Gilead's Trodelvy scores 'surprise' OS win in metastatic breast cancer, but data will wait for an upcoming conference
Gilead Sciences said Monday morning that Trodelvy is the first TROP-2 directed ADC to show statistically significant and “clinically meaningful” results in overall survival from a second interim analysis of a Phase 3 trial in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemo.
The announcement surprised Wall St analysts after Gilead unveiled less than stellar OS results after the first interim analysis at ASCO in June. But now, Gilead said it submitted an sBLA to FDA for this new breast cancer indication, but it also said it won’t present the actual OS data from the second interim analysis until an unidentified upcoming medical conference.
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