Treatment Patterns and Outcomes After Recurrence Following Adjuvant Nivolumab for Urothelial Carcinoma: An AGEHA Real-World Study.

OBJECTIVES: To describe post-recurrence treatment patterns and outcomes after adjuvant nivolumab for urothelial carcinoma in real-world practice.

METHODS: We retrospectively analyzed patients with urothelial carcinoma who underwent radical cystectomy or nephroureterectomy followed by adjuvant nivolumab in the multicenter AGEHA database. Among 141 patients, 40 developed recurrence, excluding non-muscle-invasive bladder recurrence. First-line post-recurrence treatment was categorized as enfortumab vedotin plus pembrolizumab (EVP), enfortumab vedotin (EV), non-EV regimens, or no systemic therapy. Overall survival (OS) was measured from recurrence and progression-free survival (PFS) from initiation of first-line post-recurrence therapy.

RESULTS: Of 141 patients treated with adjuvant nivolumab, 40 (28%) developed recurrence. First-line post-recurrence treatment was EVP in 10 patients, EV in 15, non-EV regimens in 12, and no systemic therapy in 3. Median time from surgery and nivolumab initiation to recurrence was 5.9 and 4.2 months, respectively. Median OS from recurrence was 27.1, 26.0, and 23.4 months in the EVP, EV, and non-EV groups, respectively, while median PFS from initiation of first-line post-recurrence therapy was 12.9, 7.6, and 8.7 months. Baseline characteristics differed across groups, particularly in recurrence timing and metastatic sites, and EV-based therapy was frequently selected after recurrence.

CONCLUSIONS: Recurrence after adjuvant nivolumab occurred in 28% of patients in real-world practice. Post-recurrence management was heterogeneous, and EV-based therapy was frequently used in this setting. These findings provide hypothesis-generating real-world evidence on treatment sequencing after adjuvant nivolumab and require validation in larger cohorts with longer follow-up.