This website is intended for Healthcare Professionals in India only.
Ethan represents a typical patient from the EV-302 trial, where the median patient age was 69 years and nearly half of patients had an ECOG PS 1. The trial included patients with renal function above ≥30 mL/min.3,4
The safety of PADCEV + pembrolizumab was well established, with no new safety signals after 2.5 years of follow-up, including in patients with moderate or severe renal function.1,5
EV-302 ITT outcomes: Compared with chemotherapy, PADCEV + pembrolizumab reduced the risk of death by 53% (HR=0.47; 95% CI: 0.38–0.58; p<0.00001) and disease progression by 55% (HR=0.45; 95% CI: 0.38–0.54; p<0.00001).1,3
Even after 2.5 years of median follow-up, PADCEV + pembrolizumab maintained its well-established safety profile across different patient populations. Most AESIs were low grade and no patients with diabetes discontinued due to hyperglycaemia. No dose adjustment is necessary in patients with mild (>60–90 mL/min) or moderate/severe decrease (≤60 mL/min) renal function.1,2,5
*Exploratory analysis in older patients and patients with comorbidities.5
PADCEV + pembrolizumab improved OS (HR=0.47) and PFS (HR=0.45) vs chemotherapy in the ITT population, and the survival benefits were maintained in older patients.1,5
For patients aged ≥75 years, PADCEV + pembrolizumab maintained a consistent safety profile, with most AESIs being low grade. Older patients aged ≥75 years received a median of 10.0 cycles (range: 1–39) of treatment.5
*Exploratory analysis in older patients and patients with comorbidities.5
†Post-hoc subgroup analysis.6
EV-302 ITT outcomes: Compared with chemotherapy, PADCEV + pembrolizumab reduced the risk of death by 53% (HR=0.47; 95% CI: 0.38–0.58); p<0.00001) and disease progression by 55% (HR=0.45; 95% CI: 0.38–0.54; p<0.00001).1,3,6,7
Even in complex cases, the well-established safety of PADCEV + pembrolizumab was maintained, with no new safety signals after 2.5 years of follow-up.2,6,7
†Post-hoc subgroup analysis.6
EV-302 ITT outcomes: Compared with chemotherapy, PADCEV + pembrolizumab reduced the risk of death by 53% (HR=0.47; 95% CI: 0.38–0.58; p<0.00001) and disease progression by 55% (HR=0.45; 95% CI: 0.38–0.54; p<0.00001).1,3,6,7
PADCEV + pembrolizumab continued to demonstrate a consistent safety profile, with no new safety signals at 2.5 years of follow-up.2
†Post-hoc subgroup analysis.6
‡Exploratory analysis of responders of the EV-302 trial.8
AESI – adverse event of special interest; BCG – Bacillus Calmette-Guérin; BMI – body mass index; CI – confidence interval; CR – complete response; DOR – duration of response;ECOG PS – Eastern Cooperative Oncology Group performance status; GFR – glomerular filtration rate; HR – hazard ratio; ITT – intention-to-treat; mOS – median overall survival;mDOR – median duration of response; mPFS – median progression-free survival; NE – not estimable; ORR – objective response rate; OS – overall survival;PD-L1 – programmed death-ligand 1; PFS – progression-free survival; UC - urothelial cancer
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.
