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, NJ, USA I September 19, 2020 I 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

“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.

About Immunomedics

Immunomedics is a leader in next-generation antibody-drug conjugate (ADC) technology, committed to help transform the lives of people with hard-to-treat cancers. Our proprietary ADC platform centers on using a novel linker that does not require an enzyme to release the payload to deliver an active drug inside the tumor cell and the tumor microenvironment, thereby producing a bystander effect. Trodelvy, our lead ADC, is the first ADC the FDA has approved for the treatment of people with metastatic triple-negative breast cancer and is also the first FDA-approved anti-Trop-2 ADC. For additional information on the Company, please visit its website at https://immunomedics.com/. The information on its website does not, however, form a part of this press release.

SOURCE: Immunomedics

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