TROPHY-u-01 Trial: A Phase II Open-Label Study Of Sacituzumab Govitecan (IMMU-132) In Patients With Advanced Urothelial Cancer

TROPHY-u-01 Trial: A Phase II Open-Label Study Of Sacituzumab Govitecan (IMMU-132) In Patients With Advanced Urothelial Cancer

Annual-Meeting

6 months
178 Views
Share
Want to watch this again later?
Sign in to add this video to a playlist. Login
0 0
Category:
Description:
Scott Tagawa MD @drscottagawa Of Weill Cornell Medicine and NewYork-Presbyterian Discusses TROPHY-u-01 Trial: A Phase II Open-Label Study Of Sacituzumab Govitecan (IMMU-132) In Patients With Advanced Urothelial Cancer. BACKROUND: 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 16) 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
Up Next Autoplay
Zomas Question 2
Zomas Question 2
Category: Chronic Myelogenous Leukemia
0 Views
admin 4 hours
4-Year Update of the Echelon-1 Study #ASH19 #ASH @TakedaOncology
4-Year Update of the Echelon-1 Study #ASH19 #ASH @TakedaOncology
Category: Chronic Lymphocytic Leukemia
3 Views
ash 6 hours
SWAY Study @LevineCancer #ASH19
SWAY Study @LevineCancer #ASH19
Category: Chronic Lymphocytic Leukemia
0 Views
ash 7 hours
Sickle Cell Research: What's Next? #ASH19 #ASH @LevineCancer
Sickle Cell Research: What's Next? #ASH19 #ASH @LevineCancer
Category: Chronic Lymphocytic Leukemia
0 Views
admin 8 hours
Unmet Needs in Sickle Cell Research #ASH19 #ASH @LevineCancer
Unmet Needs in Sickle Cell Research #ASH19 #ASH @LevineCancer
Category: Chronic Lymphocytic Leukemia
0 Views
ash 8 hours
Phase 2 CAPTIVATE Trial: What's Next? #ASH19 #ASH @PeterMacCC
Phase 2 CAPTIVATE Trial: What's Next? #ASH19 #ASH @PeterMacCC
Category: Chronic Lymphocytic Leukemia
0 Views
ash 9 hours
Phase 2 CAPTIVATE clinical trial in CLL #ASH19 #ASH @PeterMacCC
Phase 2 CAPTIVATE clinical trial in CLL #ASH19 #ASH @PeterMacCC
Category: Chronic Lymphocytic Leukemia
0 Views
ash 9 hours
Update on Phase I REGN1979 #ASH19 #ASH @RutgersCancer
Update on Phase I REGN1979 #ASH19 #ASH @RutgersCancer
Category: Non-Hodgkin Lymphoma
4 Views
ash 23 hours
REGN5458 @RutgersCancer #ASH #ASH19
REGN5458 @RutgersCancer #ASH #ASH19
Category: Multiple Myeloma
6 Views
ash 23 hours
Phase 3 ICARIA-MM trial of isatuximab #ASH19 #ASH @sanofi
Phase 3 ICARIA-MM trial of isatuximab #ASH19 #ASH @sanofi
Category: Multiple Myeloma
6 Views
ash 1 day