Ulawulo lweMveliso yezonyango yeSizwe yaseTshayina (i-NMPA) luVumela i-VYLOYTM (zolbetuximab) yoNyango lokuQala lwe-Advanced Gastric okanye i-Gastroesophageal Junction Adenocarcinoma

Ngomhla wama-31 kuDisemba, i-National Medical Products Administration (NMPA) yaseTshayina ivumile i-VYLOYTM (zolbetuximab), kunye ne-fluoropyrimidine kunye ne-platinum-containing chemotherapy, kunyango lokuqala lwezigulane ezine-advanced local unresectable okanye metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma ene-tumor ene-claudin (CLDN) 18.2 positive. I-Zolbetuximab yi-antibody yokuqala ye-monoclonal evunyiweyo yi-NMPA ukujolisa kwiiseli ze-tumor zesisu ezibonisa i-biomarker ye-CLDN18.2, enika indlela ejolise kakhulu kunyango lomhlaza.

Ukuvunywa kwe-NMPA kwe-zolbetuximab kuxhaswa yidatha evela kuvavanyo lweklinikhi lweSigaba sesi-3 se-GLOW kunye ne-SPOTLIGHT oluquka izigulane ezili-145 kunye nama-36 ezivela kwilizwekazi laseTshayina, ngokwahlukeneyo. Uvavanyo lwe-GLOW luvavanye i-zolbetuximab kunye ne-CAPOX (unyango lwe-chemotherapy oludibeneyo oluquka i-capecitabine kunye ne-oxaliplatin) xa kuthelekiswa ne-placebo kunye ne-CAPOX. Uvavanyo lwe-SPOTLIGHT luvavanye i-zolbetuximab kunye ne-mFOLFOX6 (unyango oludibeneyo oluquka i-oxaliplatin, i-leucovorin kunye ne-fluorouracil) xa kuthelekiswa ne-placebo kunye ne-mFOLFOX6.

Uvavanyo lwe-SPOTLIGHT luvavanye i-zolbetuximab kunye ne-mFOLFOX6 (unyango oludibeneyo oluquka i-oxaliplatin, i-leucovorin kunye ne-fluorouracil) xa kuthelekiswa ne-placebo kunye ne-mFOLFOX6. Unyango nge-zolbetuximab luboniswe ukuba lubonelela ngophuculo olubalulekileyo kwi-progression-free survival (PFS) kunye ne-overall survival (OS) xa kuthelekiswa nezinye iindlela zonyango ezisemgangathweni kwizigulane ezifanelekileyo ezine-gastric cancer kunye ne-GEJ. Kuvavanyo lwe-GLOW, i-PFS ephakathi yeenyanga eziyi-8.21 yafezekiswa nge-zolbetuximab kunye ne-CAPOX njengonyango lokuqala xa kuthelekiswa neenyanga eziyi-6.80 nge-placebo kunye ne-CAPOX. I-OS ephakathi yayiziinyanga ezili-14.39 xa kuthelekiswa neenyanga ezili-12.16 kumaqela onyango ahlukeneyo. Iziphumo ezifanayo zokusebenza zibonwe kuvavanyo lwe-SPOTLIGHT, apho i-PFS ephakathi yayiziinyanga ezili-10.61 xa kuthelekiswa neenyanga ezili-8.67, kwaye i-OS ephakathi yayiziinyanga ezili-18.23 xa kuthelekiswa neenyanga ezili-15.54, kunye ne-zolbetuximab kunye ne-mFOLFOX6, xa kuthelekiswa ne-placebo kunye ne-mFOLFOX6. Kuzo zombini iimvavanyo ze-GLOW kunye ne-SPOTLIGHT, iziganeko zeziganeko ezibi ezingxamisekileyo zonyango (ii-TEAE) zazifana kumaqela onyango lwe-zolbetuximab xa kuthelekiswa namaqela olawulo. Ezona TEAE zixhaphakileyo ezichazwe kumaqela onyango lwe-zolbetuximab yayikukucaphuka, ukuhlanza kunye nokuncipha kokutya.

Kuhlalutyo oludibeneyo, ukusinda okuphakathi kokungabikho kokuqhubela phambili bekuziinyanga eziyi-9.2 kwiqela le-zolbetuximab kunye neenyanga eziyi-8.2 kwiqela le-placebo (umlinganiselo wengozi yokuqhubela phambili okanye ukufa, 0.71; 95% isithuba sokuzithemba [CI], 0.61 ukuya ku-0.83). Inani lilonke labaguli abangama-377 kwabangama-537 (70.2%) kwiqela le-zolbetuximab kunye nabaguli abangama-424 kwabangama-535 (79.3%) kwiqela le-placebo bafa. Umlinganiselo wokusinda uwonke ubuziinyanga ezili-16.4 kwiqela le-zolbetuximab kunye neenyanga ezili-13.7 kwiqela le-placebo (umlinganiselo wengozi yokufa, 0.77; 95% CI, 0.67 ukuya ku-0.89). Iintlobo zonyango olulandelayo lokulwa nomhlaza bezilinganisiwe phakathi kwamaqela onyango.

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

IIREFERENSI

1.国家药监局批准注射用佐妥昔单抗上市 (nmpa.gov.cn)

2.I-Zolbetuximab kunye ne-CAPOX kwi-CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: uvavanyo lwe-GLOW lwesigaba sesi-3 olungacwangciswanga | I-Nature Medicine

3.I-Zolbetuximab kwi-Adenocarcinoma yeGastric okanye yeGastroesophageal Junction | Ijenali yezonyango yaseNew England (nejm.org)

4.I-Zolbetuximab kunye ne-mFOLFOX6 kwizigulane ezine-CLDN18.2-positive, HER2-negative, ezinganyangwanga, eziphuculweyo apha ekhaya okanye ezisasazekayo kwisisu okanye kwi-gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): uvavanyo lwesigaba sesi-3 oluneziko ezininzi, olucwangcisiweyo, olungaboni kabini, - I-Lancet