REAL-WORLD FRONT-LINE USE OF ENFORTUMAB VEDOTIN - PEMBROLIZUMAB (EV+P) AFTER ADJUVANT NIVOLUMAB IN ADVANCED UROTHELIAL CANCER(AUC)
Author(s)
Melanie Mayer, PhD1, Aram Babcock, MBA, MS, RPh, PharmD, PhD2, Blanca Homet Moreno, MD, PhD2, Chethan Ramamurthy, MD2, Haojie Li, MD, PhD2, Ronac Mamtani, MD, MSCE3, Nicholas Seewald, PhD1;
1Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA, 2Merck & Co., Inc., Rahway, NJ, USA, 3University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA
1Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA, 2Merck & Co., Inc., Rahway, NJ, USA, 3University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA
OBJECTIVES: EV+P received accelerated FDA approval in April 2023 (EV-103) and full approval in December 2023 (EV-302) for the treatment of advanced urothelial cancer (aUC). By April 2024, EV+P had become the most common frontline (1L) regimen in the US, accounting for 50% of treatment starts. EV-302 excluded patients who had received prior immunotherapy in the perioperative setting. Treatment selection in this emerging post-immunotherapy population remains poorly understood. We examined real-world 1L treatment choices among aUC patients with prior exposure to adjuvant nivolumab.
METHODS: We analyzed the US Flatiron Health EHR-derived de-identified database. Included patients initiated guideline-concordant 1L systemic therapy for aUC on or after April 2023, who received prior nivolumab monotherapy within 6 months of curative-intent surgery, with follow-up through April 30, 2025. Descriptive statistics summarized baseline characteristics and 1L treatment regimens.
RESULTS: Among eligible aUC patients initiating 1L treatment (n=1447), 54 had received prior adjuvant nivolumab (mean age = 71 y, 79.6% male, 92.2% white, 19.1% ECOG performance status 2+, 66.7% cisplatin-ineligible, 70.4% bladder as primary site, and 82.4% from community practice). As of April 2025, approximately 48% (26/54) received EV+P, 24% (13/54) received EV, and 9% received platinum-based chemotherapy (5/54) as 1L therapy. Baseline clinical characteristics and time from last dose of adjuvant nivolumab to start of 1L therapy (median: 1.7 months for EV+P; 3.8 months for EV) were similar between the EV+P and EV monotherapy groups.
CONCLUSIONS: Among real-world patients with aUC who were previously treated with adjuvant nivolumab, EV+P accounted for nearly half 1L systemic therapies initiated after its FDA approval. EV monotherapy was also common, while platinum-based chemotherapy was used infrequently. Further research is needed to better understand 1L treatment decision-making and outcomes in the evolving landscape of perioperative immunotherapy.
METHODS: We analyzed the US Flatiron Health EHR-derived de-identified database. Included patients initiated guideline-concordant 1L systemic therapy for aUC on or after April 2023, who received prior nivolumab monotherapy within 6 months of curative-intent surgery, with follow-up through April 30, 2025. Descriptive statistics summarized baseline characteristics and 1L treatment regimens.
RESULTS: Among eligible aUC patients initiating 1L treatment (n=1447), 54 had received prior adjuvant nivolumab (mean age = 71 y, 79.6% male, 92.2% white, 19.1% ECOG performance status 2+, 66.7% cisplatin-ineligible, 70.4% bladder as primary site, and 82.4% from community practice). As of April 2025, approximately 48% (26/54) received EV+P, 24% (13/54) received EV, and 9% received platinum-based chemotherapy (5/54) as 1L therapy. Baseline clinical characteristics and time from last dose of adjuvant nivolumab to start of 1L therapy (median: 1.7 months for EV+P; 3.8 months for EV) were similar between the EV+P and EV monotherapy groups.
CONCLUSIONS: Among real-world patients with aUC who were previously treated with adjuvant nivolumab, EV+P accounted for nearly half 1L systemic therapies initiated after its FDA approval. EV monotherapy was also common, while platinum-based chemotherapy was used infrequently. Further research is needed to better understand 1L treatment decision-making and outcomes in the evolving landscape of perioperative immunotherapy.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
SA41
Topic
Study Approaches
Disease
SDC: Oncology, SDC: Urinary/Kidney Disorders