Ma Iulai 17, ua hoʻolaha ke Kikowaena no ka Loiloi Lāʻau Lapaʻau (CDE) o ka National Medical Products Administration (NMPA) ua ʻae kūhelu ʻia ka noi kūʻai aku no Trastuzumab Deruxtecan (Enhertu®) no ka lāʻau lapaʻau laina ʻelua o ka maʻi ʻōpū e ka NMPA. Ua manaʻo ʻia kēia noi no ka mālama ʻana i nā maʻi makua me HER2-positive gastric a i ʻole gastroesophageal junction adenocarcinoma ma ka hoʻonohonoho laina ʻelua.
ʻO ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki ma US wale nō) he ADC i kuhikuhi ʻia e HER2. Hoʻolālā ʻia me ka hoʻohana ʻana i ka ʻenehana DXd ADC ponoʻī a Daiichi Sankyo, ʻo ENHERTU ke alakaʻi ADC ma ka waihona oncology o Daiichi Sankyo a me ka papahana holomua loa ma ka paepae ʻepekema ADC a AstraZeneca. Aia ʻo ENHERTU i kahi antibody monoclonal HER2 i hoʻopili ʻia i kahi helu o nā topoisomerase I inhibitor payloads (kahi exatecan derivative, DXd) ma o nā mea hoʻopili cleavable i hoʻokumu ʻia i ka tetrapeptide.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
ʻIkepili WeChat: 17801183037
Email：myimmnet@163.com
Hoʻokumu nui ʻia kēia noi papa inoa ma nā hopena koʻikoʻi helu a me nā hopena koʻikoʻi o ke aʻo ʻana ʻo DESTINY-Gstric04 (i hōʻike ʻia ma ka American Society of Clinical Oncology ASCO Conference ma 2025).
ʻO DESTINY-Gastric04 (NCT04704934), he haʻawina honua, randomized, multicenter, open-label, phase 3 e loiloi ana i ka pono a me ka palekana o T DXd vs RAM + PTX i nā pts me HER2+ unresectable/metastatic GC/GEJA ma kēia hoʻonohonoho laina lua.
Nā Hana:
Ma hope o ke kūlana HER2+ i hōʻoia ʻia e ka biopsy (IHC 3+ a i ʻole IHC 2+/ISH+), ua koho wale ʻia nā pts 1:1 i T-DXd 6.4 mg/kg a i ʻole RAM + PTX. ʻO ke kumu mua ka ola holoʻokoʻa (OS). Ua hoʻohālikelike ʻia ʻo OS ma waena o nā lima ʻelua e kahi hoʻāʻo log-rank i hoʻokaʻawale ʻia me ka hoʻohana ʻana i nā kumu randomization. ʻO nā kumu lua e ka loiloi mea noiʻi e komo pū me ke ola ʻole o ka holomua (PFS), ka helu pane i hōʻoia ʻia (cORR), ka helu kaohi maʻi (DCR), a me ka palekana.
Nā Hualoaʻa:
Ma ka ʻoki ʻikepili (ʻOkakopa 24, 2024), ua hāʻawi ʻia he 494 mau pts (T-DXd, n = 246; RAM + PTX, n = 248). Ma muli o 266 mau hanana OS i ʻike ʻia (ʻāpana ʻike = 78.5%), ua hoʻokō ʻia ka ʻoi aku ka maikaʻi o ka efficacy (2-ʻaoʻao P < 0.0228). ʻO ka Median (m) (95% CI) OS follow-up he 16.8 mo (14.0-20.0) no T-DXd a me 14.4 mo (13.1-19.7) no RAM + PTX. ʻO mOS (95% CI) he 14.7 mo (12.1-16.6) no T-DXd vs 11.4 mo (9.9-15.5) no RAM + PTX (hazard ratio [HR], 0.70; P = 0.0044). Aia nā ʻikepili efficacy hou aʻe ma ka Papa. ʻO ka lōʻihi waena (pae) o ka mālama ʻana he 5.4 mahina (0.7-30.3) me T-DXd a me 4.6 mahina (0.9-34.9) me RAM + PTX. Ua hōʻike ʻia nā hanana ʻino i hoʻomaka i ka mālama ʻana (TEAE) ma 244/244 (100%) vs 228/233 pts (97.9%) me T-DXd vs RAM + PTX, kēlā me kēia; 68.0% vs 73.8% he papa (G) ≥3. Ua loaʻa nā TEAE koʻikoʻi me T-DXd vs RAM + PTX ma 41.0% vs 43.3% o nā pts; Ua loaʻa nā TEAE e pili ana me ka hoʻopau ʻana i ka lāʻau lapaʻau ma 14.3% vs 17.2% o nā pts. Ua ʻike ʻia ka maʻi māmā interstitial/pneumonitis e pili ana i ka lāʻau lapaʻau i 34 mau pts (13.9%) me T-DXd (1 G3, 0 G4/5) vs 3 mau pts (1.3%) me RAM + PTX (2 G3, 1 G5).
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Email：myimmnet@163.com
Ka manawa hoʻouna: Iulai-22-2025