from Powles 2025.2

*P-value is nominal and descriptive.2

Events/N were 203/442 for PADCEV + pembrolizumab and 297/444 for chemotherapy.2

Progression-free survival in EV-302

PADCEV + pembrolizumab nearly doubled mPFS vs platinum-based chemotherapy1,2

PFS analysis

PADCEV + pembrolizumab significantly extended PFS vs platinum-based chemotherapy1

Median follow-up time: 17.3 months (range: 0.3-37.2)1

Graphic: EV-302 PFS KM:12.5 months with PADCEV + pembrolizumab vs 6.3 months with chemo
Graphic: EV-302 PFS KM:12.5 months with PADCEV + pembrolizumab vs 6.3 months with chemo

PADCEV India Prescribing Information.1

Icon: EV-302 primary PFS: 55% reduction in the risk of progression vs chemo

55% reduced risk of progression or death vs platinum-based chemotherapy1,3

(N=886; HR=0.45*; 95% CI: 0.38–0.54; p<0.00001†)1,3

  • * Based on a stratified Cox proportional hazards model.1
  • †Based on stratified log-rank test. Two-sided p-value.1

The PFS benefit of PADCEV + pembrolizumab was maintained with an additional year of follow-up2

Median follow-up time: 29.1 months (range: 28.5-29.9)2

Graphic: EV-302 long-term follow-up PFS KM: 12.5 months with PADCEV + pembrolizumab vs 6.3 months with chemo
Graphic: EV-302 long-term follow-up PFS KM: 12.5 months with PADCEV + pembrolizumab vs 6.3 months with chemo

Adapted from Powles 2025.2

Events/N were 262/442 for PADCEV + pembrolizumab and 317/444 for platinum-based chemotherapy.2

*P-value is nominal and descriptive.2

Extended follow-up OS by subgroups

OS benefit was consistent for PADCEV + pembrolizumab across prespecified subgroups after 1 year of additional follow-up2*

Median follow-up time: 29.1 months (95% CI: 28.5-29.9)2

SubgroupPADCEV +
pembrolizumab
mOS, months (events/N)		Platinum-based
chemotherapy
mOS, months (events/N)		HR (95% CI) 
Overall33.8 (203/442)15.9 (297/444) 0.51 (0.43–0.61)
Age
<65 years39.3 (59/144)18.7 (87/135) 0.43 (0.31–0.61)
≥65 years27.1 (144/298)14.6 (210/309) 0.54 (0.44–0.67)
Race
White26.1 (158/308)15.1 (207/290) 0.52 (0.42–0.64)
Other36.3 (45/134)19.1 (90/154) 0.44 (0.30–0.63)
Region
North America25.7 (57/103)21.0 (54/85) 0.67 (0.45–1.00)
Europe25.6 (90/172)14.6 (140/197) 0.52 (0.40–0.69)
Rest of worldNR (56/167)15.5 (130/162) 0.39 (0.28–0.54)
Sex
Female25.4 (46/98)14.6 (70/108) 0.55 (0.37–0.81)
Male33.8 (157/344)16.4 (227/336) 0.50 (0.41–0.62)
ECOG PS
036.5 (77/223)18.7 (136/215) 0.39 (0.30–0.52)
1-222.8 (126/219)13.3 (160/227) 0.62 (0.49–0.79)
Primary disease site of origin
Upper tract36.5 (60/135)18.3 (63/104) 0.54 (0.37–0.78)
Lower tract32.9 (142/305)15.6 (233/339) 0.50 (0.41–0.62)
Liver metastases
Present19.1 (68/100)10.1 (82/99) 0.56 (0.40–0.78)
Absent39.3 (135/342)18.3 (215/345) 0.50 (0.40–0362)
PD-L1 expression
Low (CPS <10)31.2 (91/184)15.1 (136/185) 0.47 (0.36–0.62)
High (CPS ≥10)36.2 (111/254)17.1 (158/254) 0.55 (0.43–0.64)
Cisplatin eligibility
Eligible36.7 (101/244)18.7 (143/234) 0.54 (0.41–0.62)
Ineligible25.6 (102/198)12.7 (154/210) 0.50 (0.39–0.64)
Metastatic disease site
Visceral metastases25.7 (163/318)13.5 (235/318) 0.51 (0.41–0.62)
Lymph node onlyNR (34/103)24.4 (54/104) 0.51 (0.33–0.79)
Renal function
Normal39.3 (33/84)18.6 (61/95) 0.50 (.032–0.77)
Mild36.5 (69/165)18.4 (101/162) 0.50 (0.37–0.69)
Moderate/severe25.6 (101/193)13.3 (135/187) 0.53 (0.41–0.69)
     

