ASCENT
Sacituzumab govitecan versus single-agent chemotherapy of physician's choice in relapsed or refractory metastatic triple-negative breast cancer
Phase 3N = 529NCT02574455
- Population
- Relapsed or refractory metastatic triple-negative breast cancer; all patients in the primary report had previous taxane treatment
- Design
- Randomised 1:1 phase 3 trial of sacituzumab govitecan versus single-agent chemotherapy of the physician's choice (eribulin, vinorelbine, capecitabine or gemcitabine). Primary endpoint PFS by blinded independent central review among patients without brain metastases (468 patients: 235 and 233). Final analysis reported in the full randomised population (529 patients, including those with brain metastases). Registry record: open-label.
- Primary endpoint
- PFS
- Arms
- Sacituzumab govitecan (experimental, n = 267): Sacituzumab govitecan
- Single-agent chemotherapy of physician's choice (control, n = 262): Eribulin, vinorelbine, capecitabine or gemcitabine
- People
- Bardia A, senior author Rugo HS, ASCENT Clinical Trial Investigators
PFSHR 0.41 (95% CI 0.32–0.52)Δ median PFS+3.9 monthsOSHR 0.48 (95% CI 0.38–0.59)Δ median OS+5.4 monthsΔ ORR+30 pointsPFSHR 0.41 (95% CI 0.33–0.52)
Show the numbers
| Endpoint | Analysis | Sacituzumab govitecan | Single-agent chemotherapy of physician's choice | Effect |
|---|---|---|---|---|
| PFSPatients without brain metastases (primary analysis population)Blinded independent central review | primaryBardia 2021 | median 5.6 months (4.3–6.3) | median 1.7 months (1.5–2.6) | HR 0.41 (95% CI 0.32–0.52)P<0.001166 events with sacituzumab govitecan and 150 with chemotherapy. Randomised patients without brain metastases: 235 and 233. Grade 3 or higher treatment-related neutropenia 51% vs 33%, diarrhea 10% vs <1%. |
| OSPatients without brain metastases (primary analysis population) | primaryBardia 2021 | median 12.1 months (10.7–14.0) | median 6.7 months (5.8–7.7) | HR 0.48 (95% CI 0.38–0.59)P<0.001Reported in the primary publication; the abstract does not label OS as interim or final. |
| ORRPatients without brain metastases (primary analysis population) | primaryBardia 2021 | 35% | 5% | Percentage with an objective response, as published (rounded to whole numbers). |
| PFSFull randomised population (final analysis) | finalBardia 2024 | median 4.8 months | median 1.7 months | HR 0.41 (95% CI 0.33–0.52)Final analysis of secondary endpoints; the full randomised population included patients with and without baseline brain metastases (N = 529, per the open-access full text). |
| OSFull randomised population (final analysis) | finalBardia 2024 | median 11.8 months | median 6.9 months | HR 0.51 (95% CI 0.42–0.63) |
| Endpoint | Analysis | Sacituzumab govitecan | Single-agent chemotherapy of physician's choice | Effect |
|---|---|---|---|---|
| PFSPatients without brain metastases (primary analysis population)Blinded independent central review | primaryBardia 2021 | median 5.6 months (4.3–6.3) | median 1.7 months (1.5–2.6) | HR 0.41 (95% CI 0.32–0.52)P<0.001166 events with sacituzumab govitecan and 150 with chemotherapy. Randomised patients without brain metastases: 235 and 233. Grade 3 or higher treatment-related neutropenia 51% vs 33%, diarrhea 10% vs <1%. |
| OSPatients without brain metastases (primary analysis population) | primaryBardia 2021 | median 12.1 months (10.7–14.0) | median 6.7 months (5.8–7.7) | HR 0.48 (95% CI 0.38–0.59)P<0.001Reported in the primary publication; the abstract does not label OS as interim or final. |
| ORRPatients without brain metastases (primary analysis population) | primaryBardia 2021 | 35% | 5% | Percentage with an objective response, as published (rounded to whole numbers). |
| PFSFull randomised population (final analysis) | finalBardia 2024 | median 4.8 months | median 1.7 months | HR 0.41 (95% CI 0.33–0.52)Final analysis of secondary endpoints; the full randomised population included patients with and without baseline brain metastases (N = 529, per the open-access full text). |
| OSFull randomised population (final analysis) | finalBardia 2024 | median 11.8 months | median 6.9 months | HR 0.51 (95% CI 0.42–0.63) |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.41 | 0.32–0.52 |
| OS | 0.48 | 0.38–0.59 |
| PFS | 0.41 | 0.33–0.52 |
| OS | 0.51 | 0.42–0.63 |
- Sacituzumab govitecan (experimental)
- Single-agent chemotherapy of physician's choice (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Sacituzumab govitecan | Single-agent chemotherapy of physician's choice |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 4 | 61.0% | 19.6% |
| 7 | 42.0% | 5.8% |
| 11 | 25.6% | 1.1% |
| 14 | 17.7% | 0.3% |
- Sacituzumab govitecan (experimental)
- Single-agent chemotherapy of physician's choice (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Sacituzumab govitecan | Single-agent chemotherapy of physician's choice |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 8 | 63.2% | 43.7% |
| 15 | 42.3% | 21.2% |
| 23 | 26.8% | 9.3% |
| 30 | 17.9% | 4.5% |
Appears in
Sources
Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, et al. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021;384(16):1529-1541.
Bardia A, Rugo HS, Tolaney SM, Loirat D, Punie K, Oliveira M, et al. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024;42(15):1738-1744.