Gilead’s Trodelvy scores ‘surprise’ OS win in metastatic breast cancer, but data will wait for an upcoming conference – Endpoints News

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.

“These sur­vival re­sults from the TROP­iCS-02 study are im­por­tant for the breast can­cer com­mu­ni­ty and we are en­cour­aged by the po­ten­tial this may have in help­ing pa­tients who oth­er­wise have lim­it­ed al­ter­na­tives,” said Mer­dad Parsey, CMO of Gilead, in a state­ment. “We look for­ward to dis­cussing these re­sults with glob­al health au­thor­i­ties, as pre-treat­ed HR+/HER2- metasta­t­ic dis­ease pa­tients cur­rent­ly have lim­it­ed treat­ment op­tions and poor qual­i­ty of life.”

Hor­mone re­cep­tor-pos­i­tive/hu­man epi­der­mal growth fac­tor re­cep­tor 2-neg­a­tive (HR+/HER2-) breast can­cer is the most com­mon type of breast can­cer and ac­counts for ap­prox­i­mate­ly 70% of all new cas­es, or near­ly 400,000 di­ag­noses world­wide each year. But al­most 1 in 3 cas­es of ear­ly-stage breast can­cer be­come metasta­t­ic, and among pa­tients with HR+/HER2- metasta­t­ic dis­ease, the five-year rel­a­tive sur­vival rate is 30%, ac­cord­ing to Gilead.

An­a­lysts with SVB Se­cu­ri­ties added that “We ex­pect FDA to ap­prove Trodelvy for HR+/HER2- mBC, but we need to see OS da­ta to as­sess its com­pet­i­tive pro­file vs. AZN’s (OP, Berens) En­her­tu.”

RBC Cap­i­tal Mar­kets said in an in­vestor note that most in­vestors had writ­ten off the re­sults for Trodelvy in this in­di­ca­tion af­ter PFS da­ta came in “pos­i­tive but with un­cer­tain clin­i­cal mean­ing­ful­ness back in March,” adding to­day:

This morn­ing’s an­nounce­ment that TROP­iCS-02 showed sta­tis­ti­cal­ly sig­nif­i­cant, and re­port­ed­ly clin­i­cal­ly mean­ing­ful, OS ben­e­fits in a sec­ond in­ter­im analy­sis GILD has tak­en of the tri­al for on­col­o­gy drug Trodelvy in a key metasta­t­ic breast can­cer in­di­ca­tion, is a sur­prise win for the com­pa­ny, as we be­lieve the mar­ket had most­ly writ­ten off the drug in this in­di­ca­tion.

OS at the first in­ter­im analy­sis was 13.9 months for Trodelvy, com­pared with 12.3 months for chemo, RBC an­a­lysts al­so not­ed, adding that the dif­fer­ence was “like­ly short of the bar for clin­i­cal mean­ing­ful­ness at that point.”

Trodelvy sales in 2021 to­taled $380 mil­lion for Gilead, as the com­pa­ny said it saw con­tin­ued up­take for the ap­proved treat­ment in sec­ond-line metasta­t­ic triple-neg­a­tive breast can­cer in the US and Eu­rope, as well as sec­ond-line metasta­t­ic urothe­lial can­cer in the US.

Sales have since surged high­er in 2022, which is wel­come news for the com­pa­ny af­ter Gilead took a $2.7 bil­lion write­down last quar­ter for Trodelvy on the heels of an­oth­er vague piv­otal read­out.

The phar­ma com­pa­ny drew harsh re­views from an­a­lysts back in March when it re­vealed that Trodelvy met its pri­ma­ry end­point of pro­gres­sion-free sur­vival in late-line metasta­t­ic HR+/HER2- breast can­cer, but didn’t share the hard da­ta.