Ngomhla wama-29 ku-Agasti, i-HERNEXEOS® kaBoehringer Ingelheim (iipilisi ze-zongertinib) ivunyiwe njenge-monotherapy yi-National Medical Products Administration (NMPA) yaseTshayina yokunyanga izigulane zabantu abadala abanomhlaza wamaphaphu ongengoweseli omncinci (i-NSCLC) ongenakususwa, oqhubekekayo okanye osasazekayo kwiiseli ezincinci (i-NSCLC) ezineethumba ezine-HER2 (ERBB2) evuselelayo kwaye ezifumene ubuncinane umgca omnye wonyango lwangaphambili.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Imvume exhomekeke kwimiqathango inikwe ngokusekelwe kwidatha evela kuvavanyo lweSigaba Ib Beamion-LUNG 1 (NCT04886804): Uvavanyo oluvulekileyo, uvavanyo lokunyusa umthamo weSigaba I, olunokuqinisekiswa kwedosi kunye nokwandiswa, lwe-zongertinib njenge-monotherapy kubantu abane-tumor eqinileyo engasuswayo okanye eguquliweyo ene-HER2 alterations. Olu phononongo luneenxalenye ezi-2. Inxalenye yokuqala ivulelekile kubantu abadala abaneentlobo ezahlukeneyo zomhlaza ophucukileyo one-HER2 alterations ezibandakanya ukuguqulwa kwezakhi zofuzo, ukwanda, ukubonakaliswa okugqithisileyo kunye nokuhlanganiswa kwabo unyango lwangaphambili olungazange luphumelele. Inxalenye yesibini ivulelekile kubantu abanomhlaza wemiphunga we-HER2-mutant non-small cell.
Kwiqela lokuqala, izigulane ezingama-75 zizonke zafumana i-zongertinib ngedosi ye-120 mg. Kwisithuba sedatha (nge-29 kaNovemba 2024), i-71% yezi zigulane (95% isithuba sokuzithemba [CI], 60 ukuya kuma-80; P<0.001 xa kuthelekiswa nomlinganiselo we-≤30%) zazinempendulo eqinisekisiweyo; ubude bexesha eliphakathi lempendulo yayiyiinyanga ezili-14.1 (95% CI, 6.9 ukuya kutsho kuvavanyo), kwaye ukusinda okuphakathi okungenankqubela phambili yayiyiinyanga ezili-12.4 (95% CI, 8.2 ukuya kutsho kuvavanyo). Iziganeko ezimbi ezinxulumene neziyobisi zeBanga lesi-3 nangaphezulu zenzekile kwizigulane ezili-13 (17%). Kwiqela lesi-5 (izigulane ezingama-31), i-48% yezigulane (95% CI, 32 ukuya kuma-65) zazinempendulo eqinisekisiweyo eqinisekileyo. Iziganeko ezimbi ezinxulumene neziyobisi zeBanga lesi-3 nangaphezulu zenzekile kwisigulane esinye (3%). Kwiqela lesi-3 (izigulane ezingama-20), ama-30% ezigulane (95% CI, 15 ukuya kuma-52) afumene impendulo eqinisekisiweyo. Iziganeko ezimbi ezinxulumene neziyobisi zebanga lesi-3 okanye ngaphezulu zenzeke kwizigulane ezi-5 (25%). Kuzo zonke ezi qela zithathu, akukho matyala esifo semiphunga esinxulumene neziyobisi awenzekileyo.
“Kuyakhuthaza ukubona i-NMPA iqhubeka nokuqaphela amandla e-zongertinib. Unyango oluPhambili Ukuchonga ukusetyenziswa kwe-zongertinib kumgca wokuqala eTshayina kubonisa imfuneko engxamisekileyo kweli nani lezigulana. Linyathelo elilandelayo elibalulekileyo lokwenza olu nyango lufumaneke kwizigulane ezininzi eziludingayo,” utshilo uShashank Deshpande, uSihlalo weBhodi yabaLawuli abaLawulayo eBoehringer Ingelheim.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Ixesha leposi: Sep-02-2025