Imvume yaseTshayina ye-ORPATHYS ngokudityaniswa neTAGRISSO yoNyango lweZigulana zoMhlaza weMiphunga ezine-MET Amplification Emva kokuqhubela phambili kwi-First-Line EGFR Inhibitor Therapy

Ngomhla wama-30 kweyeSilimela, ngo-2025, iHUTCHMED ibhengeza ukuba iSicelo seMithi emiTsha (NDA) sokudityaniswa kwe-ORPATHYS (savolitinib) kunye ne-TAGRISSO (osimertinib) sivunyiwe yi-China National Medical Products Administration (NMPA) yokunyanga izigulane ezine-local advanced okanye metastatic epidermal growth factor receptor (EGFR) mutation-positive non-squamous non-small cell lung cancer (NSCLC) nge-MET amplification emva kokuqhubela phambili kwesifo kwi-EGFR tyrosine kinase inhibitor (TKI). I-ORPATHYS yi-MET TKI yomlomo, enamandla kwaye ikhetha kakhulu. I-TAGRISSO yi-EGFR TKI yesizukulwana sesithathu, engenakuguqulwa.

I-ORPATHYS yayiyeyona inhibitor yokuqala ye-MET ekhethiweyo eyamkelweyo eTshayina, eboniswe kwizigulane zabantu abadala abane-NSCLC ephucukileyo okanye eguqukileyo ene-MET exon 14 skipping alteration. Olu vunyiweyo lutsha yi-NMPA lwalusekelwe kwidatha evela kuvavanyo lwe-SACHI Phase III lwe-ORPATHYS kunye ne-TAGRISSO indibaniselwano (NCT05015608), emva kokuba ifikelele kwisiphelo esichazwe kwangaphambili se-primary endpoint of progression-free survival (PFS) kuhlalutyo lwexeshana olucwangcisiweyo kwangaphambili. Iziphumo eziphambili zavezwa kwiNtlanganiso yoNyaka ye-American Society of Clinical Oncology (ASCO) ngoJuni 2025.

Ukusukela kwisiphelo sedatha yohlalutyo lwexeshana nge-30 ka-Agasti 2024, izigulane ezingama-211 zizonke zathathwa ngokungacwangciswanga ukuze zifumane i-savolitinib kunye ne-osimertinib indibaniselwano okanye i-chemotherapy. Ngenjongo yokunyanga (ITT), i-median progression-free survival (PFS) ehlolwe ngumphandi yayiziinyanga eziyi-8.2 nge-savolitinib kunye ne-osimertinib, xa kuthelekiswa neenyanga eziyi-4.5 nge-chemotherapy. Ikomiti yophononongo ezimeleyo (IRC) ivavanye i-median PFS yayiziinyanga eziyi-7.2 xa kuthelekiswa neenyanga eziyi-4.2, ngokwahlukeneyo.

Izinga lokuphendula elijolise ngqo (ORR) elivavanywe ngumphengululi lalingama-58% kwiqela le-savolitinib kunye ne-osimertinib xa lithelekiswa nama-34% kwizigulane ezikwiqela le-chemotherapy. Izinga lokulawula isifo (DCR) lalingama-89% xa kuthelekiswa nama-67% kwaye ubude bexesha eliphakathi lokuphendula (DoR) lalingama-8.4 iinyanga xa kuthelekiswa neenyanga ezi-3.2, ngokwahlukeneyo. Ukusinda ngokubanzi bekungavuthwanga ngexesha lohlalutyo lwexeshana.

Iziphumo zokusebenza kakuhle kwizigulane ezinyangwe yi-EGFR tyrosine kinase inhibitor (TKI) zesizukulwana sesithathu zazifana nezo zikwiqela labantu abanomdla wokunyanga kunye nesizukulwana sesithathu abangenalwazi. Kwiqela elincinci lesizukulwana sesithathu elinyangwe yi-EGFR-TKI, i-PFS ephakathi evavanyiweyo ngumphandi kunye ne-IRC yayihambelana kakhulu, zombini kwiinyanga eziyi-6.9 xa kuthelekiswa ne-3.0.

Iprofayili yokhuseleko lwendibaniselwano ye-savolitinib kunye ne-osimertinib yayinyamezeleka kwaye akukho zimpawu zintsha zokhuseleko eziboniweyo. Iziganeko ezimbi ezivele ngonyango zeBanga lesi-3 okanye ngaphezulu zenzeke kwi-57% yezigulane kwiqela le-savolitinib kunye ne-osimertinib xa kuthelekiswa ne-57% kwizigulane ezikwiqela le-chemotherapy, nto leyo ebonisa ukuba iprofayili yokhuseleko ilungile.

Malunga ne-ORPATHYS

I-ORPATHYS (savolitinib) yi-MET TKI yomlomo, enamandla kwaye ikhetha kakhulu ebonakalise umsebenzi weklinikhi kwiithumba eziqinileyo eziphambili. Ithintela ukusebenza okungaqhelekanga kwendlela ye-MET receptor tyrosine kinase eyenzeka ngenxa yenguqu (ezifana notshintsho lwe-exon 14 skipping okanye ezinye iinguqulelo zenqaku), ukwandiswa kwezakhi zofuzo okanye ukubonakaliswa kweproteni kakhulu.®

Malunga neTAGRISSO®

I-TAGRISSO (osimertinib) sisizukulwana sesithathu, esingaguqukiyo se-EGFR-TKI esinomsebenzi weklinikhi oqinisekisiweyo kwi-NSCLC, kuquka nxamnye ne-metastases yenkqubo ye-nervous system (CNS). I-TAGRISSO (40mg kunye ne-80mg iipilisi zomlomo ezithathwa kanye ngemini) isetyenziselwe ukunyanga phantse izigulane ezingama-800,000 kuzo zonke iimpawu zayo kwihlabathi liphela kwaye i-AstraZeneca iyaqhubeka nokuphonononga i-TAGRISSO njengonyango lwezigulane kuzo zonke izigaba ezahlukeneyo ze-EGFRm NSCLC.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

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