On February 11, 2019 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that updated data with longer follow-up on sacituzumab govitecan, its lead investigational ADC, in patients with metastatic urothelial cancer (mUC) who have relapsed or are refractory to chemotherapies and immune checkpoint inhibitors (CPIs), have been accepted for an oral presentation at this year’s Genitourinary Cancers Symposium (ASCO-GU) (Press release, Immunomedics, FEB 11, 2019, View Source [SID1234533208]).
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As reported in the abstract released online, sacituzumab govitecan produced an overall response rate (ORR) of 31 percent in 45 heavily-pretreated mUC patients, with an encouraging median duration of response of 12.6 months and median progression-free survival of 7.3 months. Consistent with prior reports, the updated safety profile demonstrates that sacituzumab govitecan is generally well tolerated and manageable relative to other available therapies. Further data on subgroups will be presented at the meeting.
"Despite the late-stage setting, sacituzumab govitecan continues to show promising activity in patients who failed current standard of care for mUC," said Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics. "We believe these results support further investigation in a pivotal Phase 2 TROPHY U-01 study.
The trial design of TROPHY U-01 is the subject of the second presentation at ASCO (Free ASCO Whitepaper)-GU. Details of the two presentations are listed below (all times are in Pacific Time):
Friday, February 15, 2019
Sacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a Phase I/II study (Tagawa, et al.)
Oral Abstract Session B: Urothelial Carcinoma & Penile, Urethral, Testicular, & Adrenal Cancer
Abstract # 354
1:45 pm – 1:55 pm
Level 3 – Ballroom
Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, Testicular, and Adrenal Cancers
Board B5
12:15 pm -1:45 pm and 5:15 pm – 6:15 pm
Level 1 – West Hall
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 (Tagawa, et al.)
Trials in Progress Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, Testicular, and Adrenal
Abstract TPS495
Board N5
12:15 pm -1:45 pm and 5:15 pm – 6:15 pm
Level 1 – West Hall