TEVIMBRA Yemejwe muri Amerika mu kuvura kanseri y’inkari yo mu nda iteye imbere mu buryo bwa "esophageal Squamous Cell Carcinoma" ivanze na Chimotherapie.

Ku ya 4 Werurwe 2025, BeiGene yatangaje ko Ikigo gishinzwe Ibiribwa n'Imiti muri Amerika (FDA) cyemeje TEVIMBRA (tislelizumab-jsgr), hamwe na platine irimo imiti ya chimiotherapie, mu kuvura abantu bakuru bafite kanseri y’uturemangingo tudashobora kuvurwa cyangwa se kanseri y’uturemangingo iterwa n’imitsi (ESCC) ifite ibibyimba bigaragara ko ari PD-L1 (≥1).

Ikindi kimenyetso gishingiye ku byavuye muri RATIONALE-306 ya BeiGene (NCT03783442), inyigo mpuzamahanga y’icyiciro cya 3, igenzurwa na placebo, idakoresha ikoranabuhanga rya double-blind, kugira ngo isuzume imikorere n’umutekano wa TEVIMBRA hamwe na platine irimo chemotherapy nk’uburyo bwa mbere bwo kuvura abarwayi bakuru (n=649) hamwe na ESCC idakira, ivuguruye cyangwa ivuguruye. Ubu bushakashatsi bwageze ku ntego yabwo y’ibanze kandi bwerekanye iterambere rikomeye mu mibare mu mibereho rusange (OS) ku barwayi bakuru bakorewe TEVIMBRA hamwe na chemotherapy ugereranije na placebo hamwe na chemotherapy. Isesengura ry’ubushakashatsi ryagaragaje ko iterambere mu baturage bagamije kuvura (ITT) ryatewe ahanini n’ibyavuye mu itsinda ry’abarwayi bafite PD-L1 ≥1. Isesengura rya OS mu baturage banduye PD-L1 (≥1) (n=481) ryagaragaje ko OS yari isanzweho mu mezi 16.8 ku barwayi bavuwe na TEVIMBRA hamwe na chimiotherapie ugereranije n'amezi 9.6 ku barwayi bavuwe na placebo hamwe na chimiotherapie (HR: 0.66, [95% CI: 0.53, 0.82]), bigatuma ibyago byo gupfa bigabanukaho 34%. Ibi bisubizo bigaragaza iterambere ridasanzwe mu OS mu barwayi ba mbere ba ESCC.

Ku bijyanye na TEVIMBRA (tislelizumab-jsgr)®

TEVIMBRA ni antibody ya immunoglobulin G4 (IgG4) yakozwe mu buryo bwihariye kandi irwanya ingirabuzimafatizo 1 (PD-1) ifite ubushobozi bwo gufatanya cyane na PD-1. Yagenewe kugabanya gufatana na za receptors za Fc-gamma (Fcγ) kuri macrophages, bigafasha uturemangingo tw’umubiri kubona no kurwanya ibibyimba.

Ku bijyanye na Kansinoma y'uturemangingo tw'umuyoboro w'amaso (ESCC)

Ku isi yose, kanseri y'umuhogo ni yo mpamvu ya gatandatu ikunze gutera impfu ziterwa na kanseri, kandi ESCC ni yo ndwara ikunze kugaragara cyane, ikaba igizwe na hafi 90% bya kanseri y'umuhogo. Mu 2040 hateganijwe ko hazabaho abarwayi bashya bagera ku 957.000 ba kanseri y'umuhogo, ikaba yiyongeraho hafi 60% ugereranije n'umwaka wa 2020, ibi bikaba bigaragaza ko hakenewe ubundi buryo bwo kuvura bunoze.1 Kanseri y'umuhogo ni indwara yica vuba, kandi abarwayi barenga bibiri bya gatatu bafite indwara ikomeye cyangwa yanduye mu gihe cyo kuyisuzuma, kandi biteganijwe ko bazabaho imyaka itanu iri munsi ya 6% ku bafite kanseri yavuye kure.

TEVIMBRA kandi yemejwe muri Amerika nk'uburyo bwo kuvura abarwayi bakuru bafite kanseri idakira cyangwa yanduye nyuma y'imiti ya kanseri isanzwe itarimo imiti igabanya ubukana bwa PD-(L)1 kandi ikanakoreshwa hamwe na chemotherapy mu kuvura abantu bakuru bafite kanseri y'igifu n'igifu (G/GEJ).

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

Nimero ya Terefone: 4008803716

Email：myimmnet@163.com

Amareferensi

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)