Na Julaị 17, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) kwupụtara na NMPA anabatala ngwa ahịa maka Trastuzumab Deruxtecan (Enhertu®) maka ọgwụgwọ nke abụọ nke kansa afọ. A na-eme ngwa a maka ọgwụgwọ ndị okenye nwere adenocarcinoma afọ ma ọ bụ nke gastroesophageal n'ọnọdụ nke abụọ.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki na US naanị) bụ ADC nke HER2 duziri. E ji teknụzụ DXd ADC nke Daiichi Sankyo mepụtara ya, ENHERTU bụ ADC mbụ na ngalaba oncology nke Daiichi Sankyo na mmemme kachasị elu na ikpo okwu sayensị ADC nke AstraZeneca. ENHERTU nwere ọgwụ mgbochi HER2 monoclonal nke ejikọtara na ọtụtụ ibu ọrụ topoisomerase I inhibitor (ihe exatecan derivative, DXd) site na njikọ ndị a na-apụghị ịgbagha agbagha dabere na tetrapeptide.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Ngwa a na-etinye na ndepụta dabere na nsonaazụ dị mkpa na nke dị mkpa n'ọgwụgwọ nke ọmụmụ ihe DESTINY-Gstric04 (nke e gosipụtara na ogbako ASCO nke American Society of Clinical Oncology na 2025).
DESTINY-Gastric04 (NCT04704934), ọmụmụ zuru ụwa ọnụ, nke a na-ahazighị ahazi, nke nwere ọtụtụ etiti, nke mepere emepe, nke na-enyocha arụmọrụ na nchekwa nke T DXd vs RAM + PTX na pts yana HER2+ nke a na-apụghị ịgbanahụ/metastatic GC/GEJA na ntọala ahịrị nke abụọ a.
Ụzọ:
Mgbe e mechara nyocha nke gosiri na ọrịa HER2+ dị na biopsy (IHC 3+ ma ọ bụ IHC 2+/ISH+), e jiri usoro nyocha mee ihe site na 1:1 ruo T-DXd 6.4 mg/kg ma ọ bụ RAM + PTX. Isi ihe dị na njedebe bụ ndụ zuru oke (OS). E jiri ule ọkwa log-rank tụnyere OS dị n'etiti ogwe aka abụọ ahụ site na iji ihe ndị na-enweghị usoro. Isi ihe nke abụọ site na nyocha onye nyocha gụnyere ndụ na-enweghị ọganihu (PFS), ọnụego nzaghachi ebumnuche akwadoro (cORR), ọnụego njikwa ọrịa (DCR), na nchekwa.
Nsonaazụ:
Mgbe e mechara data (Ọktoba 24, 2024), e kenyere 494 pts (T-DXd, n = 246; RAM + PTX, n = 248). Dabere na ihe omume OS 266 a hụrụ (nkebi ozi = 78.5%), e nwetara ọkwa arụmọrụ dị elu (P < 0.0228). Nlele OS etiti (m) (95% CI) bụ 16.8 mo (14.0-20.0) maka T-DXd na 14.4 mo (13.1-19.7) maka RAM + PTX. mOS (95% CI) bụ 14.7 mo (12.1-16.6) maka T-DXd vs 11.4 mo (9.9-15.5) maka RAM + PTX (nkebi ihe egwu [HR], 0.70; P = 0.0044). Data arụmọrụ ndị ọzọ dị na Tebụl ahụ. Oge ọgwụgwọ etiti (oke) bụ ọnwa 5.4 (0.7-30.3) na T-DXd na ọnwa 4.6 (0.9-34.9) na RAM + PTX. A kọrọ na ihe omume ndị na-adịghị mma na ọgwụgwọ (TEAEs) pụtara na 244/244 (100%) na 228/233 pts (97.9%) na T-DXd vs RAM + PTX, n'otu n'otu; 68.0% vs 73.8% bụ ọkwa (G) ≥3. TEAE siri ike nwere T-DXd vs RAM + PTX mere na 41.0% vs 43.3% nke pts; TEAE ndị metụtara ịkwụsị ọgwụ mere na 14.3% vs 17.2% nke pts. Ọrịa akpa ume/ọrịa pneumonia nke ejiri aka ya kpebie n'ihe gbasara ọgwụ mere na pasent 34 (13.9%) na T-DXd (1 G3, 0 G4/5) megide pasent 3 (1.3%) na RAM + PTX (2 G3, 1 G5).
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
Email：myimmnet@163.com
Oge ozi: Julaị-22-2025