Immunomedics Announces Positive Results from Pivotal Phase 2 TROPHY U-01 Study of Trodelvy in Metastatic Urothelial Cancer
Trodelvy achieves a 27 percent overall response rate and a 5.9-month median duration of response in heavily-pretreated patients with metastatic urothelial cancer (mUC)
sBLA submission for accelerated approval expected in fourth quarter 2020, pending FDA final guidance
Phase 3 TROPiCS-04 study in third-line mUC underway
Company to host conference call and webcast today at 2:00 p.m. Eastern Time
MORRIS PLAINS, N.J., Sept. 19, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced positive results from cohort 1 of cisplatin-eligible patients in the pivotal Phase 2 TROPHY U-01 study of Trodelvy (sacituzumab govitecan-hziy) in metastatic urothelial cancer (mUC). Results confirm the interim findings and prior Phase 1/2 study results showing Trodelvy has significant activity and is safe in patients with heavily-pretreated mUC who progressed on both platinum-based chemotherapy and checkpoint inhibitors (CPI).
“Given that only about 10 percent of patients with mUC who have cancer progression after platinum-based and CPI therapy are expected to respond to single-agent chemotherapy with approximately two to three months of median progression-free survival, today’s compelling results with sacituzumab govitecan offer patients and families new hope,” commented Yohann Loriot, MD, PhD, Institut de Cancérologie Gustave Roussy, Villejuif, France, who gave the late-breaking oral presentation of the pivotal study at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Results for cohort 1 of TROPHY U-01 are summarized in the table below. As of data cutoff on May 18, 2020, eight of the 31 responders have an ongoing response and remain on treatment. Trodelvy has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in this indication.
|Parameter||Cohort 1 (N=113)|
|Median prior anticancer regimens, n (range)||3.0 (1–8)|
|Overall response rate*, n (%) [95% CI]||31 (27) [19, 37]|
|Complete response, n (%)||6 (5)|
|Partial response, n (%)||25 (22)|
|Median duration of response*, months [95% CI] (Range)||5.9 [4.70, 8.60] (1.4–11.7)|
|Median time to onset of response*, months (Range)||1.6 (1.2–5.5)|
|Median progression-free survival, months (95% CI)||5.4 (3.5, 6.9)|
|Median overall survival, months (95% CI)||10.5 (8.2, 12.3)|
* Based on blinded independent central assessment per RECIST v1.1