Ngomhla we-17 kweyeKhala, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba isicelo sokuthengisa seTrastuzumab Deruxtecan (i-Enhertu®) sonyango lomhlaza wesisu lomgca wesibini samkelwe ngokusesikweni yi-NMPA. Esi sicelo senzelwe unyango lwezigulane zabantu abadala abane-HER2-positive gastric or gastroesophageal junction adenocarcinoma kumgca wesibini.
I-ENHERTU (i-trastuzumab deruxtecan; i-fam-trastuzumab deruxtecan-nxki e-US kuphela) yi-ADC eqondiswe yi-HER2. Yenzelwe kusetyenziswa iTekhnoloji ye-DXd ADC kaDaiichi Sankyo, i-ENHERTU yi-ADC ephambili kwipotifoliyo ye-oncology ye-Daiichi Sankyo kunye nenkqubo ephambili kwiqonga lesayensi le-ADC le-AstraZeneca. I-ENHERTU ine-antibody ye-HER2 monoclonal eqhotyoshelwe kwinani lee-topoisomerase I inhibitor payloads (i-exatecan derivative, DXd) nge-tetrapeptide-based cleavable linkers.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
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Email：myimmnet@163.com
Olu setyenziso loluhlu lusekelwe ikakhulu kwiziphumo ezibalulekileyo ngokwezibalo nezibalulekileyo zesifundo se-DESTINY-Gstric04 (ezavezwa kwiNgqungquthela ye-ASCO ye-American Society of Clinical Oncology ngo-2025).
I-DESTINY-Gastric04 (NCT04704934), uphando lwesigaba sesi-3 lwehlabathi, olucwangcisiweyo, oluneziko elininzi, oluvulelekileyo, oluvavanya ukusebenza kakuhle kunye nokhuseleko lwe-T DXd vs RAM + PTX kwi-pts ene-HER2+ engasuswayo/i-metastatic GC/GEJA kolu lungiselelo lomgca wesibini.
Iindlela:
Emva kokuba imeko ye-HER2+ iqinisekisiwe yi-biopsy (IHC 3+ okanye IHC 2+/ISH+), ii-pts zenziwe ngokungacwangciswanga nge-1:1 ukuya kwi-T-DXd 6.4 mg/kg okanye i-RAM + PTX. Isiphelo esiphambili yayiyi-overall survival (OS). I-OS phakathi kweengalo ezimbini ithelekiswe ngovavanyo lwe-log-rank oluhlulwe kusetyenziswa izinto ezingacwangciswanga. Iisiphelo zesibini nguphando lophando ziquka ukusinda okungenankqubela phambili (PFS), izinga lokuphendula eliqinisekisiweyo (cORR), izinga lokulawula izifo (DCR), kunye nokhuseleko.
Iziphumo:
Kwisiphelo sedatha (nge-24 ka-Okthobha, 2024), kwabelwa ii-pts ezingama-494 (T-DXd, n = 246; RAM + PTX, n = 248). Ngokusekelwe kwiziganeko ze-OS ezingama-266 ezibonwe (iqhezu lolwazi = 78.5%), ukugqwesa kokusebenza kakuhle kufezekisiwe (2-side P < 0.0228). Ukulandelelana kwe-OS ephakathi (m) (95% CI) yayiyi-16.8 mo (14.0-20.0) ye-T-DXd kunye ne-14.4 mo (13.1-19.7) ye-RAM + PTX. i-mOS (95% CI) yayiyi-14.7 mo (12.1-16.6) ye-T-DXd vs 11.4 mo (9.9-15.5) ye-RAM + PTX (umlinganiselo wobungozi [HR], 0.70; P = 0.0044). Idatha eyongezelelweyo yokusebenza kakuhle ikwiTheyibhile. Ubude bexesha lonyango oluphakathi (uluhlu) yayiyiinyanga eziyi-5.4 (0.7-30.3) nge-T-DXd kunye neenyanga eziyi-4.6 (0.9-34.9) nge-RAM + PTX. Iziganeko ezimbi ezivelelayo zonyango (ii-TEAE) zibikwe kwi-244/244 (100%) xa kuthelekiswa ne-228/233 pts (97.9%) nge-T-DXd xa kuthelekiswa ne-RAM + PTX, ngokwahlukeneyo; 68.0% xa kuthelekiswa ne-73.8% zazikwi-grade (G) ≥3. Ii-TEAE ezinzulu ezine-T-DXd xa kuthelekiswa ne-RAM + PTX zenzeke kwi-41.0% xa kuthelekiswa ne-43.3% yee-pts; Ii-TEAE ezinxulumene nokuyeka ukusebenzisa iziyobisi zenzeke kwi-14.3% xa kuthelekiswa ne-17.2% yee-pts. Isifo/i-pneumonia ye-interstitial lung echazwe ngokuzimeleyo yenzeke kwi-34 pts (13.9%) ene-T-DXd (1 G3, 0 G4/5) xa kuthelekiswa ne-3 pts (1.3%) ene-RAM + PTX (2 G3, 1 G5).
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Ixesha leposi: Julayi-22-2025