I-Jazz Pharmaceuticals plc namuhla imemezele ukuthi isiguli sokuqala sibhalisele i-EMERGE-201, isivivinyo somtholampilo seSigaba 2 esihlola ukuphepha nokusebenza ngempumelelo kwe-Zepzelca® (lurbinectedin) njenge-monotherapy emaqenjini amathathu eziguli ezine-urothelial carcinoma, i-cell neuroendocrine carcinoma enkulu amaphaphu, noma amathumba e-homologous recombination deficient (HRD) aqhubekele phambili ohlelweni oluqukethe iplatinamu. I-EMERGE-201 izohlola ngokuyinhloko izilinganiso zokuphendula kwenhloso yesiguli (ORR), ngokuya Ngemibandela Yokuhlola Ukusabela Kumathumba Aqinile (RECIST).
"Ngisho nokuthuthuka okusheshayo kwezobuchwepheshe bezokwelapha kanye nokulethwa kokunakekelwa kuzo zonke izinhlobo eziningi zesimila kule minyaka eyishumi edlule, kuseneziguli eziningi eziqhubeka nokubhekana nezidingo ezingafinyeleleki futhi zithola umthwalo omkhulu wokugula nokufa," kusho u-Arielle Heeke, MD, ibele. i-oncologist yezokwelapha e-Levine Cancer Institute kanye nomphenyi oyinhloko ocwaningweni lwe-EMERGE-201. “Njengoba kuqhubeka uvivinyo lwe-EMERGE-201 manje, sibheke ngabomvu ukubona umthelela womtholampilo ongaba khona we-Zepzelca kumdlavuza oqinile wesimila esiqinile, okuhlanganisa nomdlavuza we-HRD, anezinketho zokwelashwa ezivunyelwe ezilinganiselwe ngaphandle kwe-chemotherapy yendabuko. Icala lizohlola ukuthi ingabe lokhu kwelashwa kungathola impendulo yesimila ngokususelwa kusisekelo sebhayoloji yale midlavuza kanye nendlela yenoveli kaZepzelca yokwenza.”
"Lokhu kuqaliswa kwesivivinyo kuyingqopha-mlando ethokozisayo yohlelo lokuthuthukiswa komtholampilo lweZepzelca, njengoba sifuna ukuhlola ukusebenza kwayo emtholampilo ngaphandle kokwelapha umdlavuza wamaphaphu omncane," kusho uRob Iannone, MD, MSCE, iphini likamongameli omkhulu, inhloko yomhlaba wonke yocwaningo nokuthuthukiswa kweJazz. Ezemithi. "Njengoba i-Zepzelca iqala uchungechunge lwezenzakalo ezingathinta umsebenzi wamaprotheni abopha i-DNA - okuhlanganisa izici ezibhalwe phansi kanye nezindlela zokulungisa i-DNA - sibheke ngabomvu ukuhlaziya umsebenzi we-Zepzelca kweminye imidlavuza enzima ukwelapha lapho ama-oncogenes omshayeli ebhalwa ngenkuthalo kanye nokulungiswa kwe-DNA. Izindlela azisebenzi kahle, njenge-urothelial carcinoma, i-cell neuroendocrine carcinoma yamaphaphu kanye nezimila ezine-HRD-positive."
Imininingwane Yesivivinyo Ye-EMERGE-201
I-EMERGE-201 iyisivivinyo seSigaba 2, esimaphakathi, esinelebula evulekile eklanyelwe ukuhlola ukuphepha nokusebenza kwe-Zepzelca njenge-monotherapy emaqenjini amathathu eziguli ezinamathumba aqinile, ezizothola imithamo engu-3.2 mg/m2 ye-Zepzelca ngomthambo ngosuku lokuqala lwenyanga. umjikelezo womthamo wamasonto amathathu, kuze kube yilapho kuqinisekisiwe ukuqhubeka kwesifo. Amaqoqo amathathu yilawa: iziguli ezine-urothelial carcinoma ethuthukisiwe, i-cell neuroendocrine carcinoma enkulu yamaphaphu, noma izimila ze-HRD eziqhubekele phambili ohlelweni oluqukethe i-platinum.
Inhloso eyinhloko ukucacisa ikhono le-Zepzelca lokuthuthukisa imiphumela yesiguli, njengoba kulinganiswa nge-ORR. Iziphetho eziyisihluthulelo zesibili zihlanganisa ukusinda kwamahhala kokuqhubekela phambili okuhlolwe umphenyi, isikhathi sokuphendula, ubude besikhathi sokuphendula, kanye nezinga lokulawula izifo njengoba lihlolwe yi-RECIST, kanye nokusinda okuphelele kubahlanganyeli abaphathwa nge-Zepzelca. Leli cala lixhaswe futhi liqhutshwa yiJazz Pharmaceuticals.
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