Ma Iune 30, 2025, hoʻolaha ʻo HUTCHMED ua ʻae ʻia ka New Drug Application (NDA) no ka hui pū ʻana o ORPATHYS (savolitinib) a me TAGRISSO (osimertinib) e ka China National Medical Products Administration (NMPA) no ka mālama ʻana i nā maʻi me ka locally advanced a i ʻole metastatic epidermal growth factor receptor (EGFR) mutation-positive non-squamous non-small cell lung cancer (NSCLC) me ka MET amplification ma hope o ka holomua ʻana o ka maʻi ma ka lāʻau lapaʻau EGFR tyrosine kinase inhibitor (TKI). He MET TKI waha, ikaika a koho nui ʻo ORPATHYS. He EGFR TKI hanauna ʻekolu ʻo TAGRISSO, hiki ʻole ke hoʻihoʻi ʻia.
ʻO ORPATHYS ka mea hoʻopaʻa MET koho mua i ʻae ʻia ma Kina, i hōʻike ʻia no nā poʻe maʻi makua me ka NSCLC holomua kūloko a metastatic paha me ka MET exon 14 skipping alteration. Ua hoʻokumu ʻia kēia ʻae hou e ka NMPA ma ka ʻikepili mai ka hoʻokolohua SACHI Phase III o ka hui pū ʻana o ORPATHYS a me TAGRISSO (NCT05015608), ua hālāwai me ke kiko mua i wehewehe mua ʻia o ke ola ʻole holomua (PFS) i loko o kahi loiloi waena i hoʻolālā mua ʻia. Ua hōʻike ʻia nā hopena mua ma ka Hālāwai Makahiki ʻo American Society of Clinical Oncology (ASCO) i Iune 2025.
E like me ka ʻoki ʻikepili loiloi waena o ʻAukake 30, 2024, ua koho ʻia he 211 mau maʻi e loaʻa i ka hui pū ʻana o savolitinib a me osimertinib a i ʻole chemotherapy. I ka heluna kanaka manaʻo e mālama (ITT), ʻo ka awelika o ke ola ʻole o ka holomua (PFS) i loiloi ʻia e ka mea noiʻi he 8.2 mau mahina me savolitinib me osimertinib, i hoʻohālikelike ʻia me 4.5 mau mahina me ka chemotherapy. Ua loiloi ke kōmike loiloi kūʻokoʻa (IRC) i ka awelika o ka PFS he 7.2 mau mahina vs 4.2 mau mahina, kēlā me kēia.
ʻO ka helu pane pahuhopu (ORR) i loiloi ʻia e ka mea noiʻi he 58% i ka hui savolitinib me osimertinib i hoʻohālikelike ʻia me 34% no nā maʻi i ka hui chemotherapy. ʻO ka helu kaohi maʻi (DCR) he 89% vs 67% a ʻo ka lōʻihi waena o ka pane (DoR) he 8.4 mau mahina vs 3.2 mau mahina, kēlā me kēia. ʻAʻole i oʻo ka ola holoʻokoʻa i ka manawa o ka loiloi waena.
Ua like nā hopena kūpono i nā poʻe maʻi i mālama ʻia me ka EGFR tyrosine kinase inhibitor (TKI) o ke kolu o ka hanauna me nā poʻe i loko o ka poʻe i manaʻo ʻia e mālama a me nā poʻe i mālama ʻole ʻia no ka EGFR-TKI o ke kolu o ka hanauna. I loko o ka hui liʻiliʻi o ka hanauna ʻekolu i mālama ʻia me ka EGFR-TKI, ua kūlike loa ka PFS waena i loiloi ʻia e ka mea noiʻi a me ka IRC i loiloi ʻia, ma 6.9 vs 3.0 mau mahina.
Ua ʻae ʻia ke ʻano palekana o ka hui pū ʻana o savolitinib a me osimertinib a ʻaʻohe hōʻailona palekana hou i ʻike ʻia. Ua ʻike ʻia nā hanana ʻino i hoʻomaka ʻia mai ka lāʻau lapaʻau o ka Papa 3 a i ʻole ma luna i 57% o nā maʻi ma ka hui savolitinib me osimertinib i hoʻohālikelike ʻia me 57% no nā maʻi ma ka hui chemotherapy, e hōʻike ana i kahi ʻano palekana maikaʻi.
E pili ana i nā ORPATHYS
ʻO ORPATHYS (savolitinib) kahi MET TKI waha, ikaika a koho nui ʻia i hōʻike i ka hana lapaʻau i nā ʻōpū paʻa holomua. Hoʻopaʻa ia i ka hoʻāla ʻana atypical o ke ala receptor MET tyrosine kinase e kū mai ana ma muli o nā mutations (e like me ka exon 14 skipping alterations a i ʻole nā point mutations ʻē aʻe), ka hoʻonui ʻana o ka gene a i ʻole ka overexpression protein.®
E pili ana iā TAGRISSO®
ʻO TAGRISSO (osimertinib) kahi hanauna ʻekolu, ʻaʻole hiki ke hoʻihoʻi ʻia EGFR-TKI me ka hana lapaʻau i hōʻoia ʻia ma NSCLC, me ke kūʻē ʻana i nā metastases o ka ʻōnaehana nerve waena (CNS). Ua hoʻohana ʻia ʻo TAGRISSO (40mg a me 80mg papa waha hoʻokahi i ka lā) e mālama i kahi kokoke i 800,000 mau maʻi ma kāna mau hōʻailona ma ka honua holoʻokoʻa a ke hoʻomau nei ʻo AstraZeneca i ka ʻimi ʻana iā TAGRISSO ma ke ʻano he lāʻau lapaʻau no nā maʻi ma nā pae he nui o EGFRm NSCLC.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Ka manawa hoʻouna: Iulai-03-2025