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2019 ASCO Annual Meeting!

Session: Genitourinary (Nonprostate) Cancer

Type: Oral Abstract Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Arie Crown Theater

EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors.

Bladder Cancer

Genitourinary (Nonprostate) Cancer

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr LBA4505)

Author(s): Daniel Peter Petrylak, Arjun Vasant Balar, Peter H. O'Donnell, Bradley Alexander McGregor, Elisabeth I. Heath, Evan Y. Yu, Matt D. Galsky, Noah M. Hahn, Elaina M Gartner, Juan Pinelli, Amal Melhem-Bertrandt, Jonathan E. Rosenberg; Yale School of Medicine, New Haven, CT; Perlmutter Cancer Center at NYU Langone Health, New York, NY; University of Chicago Comprehensive Cancer Center, Chicago, IL; Dana-Farber Cancer Institute, Boston, MA; Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI; University of Washington, Seattle, WA; Department of Medicine, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY; Johns Hopkins University School of Medicine, Baltimore, MD; Seattle Genetics, Bothell, WA; Seattle Genetics, Inc., Bothell, WA; Astellas Pharma US, Inc, Northbrook, IL; Memorial Sloan Kettering Cancer Center, New York, NY

Abstract Disclosures


Background: Locally advanced or metastatic urothelial cancer (la/mUC) remains a lethal disease with limited treatment options for patients (pts) who progress on or after platinum and/or checkpoint inhibitor (CPI). Enfortumab vedotin (EV) is an antibody-drug conjugate targeting Nectin-4, which is highly expressed in UC. EV-201 is a pivotal, single-arm, two-cohort study of EV in la/mUC patients with prior CPI and platinum-containing chemotherapy (Cohort 1) or a CPI and no prior chemotherapy (Cohort 2). Here, we present preliminary data from Cohort 1. Methods: Pts in this open-label, multicenter study received 1.25 mg/kg EV on Days 1, 8, and 15 of each 28-day cycle. The primary endpoint was confirmed ORR per RECIST 1.1 by blinded independent central review. Secondary endpoints are duration of response, PFS, OS, safety/tolerability. Results: Between Oct 2017 and Jul 2018, EV-201 enrolled 128 pts in Cohort 1 (la/mUC pts previously treated with platinum and a CPI), 125 of whom were treated with EV (70% male; median age 69 y [range 40–84 y]; 34% upper tract; a median of 2 prior systemic therapies). As of 03 Jan 2019, the confirmed ORR was 42% (95% CI: 33.6%–51.6%), with 9% CR. The ORR in CPI non-responders was 38% (95% CI: 27.3%–49.2%), and 36% (95% CI: 22.9%–50.8%) in pts with liver metastases (LM). Most common treatment-related AEs, as determined by investigators, included fatigue (50%), alopecia (48%), and decreased appetite (41%). Treatment-related AEs of interest include any rash (48% all grade, 11% ≥ G3) and any peripheral neuropathy (50% all grade, 3% ≥ G3). One death was reported as treatment related by the investigator (interstitial lung disease), but was confounded by a suspected pulmonary infection. Conclusions: Preliminary results from this EV pivotal study demonstrated a clinically meaningful ORR, consistent with the phase 1 trial, in la/mUC pts with prior platinum and CPI, including LM pts, where there is a high unmet need. EV was well tolerated with a manageable safety profile in these pts. Updated data, including duration of response, PFS, and OS will be presented. Clinical trial information: NCT03219333

Other Abstracts in this Sub-Category:


1. CALGB 90601 (Alliance): Randomized, double-blind, placebo-controlled phase III trial comparing gemcitabine and cisplatin with bevacizumab or placebo in patients with metastatic urothelial carcinoma.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4503 First Author: Jonathan E. Rosenberg
Category: Genitourinary (Nonprostate) Cancer - Bladder Cancer


2. Randomized double-blind phase II study of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients (pts) with metastatic urothelial cancer (mUC): HCRN GU14-182.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4504 First Author: Matt D. Galsky
Category: Genitourinary (Nonprostate) Cancer - Bladder Cancer


3. SWOG S1314: A randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4506 First Author: Thomas W. Flaig
Category: Genitourinary (Nonprostate) Cancer - Bladder Cancer