Equecabtagene autoleucel (eque-cel)

Equecabtagene autoleucel (eque-cel), uburyo bwo kuvura bwa T-cell bukomoka ku ngirabuzimafatizo za B bugamije gukura kwa antigen (CAR) bukomoka ku muntu, bwagaragaje ubushobozi bwo kuvura myeloma nyinshi (R/RMM) isubira inyuma cyangwa idashobora kugaragara.

Ku itariki ya 30 Kamena 2023, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeje Porogaramu Nshya y’Imiti (NDA) kuri FUCASO (Equecabtagene Autoleucel), ari wo muti wa mbere ku isi urwanya selile B (BCMA) utuma antigen (CAR) ikura mu mubiri w’umuntu (fully-human anti-B cell maturation antigen) mu kuvura R/RMM wahawe imirongo ≥3 y’imiti yabanje irimo nibura igabanya ubukana bwa proteasome imwe n’umuti ugabanya ubukana bw’umubiri.

Ku ya 07 Ugushyingo 2024, IASO Biotherapeutics yatangaje ko ibyavuye mu bushakashatsi bwa FUMANBA-1 mu cyiciro cya 1b/2 ku buvuzi bwayo bwa anti-BCMA CAR-T ku bantu, Equecabtagene Autoleucel (izina ry'ubucuruzi: Fucaso™), bwo kuvura R/RMM, byasohotse mu kinyamakuru gikomeye cy’ubuvuzi cyitwa JAMA Oncology. Ubushakashatsi bwasuzumye imikorere n’umutekano wa Equecabtagene Autoleucel ku barwayi barwaye R/RMM bari barahawe imirongo ≥3 y’ubuvuzi bwabanje. Ibisubizo byagaragaje ko Equecabtagene Autoleucel yagize ingaruka nziza muri rusange kandi igakomeza ku barwayi, hamwe n’umutekano mwiza.

FUMANBA-1 ni inyigo y’ubuvuzi yakozwe mu buryo bwa "single arm", ifunguye, yakozwe mu bigo 14 byo mu Bushinwa kugira ngo harebwe akamaro n’umutekano wa Equecabtagene Autoleucel ku barwayi bafite R/RMM bahawe imirongo ≥3 y’ubuvuzi bwabanje. Igerageza ryinjije abarwayi bafite R/RMM bari barahawe nibura imirongo itatu y’ubuvuzi, harimo imiti igabanya ubukana bwa proteasome n’imiti igabanya ubukana bw’umubiri ishingiye ku miti, kandi indwara zakomeje kwiyongera ku murongo wabo wa nyuma w’ubuvuzi. Abarwayi bari barahawe BCMA CAR-T na bo bari bemerewe kwiyandikisha.

IbisubizoMu barwayi 103 batewe inshinge ya eque-cel, 55 (53.4%) bari abagabo, naho imyaka yo hagati (ingana) yari 58 (39-70). Mu ikurikirana ry’amezi 13.8 (0.4-27.2), Ku bijyanye n’ubushobozi, mu barwayi 101 bapimwe, igipimo rusange cy’ubutabazi (ORR) cyari 96.0% (97/101), naho igipimo cy’ubutabazi bwuzuye (sCR/CR) cyari 74.3% (75/101). Mu barwayi 89 batabanje guhabwa ubuvuzi bwa CAR-T, ORR yari 98.9% (88/89), naho igipimo cya sCR/CR cyari 78.7% (70/89). Muri aba barwayi 101, igihe cyo gusubiza cyari iminsi 16 (intera: 11-179), mu gihe igihe cyo gusubiza (DOR) n'igihe cyo kubaho kidashingiye ku iterambere (PFS) byari bitaragera. Igipimo cya PFS cy'amezi 12 cyari 78.8% (95% CI: 68.6-86.0). Byongeye kandi, 95% (96/101) by'abarwayi bagize ikibazo gito cyo kurwara indwara (MRD), aho igihe cyo kurwara MRD cyari iminsi 15 (intera: 14-186). Abarwayi bose bafite sCR/CR bagize ikibazo cyo kurwara MRD, naho igihe cyo kurwara MRD cyari kitaragera.

Umwanzuro n'akamaroMuri iri gerageza, eque-cell yatumye abarwayi bavuwe mbere cyane na R/RMM bafite umutekano uhagije kandi bakira neza indwara ya kanseri. Abarwayi bavuwe mbere na CAR T-cell na bo bungukiye kuri eque-cel.

Kuri ubu, hari andi magerageza menshi ya CAR-T mu Bushinwa, kandi barimo gushaka abarwayi. Kugira ngo ubone inama ku miti mishya n'ikoranabuhanga, ushobora kuvugana n'Ishami Mpuzamahanga ry'Ibitaro bya Oncology bya Beijing Region South.

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Amareferensi

1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20230630195006116.html

2.https://en.iasobio.com/info.php?id=224

3. http://js.news.cn/20230926/c8e67444df624a5ea654dda3aa608689/c.html

4.https://en.iasobio.com/info.php?id=256

5.https://jamanetwork.com/journals/jamaoncology/article-abstract/2826068