A ranar 30 ga Yuni, 2025, HUTCHMED ta sanar da cewa Hukumar Kayayyakin Lafiya ta Kasa ta kasar Sin (NMPA) ta amince da amfani da Sabon Maganin Magani (NDA) don hadewar ORPATHYS (savolitinib) da TAGRISSO (osimertinib) don maganin marasa lafiya da ke fama da cutar kansar huhu ta hanji (EGFR) mai saurin kamuwa da cutar sankarar huhu (NSCLC) bayan ci gaban cutar a maganin EGFR tyrosine kinase inhibitor (TKI). ORPATHYS magani ne na baki, mai karfi kuma mai zabi sosai. TAGRISSO magani ne na EGFR TKI na ƙarni na uku, wanda ba za a iya canzawa ba.
ORPATHYS ita ce farkon mai hana MET da aka amince da shi a China, wanda aka nuna wa manya marasa lafiya da ke fama da cutar NSCLC mai saurin yaduwa ko kuma ta hanyar maye gurbin MET exon 14. Wannan sabon amincewa daga NMPA ya dogara ne akan bayanai daga gwajin SACHI Phase III na haɗin ORPATHYS da TAGRISSO (NCT05015608), bayan sun cimma matsayar farko ta rayuwa ba tare da ci gaba ba (PFS) da aka riga aka ayyana a cikin wani bincike na wucin gadi da aka tsara. An gabatar da manyan sakamakon a taron shekara-shekara na American Society of Clinical Oncology (ASCO) a watan Yunin 2025.
Ya zuwa ƙarshen bayanan bincike na wucin gadi na ranar 30 ga Agusta, 2024, an yi wa jimillar marasa lafiya 211 gwaji don karɓar haɗin savolitinib da osimertinib ko chemotherapy. A cikin niyyar magance yawan jama'a (ITT), matsakaicin rayuwa ba tare da ci gaba ba (PFS) wanda mai bincike ya tantance shine watanni 8.2 tare da savolitinib da osimertinib, idan aka kwatanta da watanni 4.5 tare da chemotherapy. Kwamitin bita mai zaman kansa (IRC) ya tantance matsakaicin PFS shine watanni 7.2 idan aka kwatanta da watanni 4.2, bi da bi.
Adadin amsawar da mai binciken ya kimanta (ORR) ya kai kashi 58% a cikin rukunin savolitinib da osimertinib idan aka kwatanta da kashi 34% ga marasa lafiya a cikin rukunin chemotherapy. Matsakaicin lokacin da aka auna cutar (DCR) ya kai kashi 89% idan aka kwatanta da kashi 67% kuma matsakaicin tsawon lokacin da aka auna (DoR) ya kai watanni 8.4 idan aka kwatanta da watanni 3.2. Jimillar rayuwa ba ta kai ba a lokacin nazarin wucin gadi.
Sakamakon inganci a cikin marasa lafiya da aka yi wa magani da maganin hana tyrosine kinase na EGFR (TKI) na ƙarni na uku ya yi daidai da waɗanda ke cikin mutanen da aka yi wa magani da kuma waɗanda aka yi wa magani da EGFR-TKI na ƙarni na uku. A cikin ƙungiyar da aka yi wa magani da EGFR-TKI na ƙarni na uku, matsakaicin PFS da aka yi wa bincike da kuma waɗanda aka yi wa kimantawa da IRC sun kasance daidai, duka a watanni 6.9 da 3.0.
An jure yanayin aminci na haɗin savolitinib da osimertinib kuma ba a ga sabbin alamun aminci ba. Abubuwan da suka faru na rashin lafiya na aji na 3 ko sama da haka sun faru a cikin kashi 57% na marasa lafiya a cikin rukunin savolitinib da osimertinib idan aka kwatanta da kashi 57% ga marasa lafiya a cikin rukunin chemotherapy, wanda ke nuna kyakkyawan yanayin aminci.
Game da ORPATHYS
ORPATHYS (savolitinib) magani ne na baki, mai ƙarfi kuma mai zaɓe sosai wanda ya nuna aikin asibiti a cikin ciwace-ciwacen da suka ci gaba. Yana toshe kunna hanyar tyrosine kinase mai karɓar MET wanda ba a saba gani ba wanda ke faruwa saboda maye gurbi (kamar canje-canjen tsallakewa na exon 14 ko wasu maye gurbi na maki), haɓaka kwayoyin halitta ko yawan furotin.®
Game da TAGRISSO®
TAGRISSO (osimertinib) wani nau'in EGFR-TKI ne na ƙarni na uku, wanda ba za a iya jurewa ba, wanda ke da ingantaccen aiki a asibiti a cikin NSCLC, gami da kamuwa da cutar ta tsakiya (CNS). An yi amfani da TAGRISSO (kwayoyi 40mg da 80mg sau ɗaya a rana) don magance kusan marasa lafiya 800,000 a duk faɗin duniya kuma AstraZeneca ta ci gaba da bincika TAGRISSO a matsayin magani ga marasa lafiya a matakai daban-daban na EGFRm NSCLC.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Yuli-03-2025