Musi wa30 Chikumi, 2025, HUTCHMED yakazivisa kuti New Drug Application (NDA) yekusanganisa ORPATHYS (savolitinib) neTAGRISSO (osimertinib) yabvumidzwa neChina National Medical Products Administration (NMPA) yekurapa varwere vane chirwere chekenza yemapapu chemuno (NSCLC) mutation-positive non-squamous non-small cell lung cancer (NSCLC) ine MET amplification mushure mekukura kwechirwere paEGFR tyrosine kinase inhibitor (TKI) therapy. ORPATHYS iMET TKI inonwiwa nemuromo, ine simba uye inosarudza zvakanyanya. TAGRISSO iEGFR TKI yechizvarwa chechitatu, isingadzoreki.
ORPATHYS ndiyo yekutanga mushonga weMET inhibitor wakatenderwa muChina, wakaitirwa varwere vakuru vane NSCLC yepamusoro kana kuti yakapararira munzvimbo ine MET exon 14 skipping alteration. Kubvumidzwa uku kutsva neNMPA kwakavakirwa padata kubva muongororo yeSACHI Phase III yeORPATHYS neTAGRISSO combination (NCT05015608), mushure mekusangana nepfungwa yekutanga yehupenyu husina kufambiswa mberi (PFS) muongororo yenguva pfupi yakarongwa. Mhedzisiro yekutanga yakapihwa paMusangano weGore weAmerican Society of Clinical Oncology (ASCO) muna Chikumi 2025.
Pakupera kwedata rekuongorora kwakaitwa musi wa30 Nyamavhuvhu, 2024, varwere vanosvika mazana maviri negumi nerimwe vakanyoreswa kuti vagamuchire mushonga we savolitinib ne osimertinib kana chemotherapy. Muchirongwa chekurapa (ITT), huwandu hwevanhu vanorarama vasingapfuuri (PFS) hwakaongororwa nemuongorori hwaive mwedzi 8.2 ne savolitinib pamwe ne osimertinib, zvichienzaniswa nemwedzi 4.5 ne chemotherapy. Komiti yekuongorora yakazvimirira (IRC) yakaongorora kuti PFS yepakati yaive mwedzi 7.2 vs mwedzi 4.2, zvichiteerana.
Muongorori-assessed objective response rate (ORR) yaive 58% muboka resavolitinib pamwe neosimertinib zvichienzaniswa ne34% yevarwere vari muboka rechemotherapy. Muyero wekutonga chirwere (DCR) waiva 89% uchienzaniswa ne67% uye nguva yepakati yekupindura (DoR) yaive mwedzi 8.4 uchienzaniswa nemwedzi 3.2, zvichiteerana. Kurarama kwese kwakanga kusati kwakura panguva yekuongorora kwenguva pfupi.
Kushanda zvakanaka kwevarwere vakarapwa neEGFR tyrosine kinase inhibitor (TKI) yechizvarwa chechitatu kwakafanana neavo vari mumapoka eEGFR-TKI asina ruzivo uye echizvarwa chechitatu asina ruzivo. Muboka rechitatu reEGFR-TKI rakarapwa, PFS yepakati yakaongororwa nevaongorori uye IRC-yakaongororwa yaienderana zvakanyanya, ese ari maviri ari pa6.9 vs 3.0 mwedzi.
Kuchengetedzwa kwemusanganiswa we savolitinib ne osimertinib kwaikwanisika uye hapana zviratidzo zvitsva zvekuchengetedza zvakaonekwa. Zviitiko zvakaipa zvekurapa-zvichibuda zveGiredhi 3 kana kupfuura zvakaitika mu57% yevarwere vari muboka re savolitinib pamwe ne osimertinib zvichienzaniswa ne57% yevarwere vari muboka re chemotherapy, zvichiratidza kuchengetedzeka kwakanaka.
Nezve ORPATHYS
ORPATHYS (savolitinib) mushonga weMET TKI unonwiwa nemuromo, une simba uye unosarudza zvakanyanya uye wakaratidza kushanda kwekiriniki muzvirwere zvakasimba. Unovhara kushanda kusingawanzoitiki kwenzira yeMET receptor tyrosine kinase inoitika nekuda kwekuchinja (senge exon 14 skipping alterations kana mamwe ma point mutations), kuwedzera kwemajini kana kuwedzera kwemapuroteni.®
Nezve TAGRISSO®
TAGRISSO (osimertinib) ichizvarwa chechitatu, chisingadzoreki EGFR-TKI ine basa rekurapa rakaonekwa muNSCLC, kusanganisira kurwisa metastases yepakati petsinga (CNS). TAGRISSO (40mg uye 80mg mapiritsi anonwiwa kamwe chete pazuva) yakashandiswa kurapa varwere vanosvika 800,000 zvichienderana nezviratidzo zvayo pasi rese uye AstraZeneca inoramba ichiongorora TAGRISSO senzira yekurapa varwere vari mumatanho akasiyana-siyana eEGFRm NSCLC.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Nguva yekutumira: Chikunguru-03-2025