Adapted from Powles 2025.2

  • *Subgroup analyses were exploratory in nature. This study was not powered to detect differences between treatments based on prespecified subgroups.2

Long-term follow-up survival response rates

Superior responses were maintained with PADCEV + pembrolizumab vs platinum-based chemotherapy after 1 year of additional follow-up2

Secondary outcome measures: Confirmed ORR and DOR per BICR2

Graphic: EV-302 Secondary outcome measures confirmed ORR and DOR per BICR
Graphic: EV-302 Secondary outcome measures 2x the rate of CR
Graphic: EV-302 Secondary outcome measures 3x the rate of mDOR

Graphic elaboration of Powles 2025.2

Responses with PADCEV + pembrolizumab were achieved as quickly as chemotherapy and were more durable than chemotherapy, regardless of cisplatin eligibility2,3

Probability of maintaining CR at 24 months was 74.3% with PADCEV+ pembrolizumab vs 43.2% with platinum-based chemotherapy2

Duration of cCR by BICR2

Graphic: EV-302 Duration of cCR by BICR KM curve. 74.3% with PADCEV + pembrolizumab vs 43.2% with chemo
Graphic: EV-302 Duration of cCR by BICR KM curve. 74.3% with PADCEV + pembrolizumab vs 43.2% with chemo

Adapted from Powles 2025.2

Among patients who achieved CR, the estimated 2-year OS was 95.4% for PADCEV + pembrolizumab vs 85.8% for chemotherapy (HR=0.37; 95% CI: 0.17–0.80)4

Study design

EV-302: A pivotal Phase III trial in 1L unresectable or metastatic UC1

EV-302: Study Design. See information in surrounding copy.
EV-302: Study Design. See information in surrounding copy.

Random assignment was stratified by cisplatin eligibility (eligible or ineligible), PD-L1 expression (high or low), and liver metastases (present or absent).1

Dual primary endpoints: OS and PFS by BICR per RECIST v1.11

  • Patients were enrolled in the EV-302 trial with no biomarker-based preselection, including Nectin-4 and PD-L13
  • Secondary endpoints included BICR-assessed ORR, DOR, time to pain progression, and safety profiles3

Key inclusion and exclusion criteria in the EV-302 trial

Key inclusion criteria3

  • Adult patients with radiologically measurable, histologically documented, unresectable locally advanced or metastatic UC including squamous differentiation or mixed cell types, with no biomarker-based preselection, including Nectin-4 and PD-L1

Key exclusion criteria3

  • Prior PD-1 or PD-L1 inhibitor or other systemic therapy (except neoadjuvant or adjuvant chemotherapy post-surgery with recurrence >12 months from therapy completion)
  • Uncontrolled diabetes
  • Ongoing Grade ≥2 sensory or motor neuropathy
  • Prior autoimmune disease requiring systemic treatment in the past 2 years
EV-302: Patient case study

Clinical case studies for 1L combination therapy

Explore hypothetical patient case studies for 1L PADCEV + pembrolizumab combination therapy.

