Ngomhlaka-29 kuNcwaba, i-HERNEXEOS® kaBoehringer Ingelheim (amaphilisi e-zongertinib) ivunyelwe njengokwelashwa okukodwa yi-National Medical Products Administration (NMPA) yaseShayina yokwelapha iziguli ezindala ezinomdlavuza wamaphaphu ongewona omncane (i-NSCLC) ongasuswa, othuthuke endaweni noma osakazeka kalula onezimila ezinezinguquko ze-HER2 (ERBB2) ezisebenzayo futhi ezithole okungenani umugqa owodwa wokwelashwa kwesistimu ngaphambilini.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Ukuvunyelwa okunemibandela kunikezwe ngokusekelwe kudatha evela kusilingo se-Phase Ib Beamion-LUNG 1 (NCT04886804): Isilingo sokukhushulwa komthamo weSigaba I, esinokuqinisekiswa komthamo kanye nokwandiswa, se-zongertinib njengokwelashwa okukodwa kubantu abanezimila eziqinile ezingasuswa noma ezisakazeka kalula ezinezinguquko ze-HER2. Ucwaningo lunezingxenye ezimbili. Ingxenye yokuqala ivulekele abantu abadala abanezinhlobo ezahlukene zomdlavuza othuthukile onezinguquko ze-HER2 ezifaka phakathi ukuguqulwa kwezakhi zofuzo, ukukhulisa, ukuvezwa ngokweqile kanye nokuhlanganiswa okwakungekho mpumelelo kubo ukwelashwa kwangaphambilini. Ingxenye yesibili ivulekele abantu abanomdlavuza wamaphaphu we-HER2-mutant non-small cell.
Kuqembu 1, iziguli ezingu-75 sezizonke zathola i-zongertinib ngomthamo ongu-120 mg. Ngesikhathi sokuhlolwa kwedatha (ngoNovemba 29, 2024), ama-71% alezi ziguli (95% isikhathi sokuzethemba [CI], ama-60 kuya ku-80; P<0.001 uma kuqhathaniswa nesilinganiso esingu-≤30%) babe nempendulo eqondile eqinisekisiwe; ubude besikhathi esimaphakathi sempendulo babuyizinyanga ezingu-14.1 (95% CI, 6.9 kuya ku-ayilinganiswa), kanti ukusinda okumaphakathi okungenalo ukuqhubekela phambili kwakuyizinyanga ezingu-12.4 (95% CI, 8.2 kuya ku-ayilinganiswa). Izehlakalo ezimbi ezihlobene nezidakamizwa zebanga lesi-3 noma ngaphezulu zenzeka ezigulini ezingu-13 (17%). Kuqembu 5 (iziguli ezingu-31), ama-48% eziguli (95% CI, 32 kuya ku-65) babe nempendulo eqondile eqinisekisiwe. Izehlakalo ezimbi ezihlobene nezidakamizwa zebanga lesi-3 noma ngaphezulu zenzeka esigulini esisodwa (3%). Ku-cohort 3 (iziguli ezingu-20), u-30% weziguli (95% CI, 15 kuya ku-52) babe nempendulo eqinisekisiwe eqondile. Izehlakalo ezimbi ezihlobene nezidakamizwa zebanga lesi-3 noma ngaphezulu zenzeke ezigulini ezi-5 (25%). Kuzo zonke izigaba ezintathu, azikho izimo zesifo samaphaphu esihlobene nezidakamizwa ezenzekayo.
“Kuyakhuthaza ukubona ukuqhubeka kwe-NMPA iqaphela amandla e-zongertinib. Ukwelashwa Okuthuthukisiwe Ukuqokwa kokusetshenziswa kokuqala kwe-zongertinib eShayina kubonisa isidingo esiphuthumayo saleli qembu leziguli. Kuyisinyathelo esilandelayo esibalulekile sokwenza lokhu kwelashwa kutholakale ezigulini eziningi ezikudingayo,” kusho uShashank Deshpande, uSihlalo weBhodi Yabaqondisi Abaphethe eBoehringer Ingelheim.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Septhemba-02-2025