Phase 3 ASCENT Study in patients with mTNBC meets primary endpoint
The Phase 3 ASCENT study of sacituzumab govitecan-hziy (Trodelvy) met its primary endpoint of progression-free survival (PFS) in previously-treated brain metastasis negative patients with advanced Metastatic Triple-Negative Breast Cancer (mTNBC) who have previously received at ≥2 prior therapies for metastatic disease, according to a press release from IImmunomedics, Inc.
Sacituzumab govitecan-hziy significantly improved PFS compared to chemotherapy, with a median PFS of 5.6 months in patients treated with sacituzumab govitecan-hziy compared to 1.7 months for chemotherapy.
The safety profile was observed to be consistent with the U.S. Food and Drug Administration-approved label.
“The results of the global Phase 3 ASCENT study confirm our initial observations that sacituzumab govitecan has the potential to change the standard management of mTNBC. Based on these data, sacituzumab govitecan has set a new benchmark in scientific and clinical innovation for patients with mTNBC by offering a novel alternative to the common drugs currently in clinical practice. Importantly, the ASCENT topline data also validate the manageable safety profile of sacituzumab govitecan, rendering it a good partner candidate for combination with other therapies, including immunotherapy,” stated the study principal investigator, 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, in the press release.
Read the full press release here.