Benzinga | Sep 20, 2020 08:48AM EDT

Immunomedics Announced Positive Results from Pivotal Phase 2 TROPHY U-01 Study of Trodelvy in Metastatic Urothelial Cancer at ESMO 2020

Immunomedics, Inc. (NASDAQ:IMMU) announced Saturday 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 Cancrologie 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 (18)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] (1.411.7)Median time to onset of response*, months (Range) 1.6 (1.25.5)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

"We believe that Trodelvy may offer a new treatment option for patients with mUC based on the successful data readout today," remarked Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics. "While we are seeking guidance from the FDA on the registrational pathway, the new Phase 3 TROPiCS-04 study in third-line mUC has been reviewed by FDA, is under review by the European Medicines Agency, and is currently in initiation phase."

Trodelvy continued to demonstrate a tolerable and predictable safety profile consistent with previous observations in mUC and other tumor types. Treatment-related Grade 3 and 4 adverse events were mostly hematologic and gastrointestinal related, including neutropenia (34%) and diarrhea (10%). Seven patients (6%) discontinued treatment due to adverse events, three of whom due to neutropenia or its complications. There was one treatment-related death from sepsis due to febrile neutropenia. There were no grade 2 or above events of neuropathy or rash, and no cases of interstitial lung disease reported.

Conference Call

The Company will host a conference call and live audio webcast with key opinion leaders today at 2:00 p.m. Eastern Time to discuss theTROPHY U-01 results and provide a corporate update. To access the conference call supported with slides, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 1871157. The conference call with supporting slides will be webcast via the Investors page on the Company's website at https://immunomedics.com/investors/. Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company's website for approximately 30 days.