IMMUNOMEDICS ANNOUNCES ASCENT STUDY TO BE STOPPED FOR COMPELLING EFFICACY

Decision based on recommendation from DSMC following study data review

Sacituzumab govitecan has the potential to be the first FDA-approved antibody-drug conjugate for the treatment of metastatic triple-negative breast cancer

Conference call and webcast today at 8:00 a.m. Eastern Time

MORRIS PLAINS, N.J., April 06, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that its Phase 3 confirmatory ASCENT study will be halted due to compelling evidence of efficacy. This decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC), during its recent routine review of the ASCENT study.

“It is my distinct honor to have served as Chairperson of the independent DSMC for this important study,” remarked Julie R. Gralow, MD, Jill Bennett Endowed Professor of Breast Cancer, University of Washington School of Medicine; Member, Fred Hutchinson Cancer Research Center. “Triple-negative breast cancer (TNBC) is a disease with extremely limited treatment options beyond classic chemotherapy. The remarkable results we observed across multiple endpoints in the ASCENT study warranted early discontinuation of the trial and are indicative of a potential major advance in the treatment of this devastating disease that affects younger women and African American women at higher rates. I look forward to the release of the full and final analyses of these study data when they are available for public presentation.”

ASCENT is a Phase 3 confirmatory study designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a Phase 2 study of heavily pretreated patients with metastatic TNBC (mTNBC). The primary endpoint for the study is progression-free survival, and secondary endpoints include overall survival and objective response rate, among others.

“We want to thank the members of the DSMC for their guidance,” said Loretta M. Itri, MD, Chief Medical Officer of Immunomedics. “This strengthens our resolve to complete the analysis and reporting of the final study results, thereby allowing these data to become available to physicians caring for the TNBC community in a timely fashion.”

Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics, commented, “Today’s announcement marks a significant milestone towards fulfilling our promise to patients globally with TNBC of providing a new treatment option that can meaningfully improve their lives. We are grateful to all the patients, their families and healthcare providers who participated in the ASCENT study. On behalf of all of my colleagues at Immunomedics, we remain committed to working tirelessly to bring this potentially transformative drug to all mTNBC patients in need.”