Pa Julayi 17, Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA) idalengeza kuti pempho lotsatsa la Trastuzumab Deruxtecan (Enhertu®) lothandizira khansa ya m'mimba lavomerezedwa mwalamulo ndi NMPA. Pempho ili cholinga chake ndi kuchiza odwala akuluakulu omwe ali ndi HER2-positive gastric or gastroesophageal junction adenocarcinoma mu mzere wachiwiri.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki ku US kokha) ndi ADC yotsogozedwa ndi HER2. Yopangidwa pogwiritsa ntchito ukadaulo wa Daiichi Sankyo wa DXd ADC, ENHERTU ndiye ADC yotsogola mu pulogalamu ya oncology ya Daiichi Sankyo komanso pulogalamu yapamwamba kwambiri mu nsanja yasayansi ya ADC ya AstraZeneca. ENHERTU ili ndi antibody ya monoclonal ya HER2 yolumikizidwa ku ma payload angapo a topoisomerase I inhibitor (yochokera ku exatecan, DXd) kudzera mu ma linker otseguka okhala ndi tetrapeptide.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Kugwiritsa ntchito mndandandawu kumadalira makamaka zotsatira zofunika kwambiri komanso zofunikira pazachipatala za kafukufuku wa DESTINY-Gstric04 (zomwe zidaperekedwa ku Msonkhano wa American Society of Clinical Oncology ASCO mu 2025).
DESTINY-Gastric04 (NCT04704934), kafukufuku wapadziko lonse lapansi, wosasankhidwa, wapakati, wotseguka, gawo lachitatu loyesa mphamvu ndi chitetezo cha T DXd vs RAM + PTX mu pts ndi HER2+ yosasinthika/yosasinthika GC/GEJA mu mzere wachiwiri uwu.
Njira:
Pambuyo pa kutsimikizika kwa biopsy kwa HER2+ status (IHC 3+ kapena IHC 2+/ISH+), ma pts adasinthidwa mwachisawawa 1:1 ku T-DXd 6.4 mg/kg kapena RAM + PTX. Ma endpoint oyamba anali opulumuka onse (OS). OS pakati pa mikono iwiriyi idayerekezeredwa ndi mayeso a log-rank omwe adagawidwa pogwiritsa ntchito zinthu zosasinthika. Ma endpoint achiwiri ndi kuwunika kwa ofufuza akuphatikizapo kupulumuka kopanda progression (PFS), confirmed objective response rate (cORR), disease control rate (DCR), ndi chitetezo.
Zotsatira:
Pa nthawi yomaliza deta (Okutobala 24, 2024), ma pts 494 adaperekedwa (T-DXd, n = 246; RAM + PTX, n = 248). Kutengera ndi zochitika 266 za OS zomwe zawonedwa (gawo la chidziwitso = 78.5%), kupambana kwa magwiridwe antchito kunapezeka (2-sided P < 0.0228). Kutsatira kwapakati (m) (95% CI) OS kunali 16.8 miyezi (14.0-20.0) ya T-DXd ndi 14.4 miyezi (13.1-19.7) ya RAM + PTX. mOS (95% CI) inali 14.7 miyezi (12.1-16.6) ya T-DXd motsutsana ndi 11.4 miyezi (9.9-15.5) ya RAM + PTX (chiŵerengero cha zoopsa [HR], 0.70; P = 0.0044). Deta yowonjezera yogwira ntchito ili mu Table. Nthawi yapakati (yomwe imachitika) ya chithandizo inali miyezi 5.4 (0.7-30.3) ndi T-DXd ndi miyezi 4.6 (0.9-34.9) ndi RAM + PTX. Zochitika zoyipa zomwe zimachitika mwadzidzidzi (TEAEs) zidanenedwa mu 244/244 (100%) poyerekeza ndi 228/233 pts (97.9%) ndi T-DXd poyerekeza ndi RAM + PTX, motsatana; 68.0% poyerekeza ndi 73.8% zinali kalasi (G) ≥3. Ma TEAE oopsa ndi T-DXd poyerekeza ndi RAM + PTX adachitika mu 41.0% poyerekeza ndi 43.3% ya pts; Ma TEAE okhudzana ndi kusiya kugwiritsa ntchito mankhwala adachitika mu 14.3% poyerekeza ndi 17.2% ya pts. Matenda a m'mapapo/chibayo omwe amachitidwa ndi mankhwala osagwirizana ndi mankhwala adachitika pa 34 pts (13.9%) ndi T-DXd (1 G3, 0 G4/5) poyerekeza ndi 3 pts (1.3%) ndi RAM + PTX (2 G3, 1 G5).
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Email：myimmnet@163.com
Nthawi yotumizira: Julayi-22-2025