Thaum Lub Rau Hli 30, 2025, HUTCHMED tshaj tawm tias Daim Ntawv Thov Tshuaj Tshiab (NDA) rau kev sib xyaw ua ke ntawm ORPATHYS (savolitinib) thiab TAGRISSO (osimertinib) tau txais kev pom zoo los ntawm Tuam Tshoj National Medical Products Administration (NMPA) rau kev kho mob ntawm cov neeg mob uas muaj mob qog nqaij hlav hauv zos lossis metastatic epidermal growth factor receptor (EGFR) mutation-positive non-squamous non-small cell lung cancer (NSCLC) nrog MET amplification tom qab kev mob nkeeg ntawm EGFR tyrosine kinase inhibitor (TKI) kev kho mob. ORPATHYS yog qhov ncauj, muaj zog thiab xaiv tau zoo MET TKI. TAGRISSO yog tiam peb, tsis tuaj yeem rov qab tau EGFR TKI.
ORPATHYS yog thawj qhov kev xaiv MET inhibitor uas tau pom zoo hauv Suav teb, qhia rau cov neeg mob laus uas muaj NSCLC hauv zos lossis metastatic nrog MET exon 14 hla kev hloov pauv. Qhov kev pom zoo tshiab no los ntawm NMPA yog raws li cov ntaub ntawv los ntawm SACHI Theem III kev sim ntawm ORPATHYS thiab TAGRISSO ua ke (NCT05015608), tau ntsib qhov kawg tseem ceeb uas tau txhais ua ntej ntawm kev ciaj sia tsis muaj kev nce qib (PFS) hauv kev tshuaj xyuas ib ntus uas tau npaj ua ntej. Cov txiaj ntsig tseem ceeb tau nthuav tawm ntawm American Society of Clinical Oncology (ASCO) Lub Rooj Sib Tham Txhua Xyoo thaum Lub Rau Hli 2025.
Raws li qhov kawg ntawm cov ntaub ntawv tshuaj xyuas ib ntus ntawm lub Yim Hli 30, 2024, tag nrho ntawm 211 tus neeg mob tau raug xaiv los txais kev sib xyaw ua ke ntawm savolitinib thiab osimertinib lossis chemotherapy. Hauv cov pej xeem uas xav kho (ITT), qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib (PFS) uas tus kws tshawb fawb ntsuas yog 8.2 lub hlis nrog savolitinib ntxiv rau osimertinib, piv rau 4.5 lub hlis nrog chemotherapy. Pawg neeg saib xyuas ywj pheej (IRC) tau ntsuas qhov nruab nrab ntawm PFS yog 7.2 lub hlis piv rau 4.2 lub hlis, raws li.
Tus kws tshawb nrhiav tau soj ntsuam qhov feem pua ntawm kev teb rov qab (ORR) yog 58% hauv pawg savolitinib ntxiv rau osimertinib piv rau 34% rau cov neeg mob hauv pawg chemotherapy. Tus nqi tswj kab mob (DCR) yog 89% vs 67% thiab lub sijhawm nruab nrab ntawm kev teb (DoR) yog 8.4 lub hlis vs 3.2 lub hlis, raws li. Tag nrho cov ciaj sia tsis tau loj hlob thaum lub sijhawm ntawm kev tshuaj xyuas ib ntus.
Cov txiaj ntsig zoo ntawm cov neeg mob uas tau kho nrog EGFR tyrosine kinase inhibitor (TKI) tiam thib peb zoo ib yam li cov neeg mob uas tau kho nrog EGFR-TKI tiam thib peb thiab cov neeg uas tsis tau kho nrog EGFR-TKI tiam thib peb. Hauv pawg neeg uas tau kho nrog EGFR-TKI tiam thib peb, qhov nruab nrab ntawm PFS uas tus kws tshawb fawb soj ntsuam thiab IRC soj ntsuam zoo sib xws heev, ob qho tib si ntawm 6.9 vs 3.0 lub hlis.
Cov qauv kev nyab xeeb ntawm kev sib xyaw ua ke ntawm savolitinib thiab osimertinib yog qhov ua tau thiab tsis muaj cov cim qhia kev nyab xeeb tshiab tau pom. Cov xwm txheej tsis zoo ntawm Qib 3 lossis siab dua thaum kho mob tshwm sim hauv 57% ntawm cov neeg mob hauv pawg savolitinib ntxiv rau osimertinib piv rau 57% rau cov neeg mob hauv pawg chemotherapy, qhia txog cov qauv kev nyab xeeb zoo.
Txog ORPATHYS
ORPATHYS (savolitinib) yog ib qho tshuaj MET TKI uas haus, muaj zog thiab xaiv tau zoo heev uas tau ua pov thawj tias muaj kev ua haujlwm hauv kev kho mob hauv cov qog nqaij hlav uas nyuaj kho. Nws thaiv qhov ua haujlwm tsis zoo ntawm txoj kev MET receptor tyrosine kinase uas tshwm sim vim muaj kev hloov pauv (xws li exon 14 hla kev hloov pauv lossis lwm yam kev hloov pauv), kev nthuav dav ntawm cov noob caj noob ces lossis cov protein ntau dhau.®
Txog TAGRISSO®
TAGRISSO (osimertinib) yog tiam thib peb, EGFR-TKI uas tsis rov qab tau nrog kev ua haujlwm pov thawj hauv NSCLC, suav nrog kev tawm tsam lub paj hlwb hauv nruab nrab (CNS) metastases. TAGRISSO (40mg thiab 80mg ib zaug ib hnub ntsiav tshuaj) tau siv los kho yuav luag 800,000 tus neeg mob thoob plaws nws cov cim qhia thoob ntiaj teb thiab AstraZeneca txuas ntxiv tshawb nrhiav TAGRISSO ua kev kho mob rau cov neeg mob thoob plaws ntau theem ntawm EGFRm NSCLC.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Lub Xya Hli-03-2025