On April 6, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates, reported that its Phase 3 confirmatory ASCENT study will be halted due to compelling evidence of efficacy (Press release, Immunomedics, APR 6, 2020, View Source [SID1234556159]). 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.
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"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."
A biologics license application resubmission seeking accelerated approval of sacituzumab govitecan for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease is currently under U.S. Food and Drug Administration (FDA) review, with a PDUFA target action date of June 2, 2020. The FDA previously granted Breakthrough Therapy Designation for sacituzumab govitecan in this disease setting.
Conference Call
The Company will host a conference call and live audio webcast today at 8:00 a.m. Eastern Time to provide a clinical development and general corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 8348877. The conference call will be webcast via the Investors page on the Company’s website at View Source 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.