Abstract 319P
Background
Enfortumab vedotin (EV), as monotherapy (mono) or combined with pembrolizumab (P), has shown overall survival (OS) benefit in metastatic urothelial carcinoma (mUC) patients (pts), regardless of prior systemic therapy. Despite positive data from pivotal trials, the real-life experience with EV in Asian pts, particularly treatment-related adverse events (TRAEs), remains uncertain. This is the first report on the preliminary efficacy and tolerability of EV±P in real-world mUC pts in Hong Kong (HK).
Methods
We retrospectively collected demographics, treatment response, TRAEs, and other clinical data on mUC pts treated with EV±P in public/private hospitals in HK from June 2023–May 2024. TRAEs were reported per the CTCAE version 5.0 criteria. Objective response rates (ORRs) were assessed per the RECIST version 1.1. OS was estimated using the Kaplan-Meier method.
Results
Totally 18 pts had a median age of 74 years (range: 46–90), with 83.3% and 16.7% having ECOG 0–1 and 2–3. The bladder and the upper urinary tract were primary tumor sites in each 50% of pts. Most pts (77.8%) had ≥1 visceral metastasis. Most pts (9/12) on EV+P had no prior treatments. In pts on EV mono (n=6), 66.7% and 33.3% had 2 and ≥3 prior lines of treatments. Pts on EV+P and EV mono had median EV cycles of 4.5 (1–10) and 3 (1–8) and ORRs of 75% and 33.3%. Two (16.7%) pts on EV+P had complete response. TRAEs led to 38.9% of EV interruptions, 33.3% of dose reductions, and 5.56% of discontinuations. Any-grade TRAEs occurred in 88.8% of pts (pruritis: 77.8%; peripheral neuropathy: 66.7%; rash: 50%). Three pts (16.7%; EV+P: 2; EV mono: 1) had Grade ≥3 rash. The 6-month OS rate was 70% (mean follow-up, 2.11 months).
Conclusions
Our preliminary real-world data showed promising antitumor activities of EV±P in Asian mUC pts. EV+P appeared to yield a higher ORR vs. EV mono. Skin toxicities (pruritis and rash) were major concerns in our cohort, highlighting a unique EV tolerability profile in Asian pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.