Musi wa17 Chikunguru, Center for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yakazivisa kuti chikumbiro chekushambadzira cheTrastuzumab Deruxtecan (Enhertu®) chekurapa kenza yemudumbu chechipiri chagamuchirwa zviri pamutemo neNMPA. Chikumbiro ichi chakagadzirirwa kurapa varwere vakuru vane HER2-positive gastric or gastroesophageal junction adenocarcinoma muchikamu chechipiri.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki muUS chete) iADC inotungamirwa neHER2. Yakagadzirwa uchishandisa Daiichi Sankyo's proprietary DXd ADC Technology, ENHERTU ndiyo ADC inotungamira mu oncology portfolio yeDaiichi Sankyo uye chirongwa chepamusoro-soro muAstraZeneca's ADC scientific platform. ENHERTU ine HER2 monoclonal antibody yakabatana nenhamba ye topoisomerase I inhibitor payloads (exatecan derivative, DXd) kuburikidza ne tetrapeptide-based cleavable linkers.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Nhamba yeWeChat: 17801183037
Email：myimmnet@163.com
Chikumbiro ichi chekunyoresa chakavakirwa zvakanyanya pamhedzisiro yakakosha uye yakakosha yeongororo yeDESTINY-Gstric04 (yakapihwa paAmerican Society of Clinical Oncology ASCO Conference muna 2025).
DESTINY-Gastric04 (NCT04704934), chidzidzo chepasi rose, chakasarudzika, chine nzvimbo dzakawanda, chakavhurika, chikamu chechitatu chinoongorora kushanda uye kuchengetedzeka kweT DXd vs RAM + PTX mumapts ane HER2+ isingabvisike/metastatic GC/GEJA muchikamu chino chechipiri.
Maitiro:
Mushure mekunge biopsy yasimbisa mamiriro eHER2+ (IHC 3+ kana IHC 2+/ISH+), ma pts akasarongerwa 1:1 kusvika kuT-DXd 6.4 mg/kg kana RAM + PTX. Mugumo wekutanga waive wekurarama kwese (OS). OS iri pakati pemaoko maviri yakaenzaniswa ne log-rank test yakarongwa uchishandisa zvinhu zvisingatarisirwi. Ma endpoints echipiri neongororo yevaongorori anosanganisira progression-free survival (PFS), confirmed objective response rate (cORR), disease control rate (DCR), uye safety.
Mhedzisiro:
Pakachekwa data (Gumiguru 24, 2024), 494 pts dzakapihwa (T-DXd, n = 246; RAM + PTX, n = 248). Zvichibva pazviitiko 266 zveOS zvakaonekwa (chikamu cheruzivo = 78.5%), kugona kwepamusoro kwakawanikwa (2-sided P < 0.0228). Kutevera kwepakati (m) (95% CI) OS kwaive 16.8 mwedzi (14.0-20.0) yeT-DXd uye 14.4 mwedzi (13.1-19.7) yeRAM + PTX. mOS (95% CI) yaive 14.7 mwedzi (12.1-16.6) yeT-DXd vs 11.4 mwedzi (9.9-15.5) yeRAM + PTX (hazard ratio [HR], 0.70; P = 0.0044). Mamwe mashoko ekushanda ari muTafura. Nguva yepakati (yekurapwa) yaive mwedzi 5.4 (0.7-30.3) neT-DXd uye mwedzi 4.6 (0.9-34.9) neRAM + PTX. Zviitiko zvisina kunaka zvekurapa (TEAEs) zvakataurwa mu244/244 (100%) vs 228/233 pts (97.9%) neT-DXd vs RAM + PTX, zvichiteerana; 68.0% vs 73.8% zvaive zvegiredhi (G) ≥3. MaTEAE akakomba neT-DXd vs RAM + PTX akaitika mu41.0% vs 43.3% yepts; MaTEAE ane chekuita nekurega kushandisa mushonga akaitika mu14.3% vs 17.2% yepts. Chirwere chemapapu/pneumonia chakabatana nemishonga chakaonekwa pachacho muzvikamu makumi matatu nemana (13.9%) neT-DXd (1 G3, 0 G4/5) vs zvikamu zvitatu (1.3%) neRAM + PTX (2 G3, 1 G5).
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Nguva yekutumira: Chikunguru-22-2025