I-TEVIMBRA Ivunyelwe e-US Ukwelashwa Kokuqala Kwe-Advanced Esophageal Squamous Cell Carcinoma Ngokuhlanganiswa Ne-Chemotherapy

NgoMashi 4, 2025, i-BeiGene yamemezela ukuthi i-US Food and Drug Administration (FDA) ivumile i-TEVIMBRA(tislelizumab-jsgr), kanye ne-chemotherapy equkethe i-platinum, yokwelashwa kokuqala kwabantu abadala abane-carcinoma ye-squamous cell carcinoma (ESCC) engasuswa noma esakazeka kalula lapho izimila zazo ziveza i-PD-L1 (≥1).

Isibonakaliso esengeziwe sisekelwe emiphumeleni evela ku-RATIONALE-306 ka-BeiGene (I-NCT03783442), ucwaningo lweSigaba sesi-3 lomhlaba wonke olungahleliwe, olulawulwa yi-placebo, olungaboni kabili, lokuhlola ukusebenza kahle kanye nokuphepha kwe-TEVIMBRA ngokuhlanganiswa ne-chemotherapy equkethe i-platinum njengokwelashwa kokuqala ezigulini ezindala (n=649) nge-ESCC engasuswa, ethuthukisiwe endaweni noma ephindaphindayo. Ucwaningo luhlangabezane nephuzu lalo eliyinhloko futhi lwabonisa ukuthuthuka okuphawulekayo ngokwezibalo ekusindeni okuphelele (OS) kweziguli ezindala ezithathwe ngokungahleliwe ku-TEVIMBRA ngokuhlanganiswa ne-chemotherapy uma kuqhathaniswa ne-placebo ngokuhlanganiswa ne-chemotherapy. Ukuhlaziywa kokuhlola kubonise ukuthi ukuthuthuka kwabantu abahlose ukwelapha (ITT) kubangelwa kakhulu yimiphumela ebonwe eqenjini elincane leziguli ezine-PD-L1 ≥1. Ukuhlaziywa kwe-OS kubantu abane-PD-L1 positive (≥1) (n=481) kubonise i-OS ephakathi kwezinyanga ezingu-16.8 ezigulini eziphathwe nge-TEVIMBRA kanye ne-chemotherapy uma kuqhathaniswa nezinyanga ezingu-9.6 ezigulini eziphathwe nge-placebo kanye ne-chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), okuholele ekunciphiseni okungu-34% kwengozi yokufa. Le miphumela imelela ukuthuthuka okungakaze kubonwe ku-OS ezigulini ze-ESCC zomugqa wokuqala.

Mayelana ne-TEVIMBRA (tislelizumab-jsgr)®

I-TEVIMBRA iyi-antibody ye-immunoglobulin G4 (IgG4) eklanyelwe ngendlela ehlukile yokulwa nohlelo lokufa kweseli 1 (PD-1) ene-affinity ephezulu kanye nokucaciswa kokubopha ngokumelene ne-PD-1. Yenzelwe ukunciphisa ukubopha kuma-receptor e-Fc-gamma (Fcγ) kuma-macrophages, okusiza amangqamuzana omzimba ukuthi athole futhi alwe nezimila.

Mayelana ne-Esophageal Squamous Cell Carcinoma (ESCC)

Emhlabeni jikelele, umdlavuza we-esophageal uyimbangela yesithupha evame kakhulu yokufa okuhlobene nomdlavuza, kanti i-ESCC iyinhlobo ye-histologic evame kakhulu, ebangela cishe u-90% womdlavuza we-esophageal. Kulinganiselwa ukuthi amacala amasha omdlavuza we-esophageal angu-957,000 aqagelwa ngo-2040, ukwanda cishe ngo-60% kusukela ngo-2020, okugcizelela isidingo sokwelashwa okwengeziwe okusebenzayo.1 Umdlavuza we-esophageal uyisifo esibulalayo ngokushesha, futhi iziguli ezingaphezu kwezingxenye ezimbili kwezintathu zinezifo ezithuthukile noma ezisakazekile ngesikhathi sokuxilongwa, kanye nesilinganiso sokusinda seminyaka emihlanu esilindelekile esingaphansi kuka-6% kulabo abane-metastases ekude.

I-TEVIMBRA nayo ivunyelwe e-US njengokwelashwa okukodwa kokwelapha iziguli ezindala ezine-carcinoma ye-squamous cell engasuswa noma esakazeka kalula ngemuva kwe-chemotherapy yangaphambilini eyayingafaki i-PD-(L)1 inhibitor futhi ihlanganiswe ne-chemotherapy yokwelashwa kokuqala kwabantu abadala abanomdlavuza wesisu kanye ne-gastroesophageal junction (G/GEJ).

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.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

1.国家药品监督管理局 (nmpa.gov.cn)

2.百济神州 | 癌症没有国界。我們也沒有。 (beigene.com)