Thaum Lub Xya Hli 17, Lub Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tshaj tawm tias daim ntawv thov kev lag luam rau Trastuzumab Deruxtecan (Enhertu®) rau kev kho mob qog noj ntshav hauv plab kab thib ob tau raug lees txais los ntawm NMPA. Daim ntawv thov no yog rau kev kho mob rau cov neeg laus uas muaj HER2-zoo gastric lossis gastroesophageal junction adenocarcinoma hauv kab thib ob.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki hauv Tebchaws Meskas xwb) yog HER2 directed ADC. Tsim los ntawm kev siv Daiichi Sankyo's proprietary DXd ADC Technology, ENHERTU yog tus thawj coj ADC hauv oncology portfolio ntawm Daiichi Sankyo thiab yog qhov kev pab cuam siab tshaj plaws hauv AstraZeneca's ADC scientific platform. ENHERTU muaj HER2 monoclonal antibody txuas nrog ntau yam topoisomerase I inhibitor payloads (ib qho exatecan derivative, DXd) ntawm tetrapeptide-based cleavable linkers.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Daim ntawv thov teev npe no feem ntau yog raws li cov txiaj ntsig tseem ceeb ntawm kev tshawb fawb DESTINY-Gstric04 (uas tau nthuav tawm ntawm American Society of Clinical Oncology ASCO Conference xyoo 2025).
DESTINY-Gastric04 (NCT04704934), kev tshawb fawb thoob ntiaj teb, randomized, multicenter, qhib-daim ntawv lo, theem 3 ntsuam xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm T DXd vs RAM + PTX hauv pts nrog HER2 + unresectable / metastatic GC / GEJA hauv qhov chaw thib ob no.
Cov Txheej Txheem:
Tom qab kuaj pom tias muaj HER2+ (IHC 3+ lossis IHC 2+/ISH+) hauv lub cev, cov pts raug xaiv 1:1 rau T-DXd 6.4 mg/kg lossis RAM + PTX. Lub hom phiaj tseem ceeb yog kev ciaj sia tag nrho (OS). OS ntawm 2 caj npab tau muab piv los ntawm kev xeem log-rank stratified siv cov yam ntxwv randomization. Lub hom phiaj thib ob los ntawm kev ntsuam xyuas ntawm tus kws tshawb nrhiav suav nrog kev ciaj sia tsis muaj kev nce qib (PFS), tus nqi teb tau lees paub (cORR), tus nqi tswj kab mob (DCR), thiab kev nyab xeeb.
Cov txiaj ntsig:
Thaum lub sijhawm txiav cov ntaub ntawv (Lub Kaum Hli 24, 2024), muaj 494 pts tau muab (T-DXd, n = 246; RAM + PTX, n = 248). Raws li 266 qhov xwm txheej OS uas tau pom (cov ntaub ntawv feem = 78.5%), qhov ua tau zoo dua tau ua tiav (2-sided P < 0.0228). Nruab nrab (m) (95% CI) OS kev soj ntsuam yog 16.8 mo (14.0-20.0) rau T-DXd thiab 14.4 mo (13.1-19.7) rau RAM + PTX. mOS (95% CI) yog 14.7 mo (12.1-16.6) rau T-DXd vs 11.4 mo (9.9-15.5) rau RAM + PTX (qhov piv txaus ntshai [HR], 0.70; P = 0.0044). Cov ntaub ntawv ua tau zoo ntxiv nyob hauv Rooj. Lub sijhawm kho mob nruab nrab (ntau yam) yog 5.4 mo (0.7-30.3) nrog T-DXd thiab 4.6 mo (0.9-34.9) nrog RAM + PTX. Cov xwm txheej tsis zoo ntawm kev kho mob (TEAEs) tau tshaj tawm hauv 244/244 (100%) vs 228/233 pts (97.9%) nrog T-DXd vs RAM + PTX, feem; 68.0% vs 73.8% yog qib (G) ≥3. Cov TEAEs loj nrog T-DXd vs RAM + PTX tshwm sim hauv 41.0% vs 43.3% ntawm pts; TEAEs cuam tshuam nrog kev txiav tshuaj tshwm sim hauv 14.3% vs 17.2% ntawm pts. Kev txiav txim siab ywj pheej txog kev siv tshuaj uas cuam tshuam nrog kab mob ntsws interstitial/pneumonitis tau tshwm sim hauv 34 pts (13.9%) nrog T-DXd (1 G3, 0 G4/5) vs 3 pts (1.3%) nrog RAM + PTX (2 G3, 1 G5).
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
Email：myimmnet@163.com
Lub sijhawm tshaj tawm: Lub Xya Hli-22-2025