Progression-free survival was not statistically significant with Trodelvy versus chemotherapy as first-line treatment in HR+/HER2– metastatic breast cancer.
Among patients with hormone-receptor-positive/HER2-negative breast cancer, progression-free survival (PFS) was not statistically significant with Trodelvy (sacituzumab govitecan-hziy) after endocrine therapy versus chemotherapy, according to updated results from the phase 2 ASCENT-07 study presented at the 2025 San Antonio Breast Cancer Symposium (SABCS).
The median PFS by blinded independent central review in the Trodelvy arm was 8.3 months versus 8.3 months in the chemotherapy arm. At six months, the PFS rate was 71% versus 64%, while the 12-month rates were 40% versus 37%, respectively.
The median PFS by investigator assessment was 8.4 months in the Trodelvy arm versus 6.4 months in the chemotherapy arm. The six-month PFS rate was 69% versus 58%, and the 12-month PFS rate was 36% versus 30% between both arms, respectively.
Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without the disease getting worse. It shows how well a treatment can keep the cancer from growing or spreading.
Overall Survival (OS): The length of time from diagnosis or the start of treatment that a patient is still alive, no matter what happens with the cancer itself. It is often used to understand how effective a treatment is at helping patients live longer.
The overall survival (OS) in the primary analysis had a 27% maturity. The median OS was not reached (NR) in the Trodelvy arm versus NR in the chemotherapy arm. Of note, 61% of patients in the chemotherapy group were given Trodelvy after treatment discontinuation. The investigators noted that while the data were not mature, an early trend was observed favoring Trodelvy over chemotherapy.
“The ASCENT-07 study in participants with hormone receptor-positive/HER2-negative metastatic breast cancer eligible for first [line] chemotherapy did not meet statistical significance for the primary end point of PFS by BICR,” lead study author Dr. Komal Jhaveri, section head of the Endocrine Therapy Research Program, clinical director of Early Drug Development Services, and the Patricia and James Cayns Chair for Junior Faculty at Memorial Sloan Kettering Cancer Center in New York, said during the presentation.
A total of 690 patients were randomly assigned to receive either intravenous Trodelvy (456 patients) at 10 mg/kg on days 1, 8 and 21; in the chemotherapy arm (234 patients), the physician gave patients either capecitabine, paclitaxel or nab-paclitaxel.
The data cutoff for the primary PFS analysis was Sept. 15, 2025. At that time, there were 419 PFS events observed with a 61% maturity, and 187 OS events with a 27% maturity. The median duration of follow-up was 15.4 months.
In the Trodelvy arm, the median duration of treatment was 8.3 months versus 6.1 months in the chemotherapy arm. The median relative dose intensity was 86.2% versus 93%.
Any treatment-emergent side effects occurred in more than 99% of patients in the Trodelvy arm versus 97% in the chemotherapy arm, and grade 3 (severe) or higher treatment-emergent side effects in 72% versus 48%. Treatment-emergent serious side effects were noted in 23% versus 15%. Additionally, treatment-emergent side effects leading to discontinuation occurred in 3% versus 7%, dose interruption in 75% versus 46%, dose reduction in 39% versus 38% and death in 2% versus 2%.
Treatment-related side effects were noted in more than 99% of patients in the Trodelvy arm versus 93% in the chemotherapy arm, with grade 3 or higher treatment-related side effects in 68% versus 37%. Treatment-related serious side effects occurred in 16% versus 5% of patients. Additionally, treatment-related side effects leading to death occurred in 1% versus 1%.
“[Trodelvy] remains a standard of care for hormone-receptor–positive/HER2-negative metastatic breast cancer after prior endocrine therapy and chemotherapy based on the phase 3 TROPiCS-02 study,” Jhaveri concluded.
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