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Significantly improved outcomes with PADCEVTM monotherapy1

Overall survival in EV-301

PADCEV significantly improved OS vs chemotherapy1

OS1,2

Intention-to-treat analysis with a median follow-up time of 11.1 months (95% CI: 10.6–11.6)1

EV-301 KM curve:12.9 months OS with PADCEV vs 9 months with chemotherapy
Overall survival in EV-301

PADCEV India Prescribing Information.1

For patients previously treated with platinum chemotherapy and a PD-1/PD-L1 inhibitor, PADCEV as monotherapy delivered an mOS of 12.9 months.1

  • *One-sided p-value; predetermined efficacy boundary=0.00679 (adjusted by observed deaths of 301).1

More than half of patients (52%) treated with PADCEV were alive at 1 year vs 39% treated with investigator-choice chemotherapy2

Progression-free survival in EV-301

PADCEV significantly prolonged PFS vs chemotherapy1

PFS1,2

EV-301 KM curve: 5.6 months mPFS with PADCEV vs 3.6 months mPFS with chemotherapy
Progression-free survival in EV-301

PADCEV India Prescribing Information and Powles 2021.1,2

  • *One-sided p-value; predetermined efficacy boundary=0.02189 (adjusted by observed PFS1 events of 432).1

Objective response rate in EV-301

PADCEV significantly improved response rate vs chemotherapy1,2

PADCEV more than doubled ORR* vs chemotherapy1,2

ORR1,3

EV-301 response results: 41% ORR with PADCEV vs 18% ORR with chemotherapy
EV-301 response results: 41% ORR with PADCEV
EV-301 response results: 18% ORR with chemotherapy

PADCEV India Prescribing Information and Powles 2021.1,3

  • CR was 5% (n=14) with PADCEV vs 3% (n=8) with chemotherapy1-3
  • PR was 36% (n=103) with PADCEV vs 15% (n=45) with chemotherapy1-3
  • Median DOR was 7.4 months (95% CI: 5.6–9.5) vs 8.1 months (95% CI: 5.7–9.6) with chemotherapy1‡
  • Disease control was observed in 72% of patients with PADCEV (95% CI: 66.3–77.0) vs 53% of patients with chemotherapy
    (95% CI: 47.5–59.2)(p<0.001)2§
  • *ORR consisted of confirmed CR and PR per RECIST v1.1 as evaluated by investigator.1
  • †One-sided p-value; predetermined efficacy boundary=0.025 (adjusted by 100% information fraction).1
  • ‡Kaplan–Meier estimate of DOR, defined as the time from first response to date of progression or death due to any cause, was assessed by investigator.4
  • §Disease control was defined as the proportion of patients who had a best overall response of confirmed CR, confirmed PR, or stable disease (≥7 weeks).4

Study design

PADCEV was evaluated vs chemotherapy in the Phase III EV-301 trial powered for OS1,2

A pivotal Phase III global, multicentre, open-label, randomised study of PADCEV vs investigator-choice chemotherapy1,2

Study design: the EV-301 trial1,2

EV-301 graphic: Study Design
EV-301 graphic: Study Design
  • No biomarker testing was required for study entry2
  • 98% of patients with tumour tissue available for pathology had Nectin-4 expression (n=516/527)4

Key inclusion and exclusion criteria in the EV-301 trial

Key inclusion criteria2

  • Urothelial cancer
  • Prior treatment with a platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting
  • ECOG PS of 0 or 1

Key exclusion criteria2

  • Ongoing sensory or motor neuropathy Grade ≥2
  • Uncontrolled diabetes†
  • Active CNS metastases
  • *Docetaxel was administered at 75 mg/m2, paclitaxel was administered at 175 mg/m2, and vinflunine was administered at 320 mg/m2.1
  • †Uncontrolled diabetes was defined as HbA1c ≥8% or HbA1c ≥7% with associated diabetes symptoms.1
EV-301 icon: Clinical Studies in 2L+ Monotherapy

Clinical case studies for 2L+ monotherapy

Explore hypothetical patient case studies for 2L+ PADCEV monotherapy.

