Novel Antibody Drug-Conjugate in Metastatic Triple-Negative Breast Cancer
Posted: Wednesday, April 3, 2019
Sacituzumab govitecan-hziy yielded a response rate of 33% for patients with previously treated triple-negative breast cancer, with just 3% of patients discontinuing treatment because of adverse effects, according to the results of a new trial. Sacituzumab govitecan-hziy consists of SN-38, the metabolic product of irinotecan, attached to an antibody that recognizes and targets the trop2 protein expressed by breast cancer cells. The research was published in the The New England Journal of Medicine by Kevin Kalinksy, MD, MS, of Columbia University and NewYork–Presbyterian, and colleagues.
“We saw significant tumor shrinkage with the new drug,” said Dr. Kalinsky in a press release from Columbia University. “With this smart drug, we can deliver a much higher dose of the payload since we’re sending it directly to the cancer cells.”
The phase1/2, multicenter trial treated 108 patients with metastatic triple-negative breast cancer. Patients had received between 2 and 10 previous treatment regimens, with a median of 3. All patients received sacituzumab govitecan-hziy intravenously.
The response rate was 33%, and the clinical benefit rate (defined as a complete or partial response or stable disease for at least 6 months) was 45%. The median response duration was 7.7 months, median progression-free survival was 5.5 months, and overall survival was 13.0 months. The most common adverse effects of grade 3 or 4 were neutropenia, anemia, decreased white blood cell count, hypophosphatemia, diarrhea, and fatigue. A total of 3% of patients discontinued treatment because of adverse effects.
“It is promising to have an active treatment that does not have neuropathy as a side effect,” said Dr. Kalinsky. Sacituzumab govitecan-hziy has less likelihood of severe adverse effects than irinotecan, the authors noted. A randomized phase II/III clinical trial comparing this agent with other drugs is underway.
Disclosure: The study authors’ disclosure information may be found at nejm.org.
