TEVIMBRA Tau Pom Zoo Hauv Tebchaws Meskas Rau Kev Kho Mob Kab Mob Cancer Esophageal Squamous Cell Carcinoma Ua Ke Nrog Kev Kho Mob Chemotherapy

Thaum Lub Peb Hlis 4, 2025, BeiGene tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo TEVIMBRA (tislelizumab-jsgr), ua ke nrog kev kho mob chemotherapy uas muaj platinum, rau kev kho mob thawj kab ntawm cov neeg laus uas muaj mob esophageal squamous cell carcinoma (ESCC) uas tsis tuaj yeem phais lossis metastatic uas cov qog nqaij hlav qhia PD-L1 (≥1).

Cov lus qhia ntxiv yog raws li cov txiaj ntsig los ntawm BeiGene's RATIONALE-306 (NCT03783442), kev tshawb fawb thoob ntiaj teb Theem 3 uas siv cov tshuaj placebo los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm TEVIMBRA ua ke nrog kev kho mob chemotherapy uas muaj platinum ua thawj kab rau cov neeg laus (n=649) uas muaj mob ESCC uas tsis tuaj yeem phais tau, mob qog nqaij hlav rov tshwm sim dua lossis mob qog nqaij hlav kis mus rau lwm qhov chaw. Kev tshawb fawb no tau ua tiav nws qhov kawg tseem ceeb thiab tau qhia txog kev txhim kho tseem ceeb hauv kev ciaj sia tag nrho (OS) rau cov neeg laus uas siv TEVIMBRA ua ke nrog kev kho mob chemotherapy piv rau placebo ua ke nrog kev kho mob chemotherapy. Kev tshuaj xyuas tshawb fawb qhia tau hais tias kev txhim kho hauv cov pej xeem uas tau txais kev kho mob (ITT) feem ntau yog vim cov txiaj ntsig pom hauv pawg neeg mob uas muaj PD-L1 ≥1. Kev tshuaj xyuas ntawm OS hauv cov pej xeem PD-L1 zoo (≥1) (n = 481) qhia tau tias OS nruab nrab ntawm 16.8 lub hlis rau cov neeg mob uas tau kho nrog TEVIMBRA ntxiv rau chemotherapy piv rau 9.6 lub hlis rau cov neeg mob uas tau kho nrog placebo ntxiv rau chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), ua rau muaj kev txo qis 34% ntawm kev pheej hmoo ntawm kev tuag. Cov txiaj ntsig no sawv cev rau kev txhim kho OS tsis tau muaj dua hauv cov neeg mob ESCC thawj kab.

Txog TEVIMBRA (tislelizumab-jsgr)®

TEVIMBRA yog ib qho tshuaj immunoglobulin G4 (IgG4) uas tsim tshwj xeeb rau tib neeg uas tiv thaiv cov hlwb tuag (cell death protein 1) (PD-1) uas muaj kev sib raug zoo thiab kev sib txuas lus tshwj xeeb tiv thaiv PD-1. Nws yog tsim los kom txo qhov kev sib txuas rau Fc-gamma (Fcγ) receptors ntawm macrophages, pab lub cev cov hlwb tiv thaiv kab mob nrhiav thiab tawm tsam cov qog nqaij hlav.

Txog Kab Mob Cancer Squamous Cell Carcinoma ntawm Esophageal (ESCC)

Thoob ntiaj teb, mob qog noj ntshav hauv txoj hlab pas yog qhov thib rau uas ua rau neeg tuag los ntawm mob qog noj ntshav, thiab ESCC yog hom mob qog noj ntshav uas feem ntau pom, uas yog ze li ntawm 90% ntawm cov mob qog noj ntshav hauv txoj hlab pas. Kwv yees li ntawm 957,000 tus neeg mob qog noj ntshav hauv txoj hlab pas tshiab yuav tshwm sim hauv xyoo 2040, uas yog qhov nce ze li ntawm 60% ntawm xyoo 2020, qhia txog qhov xav tau kev kho mob zoo ntxiv.1 Mob qog noj ntshav hauv txoj hlab pas yog ib yam kab mob uas ua rau neeg tuag taus sai heev, thiab ntau tshaj ob feem peb ntawm cov neeg mob muaj mob hnyav lossis kis mus rau lwm qhov thaum kuaj pom, nrog rau qhov feem pua ​​​​​​ntawm kev ciaj sia tsib xyoos tsawg dua 6% rau cov neeg uas kis mus rau lwm qhov deb.

TEVIMBRA kuj tau txais kev pom zoo hauv Tebchaws Meskas ua kev kho mob monotherapy rau kev kho mob rau cov neeg laus uas muaj mob qog nqaij hlav esophageal squamous cell carcinoma uas tsis tuaj yeem phais lossis kis mus rau lwm qhov tom qab kev kho mob chemotherapy yav dhau los uas tsis suav nrog PD-(L)1 inhibitor thiab ua ke nrog chemotherapy rau kev kho mob thawj kab ntawm cov neeg laus uas muaj mob qog nqaij hlav gastric thiab gastroesophageal junction (G/GEJ).

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

Cov ntaub ntawv siv los ua piv txwv

1.国家药品监督管理局 (nmpa.gov.cn)

2.百济神州 |癌症没有国界。我们也没有。 (beigene.com)