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  • / Outcomes in patients (pts) with advanced urothelial carcinoma (aUC) treated with enfortumab vedotin (EV) after switch maintenance avelumab (MAv) in the UNITE study.

Outcomes in patients (pts) with advanced urothelial carcinoma (aUC) treated with enfortumab vedotin (EV) after switch maintenance avelumab (MAv) in the UNITE study.

Abstract Video & Slides

Authors

Amanda Nizam

Amanda Nizam

Cleveland Clinic, Cleveland, OH

Amanda Nizam , Tanya Jindal , Cindy Y. Jiang , Omar Alhalabi , Dimitra Rafailia Bakaloudi , Rafee Talukder , Matthew P. Davidsohn , Charles B Nguyen , Eugene Oh , Amy K Taylor , Emily Lemke , Deepak Kilari , Christopher J. Hoimes , Hamid Emamekhoo , Shilpa Gupta , Joaquim Bellmunt , Petros Grivas , Matthew T Campbell , Ajjai Shivaram Alva , Vadim S Koshkin

Organizations

Cleveland Clinic, Cleveland, OH, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, The University of Texas MD Anderson Hematology/Oncology Fellowship, Houston, TX, Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, Baylor College of Medicine, Houston, TX, Albert Einstein College of Medicine, New York, NY, Rogel Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, University of Michigan School of Medicine, Ann Arbor, MI, University of Wisconsin Hospital and Clinics, Madison, WI, Medical College of Wisconsin, Milwaukee, WI, Department of Medicine, Division of Hematology and Oncology, The Medical College of Wisconsin, Milwaukee, WI, Duke Cancer Institute, Duke University, Durham, NC, University of Wisconsin Carbone Cancer Center, Madison, WI, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, Dana-Farber Cancer Institute, Boston, MA, Division of Hematology & Oncology, University of Washington & Fred Hutchinson Cancer Center, Seattle, WA, The University of Texas MD Anderson Cancer Center, Houston, TX, Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan, Ann Arbor, MI, Division of Hematology and Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA

Research Funding

No funding sources reported

Background: MAv is approved in pts with aUC without progression (PD) on 1L platinum-based therapy (PBT). As pts in the pivotal EV trials had not received MAv after PBT, data on outcomes with EV post-MAv are limited. We examined outcomes with EV post-MAv in the multicenter retrospective UNITE study. We hypothesized that outcomes would be similar to published EV data. Methods: Pts who received sequential PBT, MAv, then EV monotherapy were included. Investigator-assessed observed response rate (ORR) was assessed for evaluable pts with scans after ≥ 1 cycle EV using χ2 test and logistic regression. Progression-free and overall survival (PFS, OS) were measured from EV start and assessed using ΚΜ method and Cox proportional hazards model. Results: Among 633 pts at 16 US sites, 49 received PBT and MAv then EV. Median age 72; 63% men; 96% Caucasian; 82% ECOG PS 0/1, 71% lower tract tumor; 65% pure urothelial histology; 71% visceral or bone mets; 33% Bellmunt score (BS) 2-3. In terms of PBT, 67% had cisplatin-based (cis); 26% carboplatin-based (carbo); 6% both cis- and carbo-based therapy. Best response to PBT was CR/PR/SD for 12% / 59% / 29% pts, respectively. Median time from PBT start to EV start was 8.5 months (mo) (3.9-21.2). Median follow up from EV start was 8.5 mo (95%CI 6.7-15.0). ORR to EV was 54%; median PFS and OS were 7.0 mo (95%CI 5.8-13.3) and 13.3 mo (95%CI 10.8-NR). Median PFS2 measured from PBT start until PD after starting EV or death was 17.5 mo (95%CI 15.2-22.5). Median OS from PBT start was 22.5 mo (95%CI 18.6-NR); 29% of pts remained on EV at data cutoff; 43% received subsequent therapy (Tx) after EV with median time to next therapy 6.4 mo (1.8-15.9). Outcomes did not differ among subgroups, except for improved PFS and OS in pts with BS 0-1 vs BS 2-3 (Table). Conclusions: Pts with aUC treated with EV after MAv had outcomes consistent with data for EV in PBT- and checkpoint inhibitor-refractory aUC. These data support the use of EV as third-line Tx after progression on MAv but should be validated in larger cohorts.

SubgroupsORR to EVmPFS: mo (95%CI)mPFS: HR (95%CI)mOS: mo (95%CI)mOS: HR (95%CI)
Cis- vs Carbo-PBT
(n=33 vs 13)*		50% vs 62%;
OR 0.63, p=0.49		8.3 (6.0-14.3) vs 7.0 (5.3-NR), p=0.591.26 (0.55-2.87), p=0.5913.3 (10.8-NR) vs NR (7.6-NR), p=0.331.85 (0.52-6.54), p=0.34
CR/PR vs SD on PBT
(n=35 vs 14)		62% vs 33%;
OR 3.27, p=0.10		10.8 (6.0-NR) vs 5.9 (2.5-NR), p=0.180.60 (0.28-1.29), p=0.1914.3 (12.2-NR) vs 10.8 (10.1-NR), p=0.540.73 (0.28-1.96), p=0.54
Median time on MAv >3 mo vs ≤3 mo
(n=22 vs 27)		63% vs 45%;
OR 2.06, p=0.26		7.0 (5.3-NR) vs 8.3 (4.8-14.3), p=0.250.64 (0.30-1.37), p=0.2517.2 (12.7-NR) vs 12.2 (7.6-NR), p=0.050.36 (0.13-1.05), p=0.06
BS 2-3 vs 0-1 (n=16 vs 27)50% vs 62%;
OR 0.62, p=0.47		5.3 (3.7-NR) vs 12.7 (6.0-NR), p=0.032.34 (1.05-5.19), p=0.0410.1 (6.9-NR) vs 16.6 (12.7-NR), p=0.023.32 (1.11-9.88), p=0.03

*Excluded 3 pts with cis + carbo prior to MAv.

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Abstract Details

Meeting

2024 ASCO Genitourinary Cancers Symposium

Session Type

Rapid Oral Abstract Session

Session Title

Rapid Oral Abstract Session B: Urothelial Carcinoma

Track

Urothelial Carcinoma

Sub Track

Quality of Care/Quality Improvement and Real-World Evidence

Citation

J Clin Oncol 42, 2024 (suppl 4; abstr 537)

DOI

10.1200/JCO.2024.42.4_suppl.537

Abstract #

537

Abstract Disclosures

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