Kuvomerezedwa kwa China kwa ORPATHYS Kuphatikiza ndi TAGRISSO pochiza Odwala Khansa ya M'mapapo Omwe Ali ndi MET Amplification Pambuyo pa Kupita Patsogolo kwa Chithandizo cha First-Line EGFR Inhibitor

Pa June 30, 2025, HUTCHMED yalengeza kuti New Drug Application (NDA) yogwiritsira ntchito ORPATHYS (savolitinib) ndi TAGRISSO (osimertinib) yavomerezedwa ndi China National Medical Products Administration (NMPA) kuti ichite chithandizo cha odwala omwe ali ndi khansa ya m'mapapo ya m'mapapo ya advanced kapena metastatic epidermal growth factor receptor (EGFR) mutation-positive non-squamous non-small cell lung cancer (NSCLC) yokhala ndi MET amplification pambuyo pa kupita patsogolo kwa matenda pa chithandizo cha EGFR tyrosine kinase inhibitor (TKI). ORPATHYS ndi MET TKI ya pakamwa, yamphamvu komanso yosankha kwambiri. TAGRISSO ndi EGFR TKI ya m'badwo wachitatu, yosasinthika.

ORPATHYS inali mankhwala oyamba oletsa MET osankhidwa ku China, omwe adaperekedwa kwa odwala akuluakulu omwe ali ndi NSCLC yapamwamba kapena yofalikira m'deralo yokhala ndi MET exon 14 skipping alteration. Kuvomerezedwa kwatsopano kumeneku ndi NMPA kudachokera ku deta yochokera ku mayeso a SACHI Phase III a ORPATHYS ndi kuphatikiza kwa TAGRISSO (NCT05015608), atakwaniritsa cholinga choyambirira cha kupulumuka kosapitirira muyeso (PFS) mu kusanthula kwakanthawi komwe kunakonzedwa kale. Zotsatira zoyambirira zidaperekedwa pa Msonkhano Wapachaka wa American Society of Clinical Oncology (ASCO) mu June 2025.

Pofika pa nthawi yomaliza ya kafukufuku wa pa Ogasiti 30, 2024, odwala 211 onse adasankhidwa mwachisawawa kuti alandire mankhwala osakaniza a savolitinib ndi osimertinib kapena chemotherapy. Pofuna kuchiza anthu (ITT), ofufuza adayesa kuti azitha kupulumuka popanda kupita patsogolo (PFS) kwa miyezi 8.2 ndi savolitinib kuphatikiza ndi osimertinib, poyerekeza ndi miyezi 4.5 ndi chemotherapy. Komiti yodziyimira payokha yowunikira (IRC) idayesa kuti PFS yapakati inali miyezi 7.2 poyerekeza ndi miyezi 4.2, motsatana.

Chiŵerengero cha mayankho ofunikira (ORR) chomwe chinayesedwa ndi ofufuza chinali 58% mu gulu la savolitinib kuphatikiza ndi osimertinib poyerekeza ndi 34% kwa odwala omwe anali m'gulu la chemotherapy. Chiŵerengero cha matenda (DCR) chinali 89% poyerekeza ndi 67% ndipo nthawi yapakati yoyankha (DoR) inali miyezi 8.4 poyerekeza ndi miyezi 3.2, motsatana. Kupulumuka konse sikunali kokhwima panthawi yofufuza kwakanthawi.

Zotsatira za kugwira ntchito bwino kwa odwala omwe adalandira chithandizo cha EGFR tyrosine kinase inhibitor (TKI) m'badwo wachitatu zinali zofanana ndi omwe adalandira chithandizo cha EGFR-TKI m'badwo wachitatu. Mu gulu laling'ono la odwala omwe adalandira chithandizo cha EGFR-TKI m'badwo wachitatu, PFS yapakati yomwe idawunikidwa ndi IRC inali yofanana kwambiri, yonse pa miyezi 6.9 poyerekeza ndi miyezi 3.0.

Chitetezo cha savolitinib ndi osimertinib chinali chovomerezeka ndipo palibe zizindikiro zatsopano zachitetezo zomwe zinawonedwa. Zotsatira zoyipa zomwe zimachitika chifukwa cha chithandizo cha Giredi 3 kapena kupitirira apo zidachitika mwa 57% ya odwala omwe adalandira savolitinib kuphatikiza osimertinib poyerekeza ndi 57% kwa odwala omwe adalandira chemotherapy, zomwe zikusonyeza kuti chitetezo chawo chinali chabwino.

Zokhudza ORPATHYS

ORPATHYS (savolitinib) ndi mankhwala a MET TKI opangidwa pakamwa, amphamvu komanso osankhidwa bwino omwe awonetsa kuti akugwira ntchito bwino m'matenda olimba kwambiri. Amaletsa kuyambika kwa njira ya MET receptor tyrosine kinase yomwe imachitika chifukwa cha kusintha kwa majini (monga kusintha kwa exon 14 skipping kapena kusintha kwina kwa mfundo), kukulitsa majini kapena kuchuluka kwa mapuloteni.®

Zokhudza TAGRISSO®

TAGRISSO (osimertinib) ndi EGFR-TKI ya m'badwo wachitatu, yosasinthika yokhala ndi ntchito yodziwika bwino yachipatala mu NSCLC, kuphatikizapo motsutsana ndi metastases ya dongosolo la mitsempha (CNS). TAGRISSO (mapiritsi a 40mg ndi 80mg omwe amamwedwa kamodzi patsiku) yagwiritsidwa ntchito pochiza odwala pafupifupi 800,000 malinga ndi zizindikiro zake padziko lonse lapansi ndipo AstraZeneca ikupitiliza kufufuza TAGRISSO ngati chithandizo cha odwala m'magawo osiyanasiyana a EGFRm NSCLC.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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