Trodelvy Significantly Extends Survival in Phase 3 ASCENT Study of Metastatic Triple-Negative Breast Cancer
Trodelvy significantly reduced the risk of death by 52 percent, with a median overall survival (OS) of 12.1 months
compared to 6.7 months for standard single-agent chemotherapy
Trodelvy is the first ADC to significantly improve OS in metastatic triple-negative breast cancer (mTNBC)
sBLA for full approval to be submitted in fourth quarter 2020 under RTOR process
Company to host conference call and webcast today at 2:00 p.m. Eastern Time
MORRIS PLAINS, N.J., Sept. 19, 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 results from the confirmatory Phase 3 ASCENT study showed that Trodelvy (sacituzumab govitecan-hziy) significantly extended overall survival (OS) and improved overall response rate (ORR) and clinical benefit rate (CBR), compared to treatment of choice (TPC) standard single-agent chemotherapy in brain metastases-negative patients with mTNBC who had previously received at least two prior therapies for metastatic disease. These results will be presented today as a late-breaking abstract (Abstract# LBA17) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
“The randomized Phase 3 study results confirm that sacituzumab govitecan should be considered as a new standard of care in patients with third-line mTNBC,” stated Aditya Bardia, MD, MPH, Director of Precision Medicine at the Center for Breast Cancer, Mass General Cancer Center and Assistant Professor of Medicine at Harvard Medical School, who will give an oral presentation of the study at the ESMO Congress. “We wish to express our gratitude to the patients and their caregivers for their valuable contribution, as well as the dedicated clinical trial investigators and their devoted team members for making the ASCENT trial possible. Ongoing studies are evaluating sacituzumab govitecan in earlier lines of therapy, including the neoadjuvant and adjuvant settings, in combination with other targeted agents, and in patients with hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast cancer, which will help accelerate our efforts to further improve outcomes for patients with breast cancer.”