Ku ya 21 Werurwe 2025, Junshi Biosciences yatangaje ko Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (“NMPA”) cyemeje ikoreshwa ry’umuti mushya (“sNDA”) ku muti w’ikigo, toripalimab, hamwe na bevacizumab mu kuvura abarwayi ba kanseri y’umwijima idakira cyangwa ikwirakwira mu maraso (“HCC”).
Kwemezwa kw'inyongera kwa NDA gushingiye ku makuru yavuye mu bushakashatsi bwa HEPATORCH (NCT04723004), bukaba ari ubushakashatsi mpuzamahanga bw'ubuvuzi bukorwa mu byiciro byinshi, bukozwe mu buryo butaziguye, bufunguye, kandi bugenzurwa mu cyiciro cya 3. Porofeseri Jia FAN, umuhanga mu by'ubumenyi bw'Abashinwa, ukomoka mu bitaro bya Zhongshan ishamikiye kuri Kaminuza ya Fudan, yabaye umushakashatsi mukuru. HEPATORCH yatangijwe mu bigo 57 by'ubuvuzi mu Bushinwa, Tayiwani na Singapuru mu Bushinwa, kandi abarwayi 326 bose hamwe bariyandikishije. Ubu bushakashatsi bwari bugamije gusuzuma imikorere n'umutekano wa toripalimab hamwe na bevacizumab mu kuvura HCC idakira cyangwa yanduye ugereranije n'ubuvuzi busanzwe butangwa na sorafenib.
Muri Nzeri 2024, ibyavuye mu bushakashatsi bwa HEPATORCH byagaragaye ku nshuro ya mbere mu nama ya 27 y’igihugu y’ubuvuzi bwa kanseri n’inama ngarukamwaka y’ubushakashatsi bw’umuryango w’abashinwa bavura kanseri (CSCO) yo mu 2024. Ibyavuye mu bushakashatsi byagaragaje ko iherezo ry’ibanze, kubaho nta guhindagurika (“PFS,” hashingiwe ku isuzuma ryigenga rya radiyo) na OS, byombi byabonye umusaruro mwiza.
HEPATORCH yagaragaje ko ugereranije na sorafenib, toripalimab hamwe na bevacizumab bishobora kongera cyane PFS na OS y'abarwayi, hamwe na PFS y'amezi 5.8 ugereranije n'amezi 4.0, bigabanya ibyago byo kwiyongera k'indwara cyangwa urupfu ku kigero cya 31% (igipimo cy'ibyago [HR] = 0.69, 95% CI: 0.525-0.913; P = 0.0086), hamwe na OS y'amezi 20.0 ugereranyije n'amezi 14.5, kandi bigabanya ibyago byo gupfa ku kigero cya 24% (HR = 0.76, 95% CI: 0.579-0.987; P = 0.0394). Igipimo cy'ubwitabire ("ORR") cy'itsinda rya toripalimab na bevacizumab cyari hejuru cyane ugereranyije n'itsinda rya sorafenib. ORR y'itsinda yombi yari 25.3% na 6.1%, uko bikurikirana. Byongeye kandi, uburyo bwo kuvura buvanze bufite umutekano mwiza ku barwayi bafite HCC iteye imbere. Uburyo bwo kuvura bujyanye n'uburyo busanzwe bwo kuvura bujyanye n'uburyo busanzwe bwo kuvura, kandi nta kimenyetso gishya cy'umutekano cyagaragaye.
Ibyerekeye Toripalimab
Toripalimab ni antibody ya monoclonal anti-PD-1 yakozwe kubera ubushobozi bwayo bwo guhagarika imikoranire ya PD-1 na ligands zayo, PD-L1 na PD-L2, no gutuma PD-1 receptor internalization (imikorere ya endocytosis). Kubuza imikoranire ya PD-1 na PD-L1 na PD-L2 bitera imbaraga ubudahangarwa bw'umubiri bwo kwibasira no kwica uturemangingo twa kanseri.
Inyigo zisaga mirongo ine za toripalimab ziterwa inkunga n’ibigo zigaragaza ibimenyetso birenga cumi na bitanu zakozwe ku isi hose na Junshi Biosciences, harimo no mu Bushinwa, Leta Zunze Ubumwe za Amerika, i Burayi no mu majyepfo y’uburasirazuba bwa Aziya. Igerageza rikomeje cyangwa ryarangiye ry’ingenzi risuzuma umutekano n’ubushobozi bwa toripalimab rikubiyemo ubwoko bwinshi bw’ibibyimba, harimo kanseri y’ibihaha, iz’impyiko, iz’umuyoboro w’amaraso, iz’igifu, iz’uruhago, iz’ibere, iz’umwijima, iz’impyiko n’iz’uruhu.
Mu gihugu cy'Ubushinwa, toripalimab ni yo antibody ya mbere yo mu gihugu irwanya PD-1 monoclonal yemejwe kugurishwa (yemejwe mu Bushinwa nka TUOYI®). Kuri ubu, hari ibimenyetso cumi na kimwe byemewe bya toripalimab mu gihugu cy'Ubushinwa:
melanoma idakira cyangwa yanduye nyuma yo kunanirwa kuvura indwara isanzwe;
kanseri yo mu nda isubira cyangwa itera kanseri y’imitsi (NPC) nyuma yo kunanirwa nibura imirongo ibiri yabanje yo kuvura umubiri;
kanseri y’umura yateye imbere cyangwa ya metastatic yo mu gace runaka yananiwe gukoresha imiti ya platine cyangwa yageze mu mezi 12 nyuma yo guhabwa imiti ya platine ya neoadjuvant cyangwa adjuvant;
hamwe na cisplatin na gemcitabine nk'uburyo bwa mbere bwo kuvura abarwayi bafite NPC isubira inyuma cyangwa ikwirakwira mu gace runaka;
hamwe na paclitaxel na cisplatin mu kuvura abarwayi ba kanseri y’uturemangingo tudasanzwe cyangwa tudashobora kuvurwa mu buryo burambye (ESCC);
hamwe na pemetrexed na platinum nk'uburyo bwa mbere bwo kuvura kanseri y'ibihaha ya EGFR mutation-negative na ALK mutation-negative, idakira, yateye imbere cyangwa yateye kanseri y'ibihaha itari squamous non-small cell (NSCLC);
hamwe na chimiotherapie nk'ubuvuzi bwo mu gihe cyo kubagwa hanyuma na monotherapy nk'ubuvuzi bwunganira ku kuvura abarwayi bakuru bafite icyiciro cya IIIA-IIIB NSCLC gishobora kuvurwa;
hamwe na axitinib mu kuvura ku rwego rwa mbere abarwayi bafite kanseri y'impyiko idashobora kuvurwa cyangwa kanseri y'impyiko ya metastatic (RCC) ifite ibyago biri hagati kugeza kuri byinshi;
hamwe na etoposide hamwe na platine mu kuvura kanseri y'ibihaha mu cyiciro cya mbere (ES-SCLC);
hamwe na paclitaxel yo guterwa inshinge (ibound albumin) mu kuvura kanseri y'ibere ya triple-negative isubira inyuma cyangwa ikwirakwira mu maraso (TNBC);
hamwe na bevacizumab mu kuvura indwara ya mbere y’abarwayi ba kanseri y’umwijima idakira cyangwa iterwa n’imitsi (HCC).
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
Igihe cyo kohereza: Werurwe-27-2025