I bhFeabhrary 2023, d'fhormheas an Riarachán Bia agus Drugaí (FDA) elacestrant (Orserdu, Stemline Therapeutics, Inc.) do mhná nó d'fhir os cionn 50 a bhfuil ailse chíche chun cinn nó metastatach acu agus atá ER-dearfach, HER2-diúltach, agus a bhfuil sócháin ESR1 acu. Tá an galar tar éis dul chun cinn tar éis líne amháin de theiripe endocrine ar a laghad.
Tugadh faomhadh FDA freisin do mheasúnacht CDx Guardant360 mar uirlis dhiagnóiseach chompánach le haghaidh cóireáil elacestrant ar othair a bhfuil ailse chíche orthu.
EMERALD (NCT03778931), a randomised, open-label, active-controlled, multicenter trial that included 478 postmenopausal women and men with advanced or metastatic ailse chíche in whom 228 patients had ESR1 mutations, investigated the effectiveness of the treatment. Patients had to have seen disease progression after receiving one or more lines of endocrine therapy in the past, including at least one line that contained a CDK4/6 inhibitor. Patients who were eligible could have had up to one prior line of chemotherapy for advanced or metastatic disease. Elacestrant 345 mg orally once daily was given to patients who were randomly assigned (1:1) to receive it or investigator’s choice of endocrine therapy, which included fulvestrant (n=166) or an aromatase inhibitor (n=73). ESR1 mutation status (found vs. not found), previous fulvestrant treatment (yes vs. no), and visceral metastasis were used to divide the patients into groups for randomization (yes vs. no). The Guardant360 CDx assay was used to identify ESR1 missense mutations in the ligand binding domain and was limited to blood circulating tumour deoxyribonucleic acid (ctDNA).
Ba é an príomhbheart toraidh éifeachtúlachta ná maireachtáil saor ó dhul chun cinn (PFS), a ndearna coiste athbhreithnithe íomháithe dalláilte meastóireacht air. Sa daonra le ITT agus i bhfoghrúpa na n-othar le sócháin ESR1, bhí difríocht shuntasach staitistiúil i PFS.
Ba é an PFS airmheánach ná 3.8 mí (95% CI: 2.2, 7.3) do na hothair 228 (48%) le sócháin ESR1 a ndearnadh cóireáil orthu le elacestrant agus 1.9 mí (95% CI: 1.9, 2.1) dóibh siúd ar cuireadh cóireáil orthu le fulvestrant nó le cosc aromatase. (cóimheas guaise [HR] de 0.55 [95% CI: 0.39, 0.77], p-luach dhá thaobh = 2).
Bhí HR de 250 (52% CI: 1, 0.86) ag na hothair 95 (0.63%) gan sócháin ESR1.19 san anailís taiscéalaíoch ar PFS, rud a léirigh go raibh na torthaí a chonacthas i ndaonra mutant ESR1 freagrach go príomha as feabhas a chur ar an gcohórt ITT. .
Pian mhatánchnámharlaigh, nausea, colaistéaról ardaithe, AST ardaithe, tríghlicrídí ardaithe, tuirse, haemaglóibin laghdaithe, urlacan, ALT ardaithe, sóidiam ardaithe, creatinine ardaithe, laghdaigh goile, buinneach, tinneas cinn, constipation, pian bhoilg, sruthlú te, agus an chuid is mó dyspepsia. teagmhais dhíobhálacha go minic (10%), lena n-áirítear neamhghnáchaíochtaí saotharlainne.
Moltar 345 mg de elacestrant a ghlacadh uair amháin sa lá le bia go dtí go dtéann an galar chun cinn nó go dtiocfaidh an tocsaineacht do-ghlactha.
View full prescribing information for Orserdu.
