Uvavanyo luqala kwi-Monotherapy yokuKhetha okuPhezulu okanye kwe-Metastatic Solid Tumors

I-Jazz Pharmaceuticals plc namhlanje ibhengeze isigulana sokuqala esibhaliswe kwi-EMERGE-201, iSigaba se-2 solingo lwezonyango oluvavanya ukhuseleko kunye nokusebenza kakuhle kwe-Zepzelca® (lurbinectedin) njenge-monotherapy kumaqela amathathu ezigulane ezine-urothelial carcinoma, i-cell cell neuroendocrine carcinoma imiphunga, okanye i-homologous recombination deficient (HRD) amathumba athe aqhubela phambili kwirejimeni eneplatinam. I-EMERGE-201 iya kuvavanya ngokuyinhloko imilinganiselo yokuphendula injongo yesigulane (ORR), ngokweNqanaba lokuHlola iMpendulo kwiiTumors eziqinileyo (RECIST).

"Nangona ukuqhubela phambili ngokukhawuleza kwitekhnoloji yezonyango kunye nokuhanjiswa kokhathalelo kuzo zonke iintlobo zethumba kule minyaka ilishumi idlulileyo, kusekho izigulana ezininzi eziqhubeka nokujongana neemfuno ezingafezekiyo kwaye zifumana umthwalo omkhulu wokugula nokufa," utshilo uArielle Heeke, MD, ibele. I-oncologist yezokwelapha kwi-Levine Cancer Institute kunye nomphandi oyintloko kwilingo le-EMERGE-201. “Ngolingo lwe-EMERGE-201 oluqhubayo ngoku, sijonge phambili ekuboneni impembelelo yezonyango enokubakho yeZepzelca kumhlaza wethumba eliqinileyo, kubandakanya nomhlaza we-HRD, ezinokhetho olumiselweyo lonyango olungaphandle kwechemotherapy yesintu. Ulingo luza kuvavanya ukuba olu nyango lunokubangela impendulo yethumba esekwe kwibhayoloji esisiseko yezi zomhlaza kunye nendlela yenoveli yeZepzelca. ”

“Olu kuqaliswa kovavanyo sisiganeko esonwabisayo kwinkqubo yophuhliso lwezonyango lweZepzelca, njengoko sifuna ukuvavanya ukusebenza kwayo kwezonyango ngaphaya kokunyanga umhlaza wemiphunga omncinci weseli,” utshilo uRob Iannone, MD, MSCE, usekela mongameli welizwe, intloko yophando kunye nophuhliso lweJazz. Amachiza. "Ngenxa yokuba iZepzelca ibangela i-cascade yeziganeko ezinokuchaphazela umsebenzi we-DNA ebopha iiprotheyini - kubandakanywa izinto ezibhaliweyo kunye neendlela zokulungisa i-DNA - sijonge phambili ekuhlalutyeni umsebenzi we-Zepzelca kunyango olongezelelweyo olunzima lokunyanga umhlaza apho i-oncogenes yomqhubi ibhalwa ngenkuthalo kunye nokulungiswa kwe-DNA. iindlela azisebenzi kakuhle, ezifana ne-urothelial carcinoma, iseli enkulu ye-neuroendocrine carcinoma yomphunga kunye namathumba ane-HRD-positive.”

Iinkcukacha zovavanyo lwe-EMERGE-201

I-EMERGE-201 iSigaba se-2, i-multicenter, i-open-label trial eyenzelwe ukuhlola ukhuseleko kunye nokusebenza kakuhle kwe-Zepzelca njenge-monotherapy kumaqela amathathu ezigulane ezineethumba eziqinileyo, eziza kufumana i-3.2 mg / m2 idosi ye-Zepzelca nge-intravenously ngosuku lokuqala umjikelo wedosi yeeveki ezintathu, de kuqinisekiswe ukuqhubeka kwesifo. Amaqela mathathu ngala: izigulane ezine-urothelial carcinoma, iseli enkulu ye-neuroendocrine carcinoma yomphunga, okanye amathumba e-HRD athe aqhubela phambili kwirejimeni eneplatinam.

Injongo ephambili kukumisela amandla kaZepzelca okuphucula iziphumo zesigulane, njengoko kulinganiswe yi-ORR. Iziphelo eziphambili zesekondari ziquka ukuqhubela phambili komphandi-ukuhlolwa kwamahhala, ixesha lokuphendula, ixesha lokuphendula, kunye nezinga lokulawula izifo njengoko kuhlolwe yi-RECIST, kunye nokusinda ngokubanzi kubathathi-nxaxheba abaphathwa ngeZepzelca. Eli lingo lixhaswa ngemali kwaye liqhutywa yiJazz Pharmaceuticals.

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