Tagitanlimab yemerewe kuvura ku rwego rwa mbere hamwe na cisplatin na gemcitabine ku barwayi ba kanseri yo mu nda isubira cyangwa yanduye.

Ku itariki ya 20 Mutarama, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) cyemeye umuti mushya w’ubudahangarwa bwa monoclonal tagitanlimab(yahoze ari KL-A167) Uburyo bwo kuvura cisplatin na gemcitabine mu buryo bwa mbere bwo kuvura abarwayi ba kanseri yo mu nda isubira cyangwa ikwirakwira mu mihogo (NPC).

Iki ni ikimenyetso cya kabiri cyemewe kuri Tagolizumab. Mbere yaho, NMPA yemeje ko mu Bushinwa hakoreshwa tagitanlimab monotherapy mu kuvura abarwayi bafite NPC isubira cyangwa isanzwe yangiritse nyuma yo guhabwa imiti ya 2L+.

Kwemeza gushingiye ku bushakashatsi bwakozwe ku rwego rwo hejuru, bwakozwe ku buryo butaziguye, bugenzurwa na placebo, bugizwe n’ibigo byinshi, busuzuma ingaruka nziza n’umutekano bya tagitanlimab hamwe na cisplatin na gemcitabine ugereranije na placebo hamwe na cisplatin na gemcitabine mu kuvura NPC isubira cyangwa ihinduka, bwayobowe na Porofeseri Shi Yuankai wo mu bitaro bya Cancer Hospital Chinese Academy of Medical Sciences nk’umushakashatsi mukuru.

Dukurikije ibyavuye mu bushakashatsi, tagitanlimab ikoreshwa hamwe na cisplatin na gemcitabine mu kuvura indwara ya NPC isubira cyangwa ihinduka ishobora kugira ubuzima bwiza butagira progression-free survival (PFS), igipimo cyo hejuru cy’ingaruka zifatika (ORR) ndetse n’igihe kirekire cyo gusubiza (DoR) ugereranije na chemotherapy, aho abarwayi bose bashobora kungukirwa hatitawe ku mikorere ya PD-L1. Igipimo cya PFS gikoreshwa kuri tagitanlimab hamwe na chemotherapy ntikigerwaho ugereranije n’amezi 7.9 kuri placebo hamwe na chemotherapy, kandi ibyago byo kwiyongera kw’indwara n’urupfu bigabanukaho 53%; ORR ni 81.7% ugereranije na 74.5%; igipimo cya DoR gikoreshwa hagati ni 11.7 ugereranije na 5.8, byikubye hafi kabiri ugereranije na placebo arm; ubu igipimo cy’ubuzima rusange (OS) ntikiragera, ariko inyungu kuri OS ya tagitanlimab hamwe na chemotherapy yamaze kugaragara, kandi ibyago byo gupfa biragabanukaho 38%. Tagitanlimab kandi yagaragaje umutekano uhamye.

Ku bijyanye na NPC

Imibare ya GLOBOCAN yo mu 2022 yagaragaje ko hari abantu barenga 120.000 barwaye kanseri yo mu nda ku isi, abantu bashya 51.000 barwaye kanseri yo mu nda n'impfu 28.400 mu Bushinwa. Dukurikije amabwiriza ya CSCO yo mu 2021, uburyo bwo kuvura kanseri yo mu nda ya 1L idakira cyangwa ivurwa mu gace runaka bushingiye ku miti ivanze irimo platine, naho ubuvuzi bwa 2L bushingiye ku buvuzi bumwe. Igipimo cy'ubuzima bw'abarwayi barwaye kanseri yo mu nda ya 1L isubira cyangwa ivurwa mu maraso ni 18.5%, aho ikigereranyo cy'amezi 22.1, kandi haracyakenewe ko habaho kunoza inyungu z'itsinda ry'abarwayi, cyane cyane abarwara kanseri nyuma yo kuvurwa. Mu myaka ya vuba aha, ubuvuzi bw'ubudahangarwa bw'umubiri bwatanze uburyo bwinshi bwo kuvura abarwayi ba kanseri kandi bwabaye uburyo bwiza bwo kuvura abarwayi ba kanseri yo mu nda.

Ibyerekeye Tagitanlima

Tagitanlima, yakozwe na Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, Ubushinwa), ni antibody ya IgG1κ monoclonal yuzuye igamije kurwanya PD-L1 ibuza imikoranire ya PD-L1 na PD-1.

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

Imeri:myimmnet@163.com

Amareferensi

1.国家药品监督管理局 (nmpa.gov.cn)

2.Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.