Baseline patient characteristics

The EV-301 trial was designed to assess PADCEV in a broad range of patients with LA/mUC1

Baseline characteristics were balanced between treatment arms2,4

Baseline Patient CharacteristicsPADCEV (n=301)Chemotherapy (n=307)
Median age, years (range)68 (34—85)68 (30—88)
Sex, n (%)
Male238 (79)232 (76)
Female63 (21)75 (24)
ECOG PS, n (%)
0120 (40)124 (40)
1181 (60)183 (60)
Renal function based on CrCl, n (%)
Moderate decrease: ≥30 mL/min and <60 mL/min136 (45)139 (45)
Severe decrease: ≥15 mL/min and <30 mL/min4 (1)5 (2)
Primary tumour location, n (%)
Upper tract*98 (33)107 (35)
Bladder/other203 (67)200 (65)
Metastasis site, n (%)
Visceral†234 (78)250 (82)
Liver93 (31)95 (31)
Lymph node only34 (11)28 (9)
Non-responder‡ to prior PD-1 or PD-L1 inhibitor, n (%)207 (69)215 (70)
Preexisting Grade 1 peripheral neuropathy, 
n (%)§55 (19)58 (20)

Adapted from Powles 2021 and DOF Astellas Pharma India Private Limited. REF-29824.2,4

  • *Upper tract included renal pelvis and ureter.4
  • †Patients had baseline tumour results at the locations of lung, liver, spleen, adrenal gland, kidney, heart, colon, bone, or prostate gland.4
  • ‡Non-responders were defined as patients who had stable disease or progressive disease as best overall response on prior PD-1/PD-L1 inhibitor therapy.2
  • §Percentage of patients with preexisting peripheral neuropathy were calculated based on the safety analysis set for both the PADCEV (n=296) and chemotherapy (n=291) arms.2,4
EV-301 icon: 80% patients has visceral metastases

of all patients
had visceral
metastases4

EV-301 icon: 76% of patients 2+ lines of prior therapy

of all patients
had 2 lines of
prior systemic
therapy4

EV-301 icon: 20% of patients aged ≥75 years

of all patients
were aged ≥75
years4

EV-301 icon: 18% of patients responded to prior PD-1 or PD-L1 inhibitor therapy

of all patients
had a response
to prior therapy
with PD-1 or PD-
L1 inhibitor4

Prior treatments:

  • 52% PD-1 inhibitor, 47% PD-L1 inhibitor, 1% both1
  • 63% cisplatin-based regimen, 26% carboplatin-based regimen, 11% both1

1L - first-line; 2L - second-line; CI - confidence interval; CNS - central nervous system; CR - complete response; CrCl - creatinine clearance; DCR - disease control rate; DOR - duration of response; ECOG PS - Eastern Cooperative Oncology Group performance status; HbA1c - haemoglobin A1c; HR - hazard ratio; IV - intravenous; LA - locally advanced; MoA - mechanism of action; mOS - median overall survival; mPFS - median progression-free survival; mUC - metastatic urothelial cancer; ORR - objective response rate; OS - overall survival; PD-1 - programmed death receptor-1; PD-L1 - programmed death-ligand 1; PFS - progression-free survival; PFS1 - progression-free survival on study treatment; PR - partial response; RECIST - Response Evaluation Criteria in Solid Tumours

References

  1. PADCEV India prescribing information.
  2. Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med 2021;384(12):1125-35.
  3. Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med 2021;384(12):1125-35 (supplementary appendix).
  4. Data on file. Astellas Pharma India Private Limited. EV-301 clinical study report 2021. REF-29824.

Safety outcomes
 

See safety results for 2L+ locally advanced or metastatic UC

Dosing and Administration

Review dosing information and guidance for PADCEV

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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