Ukuvunyelwa kweShayina kwe-ORPATHYS kuhlanganiswe ne-TAGRISSO yokwelapha iziguli zomdlavuza wamaphaphu ezine-MET Amplification Ngemva kokuqhubekela phambili kokwelashwa kwe-EGFR Inhibitor yomugqa wokuqala.

Ngomhlaka-30 Juni 2025, i-HUTCHMED imemezela ukuthi i-New Drug Application (NDA) yokuhlanganiswa kwe-ORPATHYS (savolitinib) kanye ne-TAGRISSO (osimertinib) ivunyelwe yi-China National Medical Products Administration (NMPA) yokwelapha iziguli ezine-local advanced noma metastatic epidermal growth factor receptor (EGFR) mutation-positive non-squamous non-small cell lung cancer (NSCLC) nge-MET amplification ngemuva kokuqhubeka kwesifo ekwelashweni kwe-EGFR tyrosine kinase inhibitor (TKI). I-ORPATHYS iyi-MET TKI yomlomo, enamandla futhi ekhetha kakhulu. I-TAGRISSO iyi-EGFR TKI yesizukulwane sesithathu, engenakuguqulwa.

I-ORPATHYS kwakuyi-inhibitor yokuqala ye-MET ekhethiwe evunyelwe eShayina, ekhonjiswe ezigulini ezindala ezine-NSCLC ethuthukisiwe noma esakazeke endaweni ene-MET exon 14 skipping alteration. Lokhu kuvunyelwa okusha yi-NMPA kwakusekelwe kudatha evela esivivinyweni se-SACHI Phase III se-ORPATHYS kanye nenhlanganisela ye-TAGRISSO (I-NCT05015608), njengoba behlangabezane ne-pre-defined primary endpoint of progressive-free survival (PFS) ekuhlaziyweni kwesikhashana okuhleliwe kusengaphambili. Imiphumela eyinhloko yethulwe eMhlanganweni Waminyaka Yonke we-American Society of Clinical Oncology (ASCO) ngoJuni 2025.

Kusukela ekunqunyweni kwedatha yokuhlaziya okwesikhashana kwangomhlaka-30 Agasti 2024, iziguli ezingu-211 zahlelwa ngokungahleliwe ukuze zithole inhlanganisela ye-savolitinib kanye ne-osimertinib noma i-chemotherapy. Ngenhloso yokwelapha (ITT), ukusinda okuphakathi nendawo okungenalo inqubekela phambili (PFS) okuhlolwe ngumcwaningi kwakuyizinyanga ezingu-8.2 nge-savolitinib kanye ne-osimertinib, uma kuqhathaniswa nezinyanga ezingu-4.5 nge-chemotherapy. Ikomidi elizimele lokubuyekeza (IRC) lihlole i-PFS ephakathi nendawo yayizinyanga ezingu-7.2 uma kuqhathaniswa nezinyanga ezingu-4.2, ngokulandelana.

Izinga lokuphendula elihlosiwe lomcwaningi (ORR) lalingu-58% eqenjini le-savolitinib kanye ne-osimertinib uma kuqhathaniswa no-34% ezigulini eqenjini le-chemotherapy. Izinga lokulawula isifo (DCR) lalingu-89% uma kuqhathaniswa no-67% kanti ubude besikhathi esimaphakathi sempendulo (DoR) babuyizinyanga ezingu-8.4 uma kuqhathaniswa nezinyanga ezingu-3.2, ngokulandelana. Ukusinda sekukonke kwakungavuthiwe ngesikhathi sokuhlaziywa kwesikhashana.

Imiphumela yokusebenza kahle ezigulini eziphathwe nge-EGFR tyrosine kinase inhibitor (TKI) yesizukulwane sesithathu yayifana nalezo ezingabantu abahlose ukwelapha kanye nabantu abangazi lutho nge-EGFR-TKI yesizukulwane sesithathu. Eqenjini elincane lesizukulwane sesithathu elaphethwe yi-EGFR-TKI, i-PFS ephakathi ehlolwe ngumphenyi kanye ne-IRC yayihambisana kakhulu, kokubili ezinyangeni ezingu-6.9 uma kuqhathaniswa nezinyanga ezingu-3.0.

Iphrofayili yokuphepha yenhlanganisela ye-savolitinib ne-osimertinib yayibekezeleleka futhi akukho zimpawu ezintsha zokuphepha ezibonwe. Izehlakalo ezimbi ezivele zokwelashwa zeBanga lesi-3 noma ngaphezulu zenzeka ku-57% weziguli eqenjini le-savolitinib kanye ne-osimertinib uma kuqhathaniswa no-57% weziguli eqenjini le-chemotherapy, okuphakamisa iphrofayili yokuphepha enhle.

Mayelana ne-ORPATHYS

I-ORPATHYS (savolitinib) iyi-MET TKI yomlomo, enamandla futhi ekhetha kakhulu eye yabonisa umsebenzi wezokwelapha ezimila eziqinile ezithuthukile. Ivimba ukusebenza okungajwayelekile kwendlela ye-MET receptor tyrosine kinase eyenzeka ngenxa yokuguqulwa kwezakhi zofuzo (njengokuguqulwa kwe-exon 14 skipping noma ezinye izinguquko zamaphuzu), ukwandiswa kwezakhi zofuzo noma ukuvezwa ngokweqile kwamaprotheni.®

Mayelana ne-TAGRISSO®

I-TAGRISSO (osimertinib) iyisizukulwane sesithathu se-EGFR-TKI, engenakuguqulwa enomsebenzi wezokwelapha oqinisekisiwe ku-NSCLC, okuhlanganisa nokulwa nokuphazamiseka kwesistimu yezinzwa ephakathi (i-CNS). I-TAGRISSO (40mg kanye namaphilisi angu-80mg athathwa kanye ngosuku) isetshenziswe ukwelapha iziguli ezingaba ngu-800,000 kuzo zonke izinkomba zayo emhlabeni jikelele futhi i-AstraZeneca iyaqhubeka nokuhlola i-TAGRISSO njengokwelashwa kweziguli ezigabeni eziningi ze-EGFRm NSCLC.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

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