Final data from phase III ASCENT study demonstrates Trodelvy extends overall survival over chemotherapy in second-line metastatic triple negative breast cancer.
Gilead Sciences, Inc. presented final data from the Phase III ASCENT study of Trodelvy (sacituzumab govitecan-hziy) in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease.
In a follow-up analysis from the final database lock, Trodelvy improved median progression-free survival versus physicians’ choice of chemotherapy (4.8 vs. 1.7 months; HR: 0.41; p<0.0001) and extended median overall survival (os) by almost five months (11.8 vs. 6.9 months; hr: 0.51; p><0.0001) in the intent-to-treat population. the two-year os rate was 20.5% (95% ci: 15.4-26.1) in the trodelvy arm, compared with 5.5% (95% ci: 2.8-9.4) with physicians’ choice of chemotherapy. trodelvy also showed clinically meaningful improvements in health-related quality of life (hrqol) compared to chemotherapy. the results, which were consistent with the final analysis previously published in the new england journal of medicine, were presented at the 2022 american society of clinical oncology (asco) annual meeting (abstract #1071).
“These final data from the Phase 3 ASCENT study confirm the survival and quality of life benefit seen with sacituzumab govitecan over traditional chemotherapy in patients with pre-treated metastatic triple-negative breast cancer,” said Aditya Bardia, MD, MPH, Director of Breast Cancer Research Program, Mass General Cancer Center and Associate Professor of Medicine at Harvard Medical School, and global principal investigator of the ASCENT study. “Until now, there was a longstanding gap in effective treatment options which had a severe impact on quality of life and contributed to poor outcomes for these patients.”
Trodelvy demonstrated higher clinically meaningful improvements in all five primary HRQoL domains compared to chemotherapy, which was consistent with previous reports. Metastatic TNBC is often associated with a significant decrease in quality of life, where patients may undergo many rounds of intensive chemotherapy, and assessing impact of symptom burden is especially important in this setting. Changes from baseline for Trodelvy vs. chemotherapy were -5.8 vs. -9.4 in global health status, -4.6 vs. -13.5 in physical functioning, -8.4 vs. -18.8 in role functioning, 5.1 vs. 14.0 in fatigue, and 2.8 vs. 6.8 in pain.
“Trodelvy is the cornerstone of our solid tumor portfolio and the first and only antibody-drug conjugate to demonstrate a statistically significant improvement in overall survival and quality of life versus single-agent chemotherapy in second-line metastatic TNBC,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “These final data from ASCENT reinforce Trodelvy as a new standard-of-care option in this setting.”
The safety profile of Trodelvy was consistent with prior reports. Key Grade greater than 3 treatment-related adverse reactions for Trodelvy compared to chemotherapy were diarrhea (11% vs. <1%), neutropenia (52% vs. 33%), anemia (8% vs. 5%), and febrile neutropenia (6% vs. 2%). treatment discontinuations due to adverse events were less than 3% in both arms. the trodelvy u.s. prescribing information has a boxed warning for severe or life-threatening neutropenia and severe diarrhea.
See-"Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer"-Aditya Bardia, M.D., Sara A. Hurvitz, M.D., Sara M. Tolaney, M.D., M.P.H., et al., for the ASCENT Clinical Trial Investigators.April 22, 2021. N Engl J Med 2021; 384:1529-1541.
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