Ngomhlaka-17 kuJulayi, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yamemezela ukuthi isicelo sokumaketha se-Trastuzumab Deruxtecan (Enhertu®) sokwelashwa komdlavuza wesisu komugqa wesibili sesamukelwe ngokusemthethweni yi-NMPA. Lesi sicelo senzelwe ukwelashwa kweziguli ezindala ezine-HER2-positive gastric or gastroesophageal junction adenocarcinoma endaweni yesibili.
I-ENHERTU (i-trastuzumab deruxtecan; i-fam-trastuzumab deruxtecan-nxki e-US kuphela) iyi-ADC eqondiswe yi-HER2. Yaklanywa kusetshenziswa ubuchwepheshe be-DXd ADC obuyimpahla kaDaiichi Sankyo, i-ENHERTU iyi-ADC ehamba phambili kuphothifoliyo ye-oncology ye-Daiichi Sankyo kanye nohlelo oluthuthuke kakhulu epulatifomu yesayensi ye-ADC ye-AstraZeneca. I-ENHERTU iqukethe i-antibody ye-HER2 monoclonal enamathiselwe eningini le-topoisomerase I inhibitor payloads (i-exatecan derivative, DXd) ngezixhumanisi eziqhekekayo ezisekelwe ku-tetrapeptide.
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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Lolu hlelo lokusebenza lokufakwa ohlwini lusekelwe kakhulu emiphumeleni ebalulekile ngokwezibalo kanye nebalulekile ngokwezokwelapha yocwaningo lwe-DESTINY-Gstric04 (olwethulwe eNgqungqutheleni ye-American Society of Clinical Oncology ASCO ngo-2025).
I-DESTINY-Gastric04 (NCT04704934), ucwaningo lwesigaba sesi-3 lomhlaba wonke, olungahleliwe, olunezikhungo eziningi, olunelebula evulekile, oluhlola ukusebenza kahle kanye nokuphepha kwe-T DXd vs RAM + PTX kuma-pts ane-HER2+ engasuswa/i-metastatic GC/GEJA kulesi simo somugqa wesibili.
Izindlela:
Ngemva kokuqinisekiswa kwesimo se-HER2+ nge-biopsy (IHC 3+ noma i-IHC 2+/ISH+), ama-pts ahlelwe ngokungahleliwe ngo-1:1 kuya ku-T-DXd 6.4 mg/kg noma i-RAM + PTX. Iphuzu eliyinhloko kwakuyi-overall survival (OS). I-OS phakathi kwezingalo ezimbili iqhathaniswe nokuhlolwa kwe-log-rank okuhlukaniswe kusetshenziswa izici ezingahleliwe. Amaphuzu esibili okuhlolwa ngumcwaningi afaka phakathi ukusinda okungenakho ukuqhubekela phambili (PFS), izinga lokuphendula eliqinisekisiwe (cORR), izinga lokulawula izifo (DCR), kanye nokuphepha.
Imiphumela:
Ekunqanyulweni kwedatha (ngo-Okthoba 24, 2024), kwanikezwa amaphuzu angu-494 (T-DXd, n = 246; RAM + PTX, n = 248). Ngokusekelwe ezenzakalweni ze-OS ezingu-266 ezibonwe (ingxenye yolwazi = 78.5%), ukuphakama kokusebenza kahle kufinyelelwe (2-sided P < 0.0228). Ukulandelwa kwe-OS okumaphakathi (m) (95% CI) kwaba izinyanga ezingu-16.8 (14.0-20.0) ze-T-DXd kanye nezinyanga ezingu-14.4 (13.1-19.7) ze-RAM + PTX. i-mOS (95% CI) yayizinyanga ezingu-14.7 (12.1-16.6) ze-T-DXd vs izinyanga ezingu-11.4 (9.9-15.5) ze-RAM + PTX (isilinganiso sengozi [HR], 0.70; P = 0.0044). Idatha eyengeziwe yokusebenza kahle ikuThebula. Isikhathi esimaphakathi sokwelashwa (ububanzi) sasiyizinyanga ezingu-5.4 (0.7-30.3) nge-T-DXd kanye nezinyanga ezingu-4.6 (0.9-34.9) nge-RAM + PTX. Izehlakalo ezimbi ezivele ngokushesha (TEAEs) zabikwa ku-244/244 (100%) vs 228/233 pts (97.9%) nge-T-DXd vs RAM + PTX, ngokulandelana; 68.0% vs 73.8% zaziyibanga (G) ≥3. Ama-TEAE angathi sína nge-T-DXd vs RAM + PTX enzeka ku-41.0% vs 43.3% wama-pts; Ama-TEAE ahlobene nokuyekiswa kwemithi enzeka ku-14.3% vs 17.2% wama-pts. Isifo samaphaphu/i-pneumonia esihlobene nemithi esinqunyiwe ngokuzimela senzeke kuma-pts angu-34 (13.9%) nge-T-DXd (1 G3, 0 G4/5) uma kuqhathaniswa nama-pts angu-3 (1.3%) nge-RAM + PTX (2 G3, 1 G5).
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: Julayi-22-2025