What question did this study set out to answer?

This study aimed to describe treatment emergent adverse events (TEAEs) and management strategies during enfortumab vedotin plus pembrolizumab therapy for metastatic urothelial carcinoma.

March 4, 2026

Description and management strategies of prespecified treatment emergent adverse events (TEAEs) amongst patients (pts) treated with 1L enfortumab vedotin (EV) + pembrolizumab (P) for la/mUC in a real-world setting.

Key Points

This study aimed to describe treatment emergent adverse events (TEAEs) and management strategies during enfortumab vedotin plus pembrolizumab therapy for metastatic urothelial carcinoma.
Conducted a chart review using the Cardinal Health OPEN oncology network in the US.
Included adult patients with late-stage metastatic urothelial carcinoma who started therapy after October 22, 2023.
Identified common grade 2 and grade 3 TEAEs along with management strategies implemented by physicians.
In a cohort of 225 patients, 41.8% discontinued enfortumab vedotin due to adverse events, disease progression, or other reasons.
First dose reductions due to TEAEs occurred in 40.4% of patients, while delays or interruptions were noted in 27.1%.
The most common G2 and G≥3 TEAEs included peripheral neuropathy, fatigue, and hyperglycemia.

Abstract

671 Background: Based on EV-302 study results, EV+P is considered the standard of care therapy for 1L la/mUC. In EV-302, the most common Grade (G) ≥3 TEAEs of special interest for EV in the EV+P arm were skin reactions, peripheral neuropathy, and hyperglycemia. This real-world study aimed to describe prespecified G2 and G≥3 TEAEs and management strategies in pts who experienced these TEAEs during EV+P treatment for 1L la/mUC. Methods: This chart review study used the Cardinal Health OPEN oncology network in the US. Eligible adult pts had la/mUC, initiated 1L EV+P on/after 22-Oct-2023, experienced ≥1 prespecified TEAE, and had ≥6 mo of follow-up data. Prespecified TEAEs were selected due to being common with EV+P treatment and included non-hematologic TEAEs with dose modification recommendations in the USPI. TEAE management strategies were abstracted by treating physicians. Pts may have experienced ≥1 prespecified TEAE and ≥1 management strategy may have been implemented per TEAE. Results: In this cohort of pts (N=225), all of whom had ≥1 prespecified G≥2 TEAE, baseline characteristics included median (Q1–Q3) age of 69 (63–74) y, 69% male, 69% White, and 80% ECOG PS 0–1. At data cutoff, 41.8% of pts receiving 1L EV+P (n=94/225) had discontinued EV treatment, while 58.2% (n=131/225) remained on therapy. The reasons for EV discontinuations (n=94) were AE(s)/toxicity (n=38; 40.4%), disease progression (n=32; 34.0%), pt choice (n=14; 14.9%), physician decision (n=5; 5.3%), and/or death (n=4; 4.3%). Among all pts, first EV dose reductions and first delays/interruptions due to any TEAE occurred in 91 (40.4%) and 61 (27.1%) pts, respectively, with a median (Q1–Q3) time from EV initiation to dose reduction or delay/interruption of 67 (26–123) and 59 (29–106) days, respectively. Table shows rates of prespecified TEAEs and associated first dose reductions and/or delays/interruptions by TEAE/grade. Conclusions: EV dose modifications were frequently used to manage TEAEs in this real-world cohort; further data on management will be presented. Prespecified TEAEs, n (%) G2 G≥3 First EV dose reduction (G2 a / G≥3 b ) First EV dose delay/interruption (G2 a / G≥3 b ) Fatigue - c 36 (16.0) - / 13 (36.1) - / 1 (2.8) Diarrhea - c 29 (12.9) - / 7 (24.1) - / 10 (34.5) Decreased appetite - c 24 (10.7) - / 7 (29.2) - / 1 (4.2) Peripheral neuropathy 58 (25.8) 7 (3.1) 30 (51.7) / 3 (27.3) 17 (29.3) / 5 (45.5) Rash 37 (16.4) 4 (1.8) 18 (48.6) / 2 (50.0) 10 (27.0) / 2 (50.0) Hyperglycemia 34 (15.1) 4 (1.8) 8 (22.9) / 1 (16.7) 7 (20.0) / 5 (83.3) Dry skin 30 (13.3) 6 (2.7) 2 (6.5) / 0 3 (9.7) / 0 Pruritus 13 (5.8) 6 (2.7) 1 (7.7) / 1 (14.3) 4 (30.8) / 2 (28.6) Pneumonitis 6 (2.7) 3 (1.3) 1 (16.7) / 1 (33.3) 1 (16.7) / 1 (33.3) a % based on pts with G2 prespecified TEAEs. b % based on pts with G≥3 prespecified TEAEs; c Only prespecified as G≥3 TEAE.

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