Gilead Sciences’ randomised, global Phase III ASCENT-03 trial of Trodelvy (sacituzumab govitecan-hziy) has met its primary endpoint, showing improvement in progression-free survival (PFS) against chemotherapy in individuals with first-line metastatic triple-negative breast cancer (mTNBC).
These subjects are PD-L1 negative or are not eligible to receive immunotherapy.
The open-label, Phase III trial is assessing the efficacy and safety of sacituzumab govitecan. Nearly 540 patients were enrolled across various trial sites worldwide.
Subjects were randomised in a 1:1 ratio and given either sacituzumab govitecan (10mg/kg intravenously on days one and eight of a 21-day cycle) or treatment of physician’s choice, which included gemcitabine with carboplatin, paclitaxel, or nab-paclitaxel.
Treatment progressed till blinded independent central review (BICR)-verified disease progression or unacceptable toxicity was observed.
Patients randomised to chemotherapy were said to be eligible to crossover to the therapy upon progression of the disease.
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By GlobalDataThe safety profile of the therapy in the trial was found to be consistent with previous trials, without any safety signals observed.
While overall survival (OS) is a key secondary endpoint, it was immature at the time of the PFS primary analysis, and no OS detriment was identified.
The detailed data from the trial is set to be shared at the American Society of Clinical Oncology (ASCO) meeting from 30 May to 3 June 2025.
Gilead noted that it will monitor OS outcomes with ongoing follow-up and additional analysis planned.
Gilead is conducting additional Phase III trials evaluating the therapy across various types of breast cancer, including the ASCENT-07 pivotal trial in those with HR+/HER2- mBC who have received endocrine therapy, and the ASCENT-05 pivotal trial in subjects with early-stage TNBC (eTNBC).
Trodelvy is also under assessment in additional Phase III trials across a range of tumour types, including gynaecologic and lung cancers.
Gilead Sciences chief medical officer Dietmar Berger said: “The ASCENT-03 outcome represents the first clinically meaningful advance for this patient population in over 20 years versus chemotherapy.”
This April, Gilead announced positive topline data from the Phase III ASCENT-04/KEYNOTE-D19 trial of Trodelvy and MSD’s Keytruda combo in individuals with inoperable locally advanced or metastatic triple-negative breast cancer.
