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Adverse events
Adapted from Powles 2024.2
TRAEs leading to death were asthenia, diarrhoea, immune-mediated lung disease, multiple organ dysfunction syndrome, and pneumonitis (n=1 each) for the PADCEV + pembrolizumab arm and febrile neutropenia, myocardial infarction, neutropenic sepsis, and sepsis (n=1 each) for the chemotherapy arm.4
TRAEs are those for which there is a reasonable possibility that they were caused by the trial treatment, as assessed by the investigator. This analysis included all the patients who had received any dose of the trial treatment.4
TRAEs included are those of any grade occurring in ≥20% of patients in either treatment arm or Grade ≥3 occurring in ≥5% of patients in either treatment arm from the safety analysis set.4
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.5,6
To address and manage patient anxiety about actively reporting AEs, it may help to follow this 4-step communication approach with every PADCEV patient:
Adverse events of special interest
Data for remaining AEs are from the pooled safety population from both the Phase II EV-103 and the Phase III EV-302 study (N=564).1
*Combination therapy trials (N=564): 70% any Grade, 17% Grade 3 or 4 Monotherapy (N=793): 57% any Grade, 18.3% Grade 3-41
†Monotherapy (N=793): 53% any Grade, 5% Grade 3-4, Combination therapy (N=564): 67% any Grade, 8% Grade 3-41
Dose modifications due to adverse events
The most common AEs (≥2%) leading to dose reduction were peripheral sensory neuropathy (9.9%), maculopapular rash (6.4%), fatigue (3.2%), diarrhoea (2.3%), and neutropenia (2.1%).1
1L – first-line; 2L – second-line; AE – adverse event; Gr – grade; ILD – interstitial lung disease; MoA – mechanism of action; TRAE – treatment-related adverse event; TTO – time to onset
References
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.
MAT-IN-PAD-2026-00051
