Equecabtagene autoleucel (eque-cel)

Equecabtagene autoleucel (eque-cel), chithandizo cha maselo a T-cell opangidwa ndi anthu chochokera ku B-cell maturation antigen-targeting chimeric antigen receptor (CAR), chawonetsa kuthekera kochizira matenda a relapse or refractory multiple myeloma (R/RMM).

Pa June 30, 2023, bungwe la National Medical Products Administration (NMPA) la ku China lavomereza New Drug Application (NDA) ya FUCASO (Equecabtagene Autoleucel), chithandizo choyamba padziko lonse cha anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell chochizira R/RMM chomwe chinalandira njira ≥3 za mankhwala am'mbuyomu omwe anali ndi proteasome inhibitor imodzi komanso immunomodulatory agent.

Pa Novembala 07, 2024, IASO Biotherapeutics idalengeza kuti zotsatira za kafukufuku wachipatala wa gawo la 1b/2 wa FUMANBA-1 wa chithandizo chake chothana ndi BCMA CAR-T mwa anthu, Equecabtagene Autoleucel (dzina lamalonda: Fucaso™), chochizira R/RMM, zasindikizidwa mu magazini yotchuka ya zamankhwala ya JAMA Oncology. Kafukufukuyu adawunika momwe Equecabtagene Autoleucel imagwirira ntchito komanso momwe imatetezera odwala omwe ali ndi R/RMM omwe adalandira kale njira ≥3 za chithandizo chakale. Zotsatira zake zidawonetsa kuti Equecabtagene Autoleucel idapeza chiwopsezo chachikulu cha kuyankha komanso kuchira kokhazikika kwa odwala, omwe ali ndi mbiri yabwino yotetezeka.

FUMANBA-1 ndi kafukufuku wachipatala wolembetsa wa gawo limodzi, lotseguka la 1b/2 lomwe linachitika m'malo 14 aku China kuti awone momwe Equecabtagene Autoleucel imagwirira ntchito komanso chitetezo chake mwa odwala omwe ali ndi R/RMM omwe adalandira njira zochiritsira zakale ≥3. Kafukufukuyu adalembetsa odwala omwe ali ndi R/RMM omwe adalandira njira zosachepera zitatu zothandizira, kuphatikizapo proteasome inhibitors ndi mankhwala a chemotherapy omwe amapangidwa ndi immunomodulatory agents, ndipo matenda adakula pa njira yawo yomaliza yothandizira. Odwala omwe adalandira chithandizo cha BCMA CAR-T kale anali oyenereranso kulembetsa.

ZotsatiraMwa odwala 103 omwe adalandira eque-cel infusion, 55 (53.4%) anali amuna, ndipo zaka zapakati (zosiyanasiyana) zinali zaka 58 (39-70). Pa kafukufuku wapakati (zosiyanasiyana) wa miyezi 13.8 (0.4-27.2), Ponena za mphamvu, pakati pa odwala 101 omwe adayesedwa, kuchuluka kwa mayankho onse (ORR) kunali 96.0% (97/101), ndipo kuchuluka kwa mayankho okwanira (sCR/CR) kunali 74.3% (75/101). Pakati pa odwala 89 omwe sanalandire chithandizo cha CAR-T, ORR inali 98.9% (88/89), ndipo kuchuluka kwa sCR/CR kunali 78.7% (70/89). Mwa odwala 101 awa, nthawi yapakati yoti ayankhe inali masiku 16 (kuyambira: 11-179), pomwe nthawi yapakati yoyankha (DOR) ndi nthawi yapakati yopulumuka yopanda kupitirira (PFS) inali isanakwaniritsidwe. Chiŵerengero cha PFS cha miyezi 12 chinali 78.8% (95% CI: 68.6-86.0). Kuphatikiza apo, 95% (96/101) ya odwala adapeza negativity yochepa yotsalira matenda (MRD), ndi nthawi yapakati yotsala ku MRD ya masiku 15 (kuyambira: 14-186). Odwala onse omwe ali ndi sCR/CR adapeza negativity ya MRD, ndipo nthawi yapakati yolakwika ya MRD sinakwaniritsidwe.

Mapeto ndi Kufunika KwakeMu kafukufukuyu, eque-cell inatsogolera ku mayankho oyambirira, akuya, komanso okhazikika mwa odwala omwe anali ndi R/RMM yothandizidwa kale komanso chitetezo chodalirika. Odwala omwe anali ndi chithandizo cha CAR T-cell kale adapindulanso ndi eque-cel.

Pakadali pano, pali mayeso ena ambiri azachipatala a CAR-T ku China, ndipo akufunafuna odwala. Kuti mumve zambiri za mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

Nambala ya Foni: 4008803716

Email：myimmnet@163.com

Zolemba

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