I-TEVIMBRA Yamkelwe e-US kuNyango Lokuqala lwe-Advanced Esophageal Squamous Cell Carcinoma xa idityaniswe ne-Chemotherapy

Ngomhla wesi-4 kweyoKwindla, ngo-2025, iBeiGene yabhengeza ukuba i-US Food and Drug Administration (FDA) ivumile i-TEVIMBRA(tislelizumab-jsgr), kunye ne-chemotherapy equlethe iplatinum, kunyango lokuqala lwabantu abadala abane-carcinoma ye-squamous cell carcinoma (ESCC) engasuswayo okanye esasazekayo ene-metastatic esophageal (ESCC) ene-tumors eziveza i-PD-L1 (≥1).

Isalathisi esongezelelweyo sisekelwe kwiziphumo ezivela kwi-RATIONALE-306 kaBeiGene (NCT03783442), uphando lweSigaba sesi-3 olucwangcisiweyo, olulawulwa yi-placebo, olungaboni kabini, oluqhutywa kwihlabathi liphela ukuze kuvavanywe ukusebenza kakuhle kunye nokhuseleko lwe-TEVIMBRA ngokudibeneyo ne-chemotherapy equlethe iplatinum njengonyango lokuqala kwizigulane zabantu abadala (n=649) olungenakususwa, oluqhubekekayo kwindawo ethile okanye olusasazekayo. Olu phononongo lufikelele kwisiphelo salo esiphambili kwaye lubonise ukuphucuka okubalulekileyo kwi-overall survival (OS) kwizigulane zabantu abadala ezikhethwe ngokungacwangciswanga kwi-TEVIMBRA ngokudibeneyo ne-chemotherapy xa kuthelekiswa ne-placebo ngokudibeneyo ne-chemotherapy. Uhlalutyo lophando lubonise ukuba ukuphucuka kuluntu olujoliswe ekuphatheni (ITT) kubangelwa ikakhulu ziziphumo ezibonwe kwiqela elincinci lezigulane ezine-PD-L1 ≥1. Uhlalutyo lwe-OS kubantu abane-PD-L1 positive (≥1) (n=481) lubonise i-OS ephakathi yeenyanga ezili-16.8 kwizigulana ezinyangwe nge-TEVIMBRA kunye ne-chemotherapy xa kuthelekiswa neenyanga ezili-9.6 kwizigulana ezinyangwe nge-placebo kunye ne-chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), nto leyo ekhokelela ekunciphiseni umngcipheko wokufa ngama-34%. Ezi ziphumo zimele ukuphucuka okungazange kwenzeke kwi-OS kwizigulana ze-ESCC zodidi lokuqala.

Malunga ne-TEVIMBRA (tislelizumab-jsgr)®

I-TEVIMBRA yi-immunoglobulin G4 (IgG4) eyilwe ngendlela ekhethekileyo njenge-anti-programmed cell death protein 1 (PD-1) monoclonal antibody ene-affinity ephezulu kunye ne-binding specificity ngokuchasene ne-PD-1. Yenzelwe ukunciphisa ukubopha kwi-Fc-gamma (Fcγ) receptors kwi-macrophages, inceda iiseli zomzimba ukuba zibone kwaye zilwe neethumba.

Malunga ne-Esophageal Squamous Cell Carcinoma (ESCC)

Kwihlabathi liphela, umhlaza we-esophageal ngunobangela wesithandathu oxhaphakileyo wokufa okunxulumene nomhlaza, kwaye i-ESCC yeyona hlobo ixhaphakileyo ye-histologic, ebalelwa phantse kwi-90% yomhlaza we-esophageal. Kuqikelelwa ukuba kukho iimeko ezintsha zomhlaza we-esophageal ezingama-957,000 eziqikelelwayo ngo-2040, ukwanda okuphantse kube yi-60% ukusuka ngo-2020, nto leyo egxininisa isidingo sonyango olongezelelweyo olusebenzayo.1 Umhlaza we-esophageal sisifo esibulalayo ngokukhawuleza, kwaye ngaphezulu kwesibini kwisithathu sezigulane zinesifo esiqhubekekayo okanye esisasazeka ngexesha lokuxilongwa, kunye nenqanaba lokusinda elilindelekileyo leminyaka emihlanu elingaphantsi kwe-6% kwabo bane-metastases ezikude.

I-TEVIMBRA ikwavunyiwe e-US njengonyango olulodwa lokunyanga izigulane zabantu abadala ezine-carcinoma ye-squamous cell carcinoma engasuswayo okanye esasazekayo emva kwe-chemotherapy yangaphambili eyayingabandakanyi i-PD-(L)1 inhibitor kwaye idityaniswe ne-chemotherapy yonyango lokuqala lwabantu abadala abane-gastric and gastroesophageal junction (G/GEJ).

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.国家药品监督管理局 (nmpa.gov.cn)

2.百济神州 |癌症沒有国界。我們也沒有。 (beigene.com)