I-Equecabtagene autoleucel (eque-cel)

I-Equecabtagene autoleucel (eque-cel), unyango lwe-T-cell oluvela kubantu oluvela kwi-B-cell maturation antigen-targeting chimeric antigen receptor (CAR), lubonakalise amandla okunyanga i-relapse okanye i-refractory multiple myeloma (R/RMM).

Ngomhla wama-30 kuJuni, ngo-2023, i-National Medical Products Administration (NMPA) yaseTshayina ivumile i-New Drug Application (NDA) ye-FUCASO (Equecabtagene Autoleucel), unyango lokuqala lwe-T-cell anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) ehlabathini kunyango lwe-R/RMM olufumene imigca engaphezulu kwe-3 yonyango lwangaphambili oluqulethe ubuncinane i-proteasome inhibitor enye kunye ne-immunomodulatory agent.

Ngomhla wesi-7 kweyeNkanga, ngo-2024, i-IASO Biotherapeutics ibhengeze ukuba iziphumo zesifundo seklinikhi sesigaba se-1b/2 i-FUMANBA-1 sonyango lwayo oluchasene ngokupheleleyo ne-BCMA CAR-T ebantwini, i-Equecabtagene Autoleucel (igama lorhwebo: iFucaso™), lokunyanga i-R/RMM, zipapashwe kwijenali yezonyango ephambili i-JAMA Oncology. Olu phononongo luvavanye ukusebenza kakuhle kunye nokhuseleko lwe-Equecabtagene Autoleucel kwizigulane ezine-R/RMM ezazifumene ngaphambili imigca eyi-≥3 yonyango lwangaphambili. Iziphumo zibonise ukuba i-Equecabtagene Autoleucel ifumene izinga eliphezulu lokuphendula kunye nokuxolelwa okuhlala ixesha elide kwizigulane, kunye neprofayili yokhuseleko oluhle.

I-FUMANBA-1 luphononongo lweklinikhi olunengalo enye, oluvulelekileyo lwesigaba 1b/2 olwenziwe kumaziko ali-14 aseTshayina ukuvavanya ukusebenza kakuhle kunye nokhuseleko lwe-Equecabtagene Autoleucel kwizigulane ezine-R/RMM ezifumene imigca emi-≥3 yonyango lwangaphambili. Uvavanyo lubhalise izigulane ezine-R/RMM ezazifumene ubuncinane imigca emithathu yonyango ngaphambili, kuquka i-proteasome inhibitors kunye ne-immunomodulatory agents-based chemotherapy regimens, kwaye zazinenkqubela phambili yesifo kuluhlu lwazo lokugqibela lonyango. Izigulane ezazifumene unyango lwe-BCMA CAR-T ngaphambili nazo zazifanelekile ukubhaliswa.

IziphumoKwizigulane ezili-103 ezafumana i-eque-cel infusion, ezingama-55 (53.4%) yayingamadoda, kwaye ubudala obuphakathi (uluhlu) yayiyiminyaka engama-58 (39-70). Kwi-median (uluhlu) yokulandelela iinyanga ezili-13.8 (0.4-27.2), Ngokuphathelele ukusebenza kakuhle, phakathi kwezigulane ezili-101 ezivavanyiweyo, izinga lokuphendula lilonke (ORR) yayiyi-96.0% (97/101), kwaye izinga lokuphendula liphelele (sCR/CR) eliqinileyo yayiyi-74.3% (75/101). Phakathi kwezigulane ezingama-89 ezazingenalo unyango lwe-CAR-T ngaphambili, i-ORR yayiyi-98.9% (88/89), kwaye izinga le-sCR/CR yayiyi-78.7% (70/89). Kwezi zigulana zili-101, ixesha eliphakathi lokuphendula yayiziintsuku ezili-16 (uluhlu: 11-179), ngelixa ixesha eliphakathi lokuphendula (DOR) kunye nexesha eliphakathi lokusinda ngaphandle kokuqhubela phambili (PFS) lalingekafikelelwa. Izinga le-PFS leenyanga ezili-12 laliyi-78.8% (95% CI: 68.6-86.0). Ukongeza, ama-95% (96/101) ezigulana afumene ukungabikho kwe-MRD (MRD) okuncinci, kunye nexesha eliphakathi lokungabikho kwe-MRD leentsuku ezili-15 (uluhlu: 14-186). Zonke izigulana ezine-sCR/CR zifumene ukungabikho kwe-MRD, kwaye ixesha eliphakathi lokungabikho kwe-MRD akukafikelelwa.

Izigqibo kunye noBuchuleKolu vavanyo, i-eque-cel ikhokelele kwiimpendulo zakuqala, ezinzulu, nezihlala ixesha elide kwizigulane ezine-R/RMM ephathwe kwangaphambili kakhulu eneprofayili yokhuseleko elawulekayo. Izigulane ezazinonyango lwe-CAR T-cell ngaphambili nazo zixhamle kwi-eque-cel.

Okwangoku, kukho ezinye iimvavanyo ezininzi zeklinikhi ze-CAR-T eTshayina, kwaye zikhangela izigulane. Ukuze ufumane iingcebiso ngamayeza amatsha kunye netekhnoloji, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

Inombolo yefowuni: 4008803716

Email：myimmnet@163.com

Iireferensi

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