Tanja Obradovic Highlights Positive ASCENT-03 Results for Trodelvy Ahead of ASCO 2025
Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“ASCO2025 is shaping to be quite exciting this year with many updates. One of the very exciting positive results has just been announced by Gilead Sciences with data to be presented at the meeting.
Phase III ASCENT-03 trial of Trodelvy (sacituzumab govitecan-hziy) has met its primary endpoint, showing improvement in progression-free survival (PFS) against chemotherapy (physician’s choice of gemcitabine with carboplatin, paclitaxel, or nab-paclitaxel) in patients with first-line metastatic triple-negative breast cancer (mTNBC) not positive for PDL-1 receptor. Overall survival analysis is pending after data maturation and if positive it would be major breakthrough for this patient population after decades of no major advances. Discussions with regulators are ongoing so considering agility of FDA we may see fast beadside availability and high interest in data details at ASCO2025.
Trodelvy’s role in the treatment of the breast cancer is definitively solidifying. ASCENT-03 positive outcome is coming just one month after positive Phase III ASCENT-04/KEYNOTE-D19 trial of Trodelvy and Merck’s Keytruda combo in patients with inoperable locally advanced or metastatic triple-negative breast cancer positive for PDL-1 receptor.
In addition, Trodelvy is the only antibody-drug conjugate (ADC) with four positive Phase III trials in HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) metastatic breast cancer (mBC), and remains the only approved Trop-2-directed ADC that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers: 2L mTNBC and pre-treated HR+/HER2- mBC.”
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