I te 30 o Hune, 2025, ka pānuitia e HUTCHMED kua whakaaetia te New Drug Application (NDA) mō te whakakotahitanga o te ORPATHYS (savolitinib) me te TAGRISSO (osimertinib) e te China National Medical Products Administration (NMPA) mō te maimoatanga o ngā tūroro he mate pukupuku pūkahukahu kore-squamous non-small cell lung cancer (NSCLC) kua horapa ki te rohe, kua horapa rānei, me te whakanui MET i muri i te whanaketanga o te mate i runga i te rongoā EGFR tyrosine kinase inhibitor (TKI). Ko te ORPATHYS he MET TKI ā-waha, he kaha, he tino whiriwhiri hoki. Ko te TAGRISSO he EGFR TKI tuatoru o ngā whakatupuranga, kāore e taea te whakakore.
Ko te ORPATHYS te aukati MET whiriwhiri tuatahi i whakaaetia i Haina, i tohua mō ngā tūroro pakeke me te NSCLC kua horapa ki te rohe, kua horapa rānei me te whakarerekētanga o te MET exon 14. I ahu mai tēnei whakaaetanga hou a te NMPA i ngā raraunga mai i te whakamātautau SACHI Phase III o te huinga ORPATHYS me TAGRISSO (NCT05015608), i te mea kua tutuki i a rātou te pito tuatahi kua tautuhia i mua mō te oranga kore-haere whakamua (PFS) i roto i tētahi tātaritanga wā poto kua whakaritea i mua. I whakaaturia ngā hua tuatahi i te Hui-ā-Tau a te American Society of Clinical Oncology (ASCO) i te marama o Hune 2025.
I te mutunga o ngā raraunga tātaritanga wā poto o te 30 o Ākuhata, 2024, i whiriwhiria matapōkeretia te katoa o ngā tūroro 211 kia whiwhi i te huinga savolitinib me te osimertinib, te chemotherapy rānei. I roto i te taupori whakaaro ki te rongoā (ITT), ko te roanga oranga kore-haere-ake (PFS) i aromatawaitia e te kairangahau he 8.2 marama me te savolitinib me te osimertinib, ki te 4.5 marama me te chemotherapy. I aromatawaihia e te komiti arotake motuhake (IRC) te roanga PFS toharite he 7.2 marama ki te 4.2 marama, ia.
Ko te reiti urupare whāinga (ORR) i aromatawaihia e te kairangahau he 58% i roto i te rōpū savolitinib me te osimertinib, ki te whakaritea ki te 34% mō ngā tūroro i roto i te rōpū chemotherapy. Ko te reiti whakahaere mate (DCR) he 89% vs 67%, ā, ko te roanga waenga o te urupare (DoR) he 8.4 marama vs 3.2 marama. Kāore anō kia tino pakari te oranga whānui i te wā o te tātaritanga wā poto.
He rite tonu ngā putanga whai huatanga i roto i ngā tūroro i rongoatia ki te aukati tyrosine kinase EGFR o te whakatupuranga tuatoru ki ērā i roto i ngā taupori kāore anō kia rongoatia me ngā taupori kāore anō kia rongoatia te EGFR-TKI o te whakatupuranga tuatoru. I roto i te rōpū iti i rongoatia ki te EGFR-TKI o te whakatupuranga tuatoru, he tino ōrite te PFS waenga i aromatawaitia e te kairangahau me te IRC, i te 6.9 ki te 3.0 marama.
I taea te whakamanawanui i te āhua haumaru o te huinga savolitinib me te osimertinib, ā, kāore i kitea he tohu haumaru hou. I puta ngā pānga kino o te Taumata 3, neke atu rānei, i te wā e rongoatia ana, i roto i te 57% o ngā tūroro i roto i te rōpū savolitinib me te osimertinib, ki te whakaritea ki te 57% mō ngā tūroro i roto i te rōpū chemotherapy, e tohu ana i te āhua haumaru pai.
Mō ngā mate pukupuku
Ko te ORPHATHYS (savolitinib) he MET TKI ā-waha, kaha, ā, he tino whiriwhiri, kua whakaatu i te kaha haumanu i roto i ngā pukupuku totoka kua matatau. Ka ārai i te whakahohenga rerekē o te ara tyrosine kinase o te kaiwhakawhiwhi MET e puta mai ana i ngā whakarerekētanga (pēnei i te exon 14 skipping changes, i ētahi atu whakarerekētanga pūwāhi rānei), te whakanui ira, te whakanui pūmua rānei.®
Mō TAGRISSO®
Ko te TAGRISSO (osimertinib) he EGFR-TKI o te whakatupuranga tuatoru, kāore e taea te whakakore, kua whakamātauhia te kaha haumanu i roto i te NSCLC, tae atu ki te whawhai ki ngā mate pukupuku o te pūnaha io matua (CNS). Kua whakamahia te TAGRISSO (papa waha 40mg me te 80mg kotahi te wā i te rā) hei rongoā i te tata ki te 800,000 tūroro puta noa i ōna tohu puta noa i te ao, ā, kei te haere tonu a AstraZeneca ki te tūhura i te TAGRISSO hei rongoā mō ngā tūroro puta noa i ngā wāhanga maha o te EGFRm NSCLC.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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Wā tuku: Hōngongoi-03-2025