Biopharmaceutical company Immunomedics Inc. (IMMU:NASDAQ), which specializes 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." The firm advised that the decision to cancel the ASCENT trial prior to scheduled completion was made based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC) during its recent routine review of the study.
Julie R. Gralow, M.D., Jill Bennett Endowed Professor of Breast Cancer at University of Washington School of Medicine and member of the Fred Hutchinson Cancer Research Center, commented, "It is my distinct honor to have served as Chairperson of the independent DSMC for this important study...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."
The company explained that "the 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 prior defined primary endpoint for the study is progression-free survival. The main secondary endpoints were identified as overall survival and objective response rate.
The company's Chief Medical Officer Loretta M. Itri, M.D., added, "We want to thank the members of the DSMC for their guidance...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."
"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," remarked Immunomedics' Executive Chairman Dr. Behzad Aghazadeh.
The company indicated that "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 firm advised that the FDA previously granted Breakthrough Therapy Designation for sacituzumab govitecan for use in this disease indication and trial setting.
Immunomedics is a clinical-stage biopharmaceutical company headquartered in Morris Plains, N.J., that this focused on developing and advancing monoclonal antibody-based products for targeted cancer, autoimmune and other serious disease treatments. The company stated that its primary corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates.
Immunomedics began the day with a market capitalization of around $2.0 billion with approximately 213.9 million shares outstanding and a short interest of about 12.5%. IMMU shares opened 117% higher today at $20.11 (+$11.01, +117.13%) over Friday's $9.40 closing price. The stock has traded today between $17.57 and 20.20 per share and is currently trading at $18.49 (+$9.09, +96.74%).[NLINSERT]
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