PADCEVTM monotherapy safety profile in EV-301

Comparable safety profile in a pretreated population2

The majority of AEs reported with PADCEV were mild or moderate2

AEs reported in ≥20% (any grade) or ≥5% (Grade ≥3) of patients*2

AEsPADCEV
(n=296)
Chemotherapy
(n=291)
Any gradeGrade ≥3Any gradeGrade ≥3
Number of patients (%)Number of patients (%)
Any AE278 (93.9)152 (51.4)267 (91.8)145 (49.8)
Alopecia134 (45.3)0106 (36.4)0
Peripheral sensory neuropathy†100 (33.8)9 (3.0)62 (21.3)6 (2.1)
Pruritis95 (32.1)4 (1.4)13 (4.5)0
Fatigue92 (31.1)19 (6.4)66 (22.7)13 (4.5)
Decreased appetite91 (30.7)9 (3.0)68 (23.4)5 (1.7)
Diarrhoea72 (24.3)10 (3.4)48 (16.5)5 (1.7)
Dysgeusia72 (24.3)021 (7.2)0
Nausea67 (22.6)3 (1.0)63 (21.6)4 (1.4)
Maculopapular rash48 (16.2)22 (7.4)5 (1.7)0
Anaemia34 (11.5)8 (2.7)59 (20.3)22 (7.6)
Decreased neutrophil count30 (10.1)18 (6.1)49 (16.8)39 (13.4)
Neutropenia20 (6.8)14 (4.7)24 (8.2)18 (6.2)
Decreased white-cell count16 (5.4)4 (1.4)31 (10.7)20 (6.9)
Febrile neutropenia2 (0.7)2 (0.7)16 (5.5)16 (5.5)

Adapted from Powles 2021.2

*The safety population included all patients who received any amount of trial drug. Included are TRAEs that occurred in at least 20% of patients in either treatment group or TRAEs of Grade 3 or higher that occurred in at least 5% of patients in either treatment group. TRAEs are those for which there is a reasonable possibility that they were caused by the trial treatment, as assessed by the investigator. If data regarding the relationship to treatment were missing, the event was considered to be related to treatment.2

†A total of 113 patients (55 in the PADCEV group and 58 in the chemotherapy group) had preexisting peripheral neuropathy.2

Discontinuation rates due to drug-related TEAEs were similar for PADCEV and chemotherapy (14% vs 11%, respectively)2

Patient engagement and education

Optimising patient care: A 4-phase approach to proactively manage TRAEs in patients receiving PADCEV

Proactively monitoring for potential AEs is an important part of effective dosing management with PADCEV. Encouraging open dialogue helps support continuity of care and appropriate dose modifications when needed.3,4

To address and manage patient anxiety about actively reporting AEs, it may help to follow this 4-step communication approach with every PADCEV patient:

EV-301 Engage

Engage

Engage and educate patients to set expectations and agree on a reporting plan for AEs3

EV-301 Monitor

Monitor

During treatment, monitor for AEs at every visit, including clinical assessment and appropriate screening for key TRAEs3,4

EV-301 Act Early

Act Early

If an AE develops, act early, modify dose to manage AEs, and help support treatment continuity3

EV-301 Reassess

Reassess

After intervention, reassess AE severity and, if appropriate, resume PADCEV treatment3

1L - first-line; 2L - second-line; AE - adverse event; AR - adverse reactions; MoA - mechanism of action; TEAE - treatment-emergent adverse event; TRAE - treatment-related adverse event

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. Brower B, McCoy A, Ahmad H, et al. Managing potential adverse events duringtreatment with enfortumab vedotin + pembrolizumab in patients with advanced urothelial cancer. Front Oncol 2024;14:1326715.
  4. Pace A, Brower B, Conway D, et al. Enfortumab vedotin: nursing perspectives on the management of adverse events in patients with locally advanced or metastatic urothelial carcinoma Clin J Oncol Nurs 2021;25(2):E1-9.

Efficacy outcomes


Review efficacy outcomes in 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.

Adverse Event Reporting

Adverse Events (AE) should be reported. Kindly report an adverse event/side effect related to an Astellas product on
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