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Trodelvy® significantly improves survival in second-line or later metastatic triple-negative breast cancer (mTNBC) when compared with single-agent chemotherapy.1
Median progression-free survival (PFS) with Trodelvy® was three times longer than with single-agent chemotherapy treatment of physician's choice.1,2
Primary endpoint: PFS in patients without known brain metastases.1
Adapted from Bardia, et al. 2021.1
The PFS results in the full population (N=529; with or without known brain metastases) were consistent with the population without known brain metastases (median PFS: 4.8 months [95% CI: 4.1–5.8] with Trodelvy® vs 1.7 months [95% CI: 1.5–2.5] with single-agent chemotherapy [HR: 0.43; 95% CI: 0.35–0.54; p<0.0001]).1
An exploratory subgroup analysis of PFS in patients with brain metastases (n=61) showed a PFS with Trodelvy® of 2.8 months vs 1.6 months for single-agent chemotherapy (HR: 0.65; 95% CI: 0.35–1.22).2
As per approved labelling, single-agent chemotherapy was determined by the investigator before randomisation from one of the following regimens: eribulin, vinorelbine, capecitabine, and gemcitabine.1
Median overall survival (OS) with Trodelvy® was almost twice as long versus single-agent chemotherapy treatment of physician's choice.1-3 OS was a secondary endpoint.1
OS in patients without known brain metastases1
Adapted from Bardia, et al. 2021.1
The OS results in the full population (n=529; with or without known brain metastases) were consistent with the population without known metastases (median OS: 11.8 months [95% CI: 10.5–13.8) with Trodelvy® vs 6.9 months with single-agent chemotherapy [HR: 0.51; 95% CI, 0.41–0.62).1
An exploratory analysis of OS in patients with brain metastases (n=61) demonstrated no improvement in median OS: 6.8 months with vs 7.5 months with single-agent chemotherapy (HR: 0.87; 95% CI: 0.47–1.63).2
Trodelvy® delivered a seven times greater objective response rate (ORR) than single-agent chemotherapy.1,2
ORR was a secondary endpoint.1
Adapted from Bardia, et al. 2021.1
*These waterfall plots illustrate the best percentage change from baseline in the sum of the diameters of target lesions (longest diameter for non-nodal lesions and short axis for nodal lesions) in patients without brain metastases who had at least one response assessment.
The ASCENT trial was an international, multicentre, open-label, randomised, phase 3 study to investigate Trodelvy® in patients with unresectable locally advanced or mTNBC who had relapsed after at least 2 prior lines of chemotherapy (one of which could be in the neoadjuvant or adjuvant setting provided progression occurred within a 12-month period after completion of treatment).3
Patients were stratified at randomisation according to the number of previous chemotherapy regimens for advanced disease (2 or 3 vs >3), the presence of known brain metastases at baseline (yes vs no), and geographic region (North America vs rest of the world).1
*As per approved labelling. Single-agent chemotherapy was determined by the investigator before randomisation from one of the following regimens: eribulin, vinorelbine, capecitabine and gemcitabine.1
†PFS was assessed by blinded independent central review based on RECIST 1.1 criteria in patients without known brain metastases (N=468).1
In ASCENT, demographics and baseline characteristics were well matched between groups.1
*Patients in the trial either had TNBC at initial diagnosis or hormone receptor-positive disease that converted to hormone-negative at time of trial entry.
†Anticancer regimens refer to any previous regimens for metastatic or locally advanced disease or in the neoadjuvant context that were used to treat an eligible patient with breast cancer. Previous therapy in the adjuvant context is excluded from this count.
‡Includes paclitaxel, nab-paclitaxel, and docetaxel.
§Includes doxorubicin, daunorubicin, epirubicin, and different formulations of these agents.
¶Based on independent central review of target and nontarget lesions.
May 2025 UKI-TRO-0270
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