Overview of the ASCENT Trial and Trodelvy
The ASCENT Trial (NCT02574455) is a Phase III study that compares Trodelvy (Sacituzumab Govitecan), a targeted cancer drug, to standard chemotherapy chosen by doctors (TPC). For instance, it focused on patients with metastatic triple-negative breast cancer (mTNBC) who had tried at least two prior treatments. As a result, the trial shows Trodelvy improves survival and quality of life, offering hope for this aggressive cancer.
Key Results from the ASCENT Trial and Trodelvy
1. Longer Progression-Free Survival
Trodelvy extended the time before cancer worsened to 4.8 months, while TPC achieved only 1.7 months (hazard ratio [HR]: 0.41; p<0.0001). Therefore, Trodelvy delays disease progression significantly.
2. Better Overall Survival
Patients on Trodelvy lived a median of 11.8 months, compared to 6.9 months with TPC (HR: 0.51; p<0.0001). Furthermore, the two-year survival rate was 20.5% (95% CI: 15.4–26.1) for Trodelvy, but only 5.5% (95% CI: 2.8–9.4) for TPC.
3. Improved Quality of Life
Quality of life was measured with the EORTC QLQ-C30 survey in 419 patients (236 Trodelvy; 183 TPC). For example, Trodelvy did better than TPC in:
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Overall health (0.7 vs. -3.4)
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Physical ability (1.3 vs. -4.4)
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Emotional well-being (3.3 vs. -0.5)
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Reduced issues with fatigue (2.0 vs. 7.1), pain (-8.9 vs. -1.9), shortness of breath (-3.8 vs. 4.0), and sleep problems (-4.7 vs. 0.3).
However, diarrhea was worse with Trodelvy (14.1 vs. -1.3). Despite this, it did not harm overall quality of life.
4. How the ASCENT Trial and Trodelvy Was Set Up
The trial included patients with a median age of 54 years who had tried four prior treatments. They received either Trodelvy (10 mg/kg IV on days 1 and 8, every 21 days) or TPC (drugs like capecitabine or eribulin). Meanwhile, quality-of-life data were studied for cycles 2 to 6 using statistical models to track changes from the start.
5. Why These Results Matter
Trodelvy’s benefits in survival and quality of life make it a strong option for mTNBC after initial treatments fail. Consequently, it earns a high score on the ESMO Magnitude of Clinical Benefit Scale, helping doctors and health systems prioritize it.
How Trodelvy Works
Trodelvy links a Trop-2 antibody to SN-38, a cancer-killing drug, using a breakable connector. As a result, it targets cancer cells directly and spares healthy ones, reducing side effects.
How Trodelvy Is Given
Trodelvy is given through a vein on days 1 and 8 of a 21-day cycle. The first dose takes three hours, but later doses may take one to two hours if tolerated. For example, it’s delivered via a drip in the hand or arm, depending on the patient’s veins.
FDA Approval of Trodelvy
On April 7, 2022, the FDA approved Trodelvy for mTNBC patients who had two or more prior treatments, including one for metastatic disease. Initially, it received temporary approval in 2020, but the ASCENT Trial’s results confirmed its value.
Importance of the ASCENT Trial of Trodelvy for Triple-Negative Breast Cancer
The ASCENT Trial highlights Trodelvy’s ability to help patients with mTNBC, a cancer with few treatment options. Therefore, its success in extending life and improving well-being supports its use earlier, especially after one or two prior treatments.
Sponsor: Gilead Sciences, Inc.
Gilead Sciences, Inc., based in Foster City, California, funded the ASCENT Trial. The company works on new treatments for cancer and other serious diseases, operating in over 35 countries.
About the Author
Kevin Punie, MD, is a cancer specialist at University Hospitals Leuven Cancer Institute, Belgium. He studies metastatic breast cancer and is part of the ASCENT Trial team. Additionally, he is active in ESMO, BSMO, and EORTC.
References
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NIH National Cancer Institute – Clinical Trials Using Sacituzumab Govitecan. NIH Clinical Trials Information, 2022.
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NIH National Cancer Institute – Sacituzumab Govitecan Earns Full Approval for Triple-Negative Breast Cancer. NIH Cancer Currents Blog, May 12, 2021.
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Breast Cancer Now The Research & Care Charity –
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Sacituzumab govitecan (Trodelvy) – Breast Cancer Now The Research & Care Charity Targeted (Biological) Therapy, February 2022.
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The New England Journal of Medicine – Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer, The New England Journal of Medicine Original Article, April 22, 2021
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Trodelvy (Sacituzumab Govitecan): SABCS 2022 Sara Tolaney vs Chemo TROPiCS-02
