Ngomhlaka-31 Disemba, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-VYLOYTM (zolbetuximab), kanye ne-fluoropyrimidine- kanye ne-platinum-containing chemotherapy, yokwelashwa kokuqala kweziguli ezine-adenocarcinoma ye-human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma enama-tumors angu-claudin (CLDN) 18.2 positive. I-Zolbetuximab iyi-antibody yokuqala ye-monoclonal evunyelwe yi-NMPA ukuhlosa amaseli esimila esiswini aveza i-biomarker ye-CLDN18.2, enikeza indlela eqondiswe kakhulu ekwelashweni komdlavuza.
Ukuvunyelwa kwe-NMPA kwe-zolbetuximab kusekelwa idatha evela ezivivinyweni zezokwelapha zeSigaba sesi-3 se-GLOW kanye ne-SPOTLIGHT ezazihlanganisa iziguli ezingu-145 kanye nezingu-36 ezivela ezwenikazi laseShayina, ngokulandelana. Isivivinyo se-GLOW sihlole i-zolbetuximab kanye ne-CAPOX (uhlelo lwe-chemotherapy oluhlanganisiwe oluhlanganisa i-capecitabine kanye ne-oxaliplatin) uma kuqhathaniswa ne-placebo kanye ne-CAPOX. Isivivinyo se-SPOTLIGHT sihlole i-zolbetuximab kanye ne-mFOLFOX6 (uhlelo lwe-combination oluhlanganisa i-oxaliplatin, i-leucovorin kanye ne-fluorouracil) uma kuqhathaniswa ne-placebo kanye ne-mFOLFOX6.
Isivivinyo se-SPOTLIGHT sihlole i-zolbetuximab kanye ne-mFOLFOX6 (uhlelo oluhlanganisiwe oluhlanganisa i-oxaliplatin, i-leucovorin kanye ne-fluorouracil) uma kuqhathaniswa ne-placebo kanye ne-mFOLFOX6. Ukwelashwa nge-zolbetuximab kuboniswe ukuthi kuhlinzeka ngentuthuko ebalulekile ngokwezibalo ekusindeni okungenawo ama-progression-free (PFS) kanye nokusinda okuphelele (OS) uma kuqhathaniswa nezinye izindlela zokwelapha ngamakhemikhali ezijwayelekile ezigulini ezifanelekile ezinomdlavuza wesisu kanye ne-GEJ. Esivivinyweni se-GLOW, i-PFS ephakathi kwezinyanga ezingu-8.21 yafezwa nge-zolbetuximab kanye ne-CAPOX njengokwelashwa kokuqala uma kuqhathaniswa nezinyanga ezingu-6.80 nge-placebo kanye ne-CAPOX. I-OS ephakathi yayizinyanga ezingu-14.39 uma kuqhathaniswa nezinyanga ezingu-12.16 emaqenjini okwelashwa afanele. Imiphumela efanayo yokusebenza kahle ibonwe esivivinyweni se-SPOTLIGHT, lapho i-PFS ephakathi yayizinyanga ezingu-10.61 uma kuqhathaniswa nezinyanga ezingu-8.67, kanti i-OS ephakathi yayizinyanga ezingu-18.23 uma kuqhathaniswa nezinyanga ezingu-15.54, ne-zolbetuximab kanye ne-mFOLFOX6, uma kuqhathaniswa ne-placebo kanye ne-mFOLFOX6. Kuzo zombili izivivinyo ze-GLOW kanye ne-SPOTLIGHT, izehlakalo zezehlakalo ezimbi eziphuthumayo zokwelashwa (ama-TEAE) zazifana emaqenjini okwelashwa kwe-zolbetuximab uma kuqhathaniswa nezilawuli. Ama-TEAE ajwayelekile kakhulu abikwe emaqenjini okwelashwa kwe-zolbetuximab kwakuwukucasuka, ukuhlanza kanye nokuncipha kwesifiso sokudla.
Ekuhlaziyweni okuhlangene, ukusinda okuphakathi nendawo okungenalo ukuqhubekela phambili kwakuyizinyanga ezingu-9.2 eqenjini le-zolbetuximab kanye nezinyanga ezingu-8.2 eqenjini le-placebo (isilinganiso sengozi yokuqhubekela phambili noma yokufa, u-0.71; isikhawu sokuzethemba esingu-95% [CI], u-0.61 kuya ku-0.83). Iziguli ezingu-377 kwezingu-537 (70.2%) eqenjini le-zolbetuximab kanye neziguli ezingu-424 kwezingu-535 (79.3%) eqenjini le-placebo zafa. Ukusinda okuphakathi nendawo kwakuyizinyanga ezingu-16.4 eqenjini le-zolbetuximab kanye nezinyanga ezingu-13.7 eqenjini le-placebo (isilinganiso sengozi yokufa, u-0.77; u-95% CI, u-0.67 kuya ku-0.89). Izinhlobo zokwelapha umdlavuza ezalandela zazilinganiselwe phakathi kwamaqembu okwelashwa.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Jan-09-2025