Ngomhla wama-29 kuCanzibe, iNational Medical Products Administration (NMPA) yavuma i-HER2-targeted antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) ukuze ithengiswe. Iboniswa njenge-monotherapy yokunyanga izigulane ezindala ezine-non-resectable local advanced okanye i-metastatic non-small cell lung cancer (NSCLC) ezine-activated HER2 (ERBB2) mutations kwaye zifumene ubuncinane unyango olunye lwangaphambili. Oku kubonisa i-ADC yokuqala ephuhliswe eTshayina evunyiweyo kwizigulane ezine-HER2-mutated NSCLC, enika ukhetho olutsha lonyango kwesi sigulane.
Olu vunyiweyo lusekelwe kuphando olubalulekileyo lwe-HORIZON-Lung, olukhokelwa nguNjingalwazi uLu Shun waseShanghai Chest Hospital.
Uphononongo lweHORIZON-Lung luvavanyo lweklinikhi oluneziko elibanzi, oluvulelekileyo, lweSigaba I/II olukhokelwa liqela likaNjingalwazi uLu Shun kwiSibhedlele saseShanghai Chest. Inxalenye yeSigaba I yayijolise ekumiseleni idosi ephezulu enyanyezelwayo (MTD) ye-trastuzumab rezetecan kunye nokuvavanya ukusebenza kwayo kokuqala kunye nokhuseleko kwizigulane ezine-NSCLC eguqulwe yi-HER2. Uyilo lophononongo lwaluquka zombini izigaba zokunyuka kwedosi kunye nokwandiswa kwedosi. Kwinxalenye yeSigaba I, i-trastuzumab rezetecan ibonakalise umsebenzi wokuqala wokulwa nethumba kunye neprofayili yokhuseleko efanelekileyo. Uphononongo lweSigaba II lwaluyilelwe ukuvavanya ngakumbi ukusebenza kakuhle kunye nokhuseleko lwe-trastuzumab rezetecan kwizigulane ezine-NSCLC eguqulwe yi-HER2.
Ekugqibeleni izigulane ezingama-94 zibhalisiwe kolu phando. Iziphumo zibonise ukuba izinga lokuphendula elijolise ngqo (ORR), njengoko lihlolwe yiKomiti yoHlolo oluZimeleyo (IRC), yayiyi-74.5%, kunye nezinga lokulawula isifo (DCR) eliyi-98.9%. Ubude obuphakathi bempendulo (DoR) yayiziinyanga eziyi-9.8. Uhlalutyo lwamaqela amancinci lubonise ukuba ukusebenza kakuhle kwe-trastuzumab rezetecan kwakufana kumaqela ahlukeneyo ezigulana, nokuba unyango lwangaphambili lwe-anti-HER2 tyrosine kinase inhibitor (TKI) okanye ukubakho kwe-baseline brain metastases.
I-IRC-assessed progression-free survival (PFS) ibonise i-PFS ephakathi yeenyanga ezili-11.5, kunye nezinga le-PFS leenyanga ezili-12 elingama-48.6%. I-PFS ehlolwe ngumphengululi (INV) yayiziinyanga ezili-12.5, kunye nezinga le-PFS leenyanga ezili-12 elingama-51.4%.
Idatha yokusinda iyonke (OS) ayikavuthwa, i-avareji ye-OS ayikafikelelwa kwaye izinga le-OS leenyanga ezili-12 liyi-88.2%.
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.
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Ixesha lokuthumela: Juni-04-2025