Best of ASCO - 2014 Annual Meeting



Attend this session at the
2019 ASCO Annual Meeting!

Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)

Type: Poster Session

Time: Saturday June 1, 8:00 AM to 11:00 AM

Location: Hall A

TROPHY-U-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy.

Immunoconjugates (non-IO)

Developmental Therapeutics and Tumor Biology (Nonimmuno)

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #141b)

J Clin Oncol 37, 2019 (suppl; abstr TPS3153)

Author(s): Scott T. Tagawa, Daniel Peter Petrylak, Petros Grivas, Neeraj Agarwal, Cora N. Sternberg, Chris Hernandez, Peggy Siemon-Hryczyk, Trishna Goswami, Yohann Loriot; Sandra and Edward Meyer Cancer Center, New York, NY; Yale School of Medicine, New Haven, CT; University of Washington, School of Medicine, Seattle, WA; University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Weil Cornell Medicine, New York, NY; Immunomedics, Inc., Morris Plains, NJ; Institut de Cancérologie Gustave Roussy, Villejuif, France

Abstract Disclosures


Background: Patients (pts) with advanced urothelial cancer (UC) who progress after checkpoint inhibitor (CPI) therapy (following failure of or ineligibility for platinum-based chemotherapy) have limited options. Trop-2 is an epithelial cell surface antigen overexpressed in UC (Avellini. Oncotarget 2017). Sacituzumab govitecan (SG) is an antibody-drug conjugate that targets Trop-2 and delivers the active metabolite SN38 of the topoisomerase I inhibitor irinotecan to tumor cells (Starodub. Clin Cancer Res 2015). In a phase 1/2 trial, pts with advanced cancers received SG on days 1 and 8 of a 21-day cycle. In the UC cohort, 45 evaluable pts received SG 10 mg/kg with a median of 2 (range 1–6) prior therapies. Objective response rate (ORR) was 31%; median duration of response was 12.9 mo. Grade ≥3 adverse events in ≥5% of pts were neutropenia/neutrophil count decreased (38%), anemia (13%), hypophosphatemia (11%), diarrhea (9%), fatigue (9%), and febrile neutropenia (7%). Median progression-free survival (PFS) was 7.3 mo and overall survival (OS) 16.3 mo (Tagawa 2019 ASCO Genitourinary Cancers Symposium). These results warrant further investigation in a dedicated phase 2 trial. Methods: TROPHY-U-01 (NCT03547973) is a single-arm, global phase 2 trial evaluating the antitumor activity of SG (10 mg/kg on days 1 and 8 of a 21-day cycle) in 140 pts with advanced UC and measurable disease. Patients are also required to have an Eastern Cooperative Oncology Group Performance Status score of 0 or 1 and creatinine clearance ≥30 mL/min. The pivotal cohort (Cohort 1: progression after both platinum chemotherapy and CPI) will enroll 100 evaluable pts in a Simon 2-stage design with > 90% power accounting for dropouts to exclude the null hypothesis or ORR < 12%; an exploratory cohort (Cohort 2: 40 pts) includes platinum-ineligible pts who progress after prior CPI. The primary objective is ORR per RECIST 1.1, assessed by central review. Secondary objectives include response duration, PFS, and OS. Adverse events, pharmacokinetics, and tissue correlates will also be assessed. Enrollment began August 2018. Clinical trial information: NCT03547973

Other Abstracts in this Sub-Category:


1. First-in-human phase 1 study of ABBV-085, an antibody-drug conjugate (ADC) targeting LRRC15, in sarcomas and other advanced solid tumors.

Meeting: 2019 ASCO Annual Meeting Abstract No: 3004 First Author: George D. Demetri
Category: Developmental Therapeutics and Tumor Biology (Nonimmuno) - Immunoconjugates (non-IO)


2. Phase 1 dose escalation study of XMT-1536, a novel NaPi2b-targeting antibody-drug conjugate (ADC), in patients (pts) with solid tumors likely to express NaPi2b.

Meeting: 2019 ASCO Annual Meeting Abstract No: 3010 First Author: Anthony W. Tolcher
Category: Developmental Therapeutics and Tumor Biology (Nonimmuno) - Immunoconjugates (non-IO)


3. A phase I study of [225Ac]-FPI-1434 radioimmunotherapy in patients with IGF-1R expressing solid tumors.

Meeting: 2019 ASCO Annual Meeting Abstract No: TPS3152 First Author: Rosalyn A. Juergens
Category: Developmental Therapeutics and Tumor Biology (Nonimmuno) - Immunoconjugates (non-IO)