Ngomhlaka-29 Meyi, i-National Medical Products Administration (NMPA) yavuma i-HER2-target antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) yokukhangisa. Ikhonjiswa njengokwelashwa okukodwa kokwelapha iziguli ezindala ezinomdlavuza wamaphaphu ongewona omncane (NSCLC) ongasuswa endaweni noma osakazeke kalula onezinguquko ze-HER2 (ERBB2) ezisebenzayo futhi ezithole okungenani ukwelashwa okukodwa kwangaphambilini. Lokhu kuphawula i-ADC yokuqala ethuthukiswe eShayina evunyelwe iziguli ezine-NSCLC eguqulwe yi-HER2, enikeza inketho entsha yokwelapha yalesi siguli.
Ukuvunyelwa kusekelwe ocwaningweni olubalulekile lwe-HORIZON-Lung, oluholwa nguSolwazi Lu Shun waseShanghai Chest Hospital.
Ucwaningo lwe-HORIZON-Lung luwuvivinyo lwezokwelapha lweSigaba I/II olunezikhungo eziningi, oluvulekile, oluholwa yithimba likaSolwazi Lu Shun eShanghai Chest Hospital. Ingxenye yeSigaba I ihlose ukunquma umthamo obekezelelwe kakhulu (MTD) we-trastuzumab rezetecan nokuhlola ukusebenza kwayo kokuqala kanye nokuphepha kwayo ezigulini ezine-NSCLC eguquliwe yi-HER2. Umklamo wocwaningo wawuhlanganisa kokubili izigaba zokwanda komthamo kanye nokwanda komthamo. Engxenyeni yeSigaba I, i-trastuzumab rezetecan ibonise umsebenzi wokuqala wokulwa nomdlavuza kanye nephrofayili yokuphepha enhle. Ucwaningo lweSigaba II lwenzelwe ukuhlola kabanzi ukusebenza kahle kanye nokuphepha kwe-trastuzumab rezetecan ezigulini ezine-NSCLC eguquliwe yi-HER2.
Iziguli ezingu-94 ekugcineni zabhaliswa ocwaningweni. Imiphumela ibonise ukuthi izinga lokuphendula eliqondile (ORR), njengoba lihlolwe yiKomidi Lokubuyekeza Elizimele (IRC), lalingu-74.5%, kanti izinga lokulawula izifo (DCR) lingu-98.9%. Ubude obuphakathi bempendulo (DoR) babuyizinyanga ezingu-9.8. Ukuhlaziywa kwamaqembu amancane kubonise ukuthi ukusebenza kahle kwe-trastuzumab rezetecan kwakuhambisana kuwo wonke amaqembu amancane eziguli ahlukene, kungakhathaliseki ukwelashwa kwangaphambilini kwe-anti-HER2 tyrosine kinase inhibitor (TKI) noma ukuba khona kwe-baseline brain metastases.
I-IRC-assessed progression-free survival (PFS) ibonise i-PFS ephakathi kwezinyanga ezingu-11.5, enesilinganiso se-PFS sezinyanga ezingu-12 esingu-48.6%. I-PFS ehlolwe ngumphenyi (INV) yayiyizinyanga ezingu-12.5, enesilinganiso se-PFS sezinyanga ezingu-12 esingu-51.4%.
Idatha yokusinda iyonke (i-OS) ayikavuthwa, kanti i-OS ephakathi nendawo ingakafinyelelwa kanye nesilinganiso se-OS sezinyanga eziyi-12 esingu-88.2%.
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.
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Isikhathi sokuthunyelwe: Juni-04-2025