Baseline patient characteristics

The EV-302 trial was designed to assess a range of patients with previously untreated unresectable or metastatic UC3

Baseline patient characteristicsPADCEV + pembrolizumab (n=442)Platinum-based chemotherapy (n=444)
Median age, years (range)69 (37–87)69 (22–91)
Age ≥75 yr, n (%)102 (23.1)108 (24.3)
Sex, n (%)
Male344 (77.8)336 (75.7)
Female98 (22.2)108 (24.3)
BMI, n (%)
<25 kg/m2206 (46.6)185 (41.7)
25 to <30 kg/m2144 (32.6)155 (34.9)
≤30 kg/m289 (20.1)101 (22.7)
Data missing3 (0.7)3 (0.7)
Race, n(%)
Asian99 (22.4)92 (20.7)
Black or African American3 (0.7)7 (1.6)
White308 (69.7)290 (65.3)
Other or multiple5 (1.1)8 (1.8)
Unknown or not reported27 (6.1)47 (10.6)
Geographic region, n (%)
North America103 (23.3)85 (19.1)
Europe172 (38.9)197 (44.4)
Rest of world167 (37.8)162 (36.5)
Cisplatin eligibility status, n (%)
Eligible240 (54.3)242 (54.5)
Ineligible202 (45.7)202 (45.5)
PD-L1 expression, n (%)
No.438439
High (CPS ≥10)254 (58.0)254 (57.9)
Low (CPS <10)184 (42.0)185 (42.1)
ECOG PS, n (%)
0223 (50.5)215 (48.4)
1204 (46.2)216 (48.6)
215 (3.4)11 (2.5)
Data missing02 (0.5)
Creatinine clearance, n (%)
≥60 mL/min249 (56.3)257 (57.9)
<60 mL/min193 (43.7)187 (42.1)
Disease status at randomisation, n (%)
Locally advanced21 (4.8)24 (5.4)
Metastatic421 (95.2)420 (94.6)
Primary site of origin of disease, n (%)
Upper tract135 (30.5)104 (23.4)
Lower tract305 (69.0)339 (76.4)
Unknown2 (0.5)1 (0.2)
Sites of metastasis, n (%)
Lymph node only103 (23.3)104 (23.4)
Visceral site318 (71.9)318 (71.6)
Bone81 (18.3)102 (23.0)
Liver100 (22.6)99 (22.3)
Lung170 (38.5)157 (35.4)
H score of Nectin-4 expression, n, (%)
No. of patients tested394406
Median (range)280 (0–300)270 (0–300)
No. of Bajorin risk factors, n (%)
0179 (40.5)183 (41.2)
1263 (59.5)259 (58.3)
Data missing02 (0.5)
Histologic type, n (%)
UC379 (85.7)373 (84.0)
UC, mixed types50 (11.3)53 (11.9)
Variant UC only4 (0.9)7 (1.6)
Unknown9 (2.0)11 (2.5)

Adapted from Powles 2024.3

1L – first-line; 2L – second-line; AUC – area under the curve; BICR – blinded independent central review; BMI – body mass index; CI – confidence interval; CPS – combined positive score; cCR – confirmed complete response; CR – complete response; DOR – duration of response; ECOG PS – Eastern Cooperative Oncology Group performance status; HR – hazard ratio; IV – intravenous; MoA – mechanism of action; mOS – median overall survival; mPFS – median progression-free survival; NE – not estimable; NR – not reached; ORR – objective response rate; OS – overall survival; PD – progressive disease; PD-1 – programmed death receptor-1; PD-L1 – programmed death-ligand 1; PFS – progression-free survival; RECIST – Response Evaluation Criteria in Solid Tumours; UC – urothelial cancer

References

  1. PADCEV India prescribing information.
  2. Powles TB, van der Heijden MS, Loriot Y, et al. Enfortumab vedotin plus pembrolizumab in untreated locally advanced or metastatic urothelial carcinoma: 2.5-year median follow-up of the phase III EV-302/KEYNOTE-A39 trial. Ann Oncol 2025;36(10):1212-19.
  3. Powles T, Valderrama BP, Gupta S, et al; EV-302 Trial Investigators. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024;390(10):875-88.
  4. Powles TB, van der Heijden MS, Loriot Y, et al. EV-302: updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). Poster presented at: ASCO Genitourinary Cancers Symposium 2025; 13-15 February 2025; San Francisco, CA, USA. Poster #664.

Safety outcomes


See safety results for 1L unresectable or metastatic UC

Patient Profiles

Review a variety of case studies for PADCEV patients

Resources and treatment support

Access resources to help navigate treatment with confidence

PADCEV, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. 

 

PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.

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