I-PLB1004, eyasungulwa yi-Beijing Avistone Biotechnology Co., Ltd., iyi-inhibitor ye-epidermal growth factor receptor ephephile, ekhetha kakhulu, futhi esebenza kahle kakhulu (EGFR-TKI) esetshenziswa ekwelapheni umdlavuza wamaphaphu ongewona amaseli amancane (i-NSCLC).
Ngomhlaka-9 kuMbasa 2025, iNational Medical Products Administration Drug Evaluation Center (CDE) ikhombisile ukuthi i-PLB1004 yeBeijing Avistone Biotechnology yayihloselwe ukufakwa ekwelashweni okuphumelelayo kweziguli ezinomdlavuza wamaphaphu ongewona omncane (NSCLC) othuthuke endaweni noma i-METastatic, ezazinokuguqulwa kwe-EGFR, zathola ukwanda kanye/noma ukuvezwa ngokweqile ngemuva kokwehluleka kokwelashwa kwe-EGFR-TKI.
Imiphumela yokuqala yezokwelapha ye-PLB1004 ehlanganiswe ne-Vebreltinib ekwelapheni iziguli zomdlavuza wamaphaphu ezingezona ezincane ezinezinguquko ze-EGFR, ukukhuliswa kwe-MET noma ukuvezwa ngokweqile kwe-MET ngemva kwe-EGFR-TKI yamenyezelwa eNgqungqutheleni Yomhlaba wonke Yomdlavuza Wamaphaphu ka-2024.
Iziguli ezingamashumi amane nane zithole i-Vebreltinib 100mg kanye ne-PLB1004 160mg (n=15), i-Vebreltinib 150mg kanye ne-PLB1004 160mg (n=13), i-Vebreltinib 200mg kanye ne-PLB1004 80mg (n=3), noma i-Vebreltinib 150mg kanye ne-PLB1004 80mg (n=13) futhi zafakwa ekuhlaziyweni kokuphepha okuphelele. Phakathi kweziguli ezingu-44 ezihlolwe, ama-36.4% eziguli ayene-metastases yobuchopho kanti ama-86.4% eziguli ayethole i-EGFR-TKI yesizukulwane sesithathu ngaphambilini, ngokulandelana. Izimpendulo eziqondile zenzeke kuzo zonke amazinga omthamo we-Vebreltinib kanye ne-PLB1004 ahlolwe, kanti izimpendulo ezingaphelele (ama-PR) zabonwa ezigulini ezihlolwa impendulo ezingu-19/32 (59.4%). Phakathi kweziguli ezine-metastases yobuchopho, i-ORR yayingu-75.0% (9/12). I-ORR yayingu-58.6% (17/29) ezigulini ezathola i-EGFR-TKI yesizukulwane sesithathu ngaphambilini. Ama-TRAE avame kakhulu kwakungama-rash kanye ne-paronychia. Azikho iziguli ezayeka ukwelashwa ngenxa yama-TRAE.
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
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Ephreli-10-2025