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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