I-FUCASO: Unyango lwe-BCMA CAR-T yoMntu ngokuPheleleyo ngokuSebenza ngoKusebenza kunye noKhuseleko.
I-FUCASO, ephuhliswe yi-Nanjing IASO Biotechnology, yinkqubo yonyango ye-CAR-T eyenzelwe ngokukodwa ukujolisa i-B-cell maturation antigen (BCMA). Olu nyango luvelele ngokungenakulinganiswa kokusebenza kweklinikhi kunye neprofayili yokhuseleko, inika ithemba elitsha kwizigulane ezine-myeloma ephindaphindiweyo okanye e-refractory (r / rMM). Ivunywe yi-National Medical Products Administration (NMPA) ngoJuni 30, 2023, i-FUCASO sele ibonise impumelelo ebalulekileyo kwizicelo zeklinikhi.
Amazinga eempendulo aphezulu: I-FUCASO inezinga lokuphendula ngokubanzi (ORR) ye-98.9% kunye ne-Response Response (CR) izinga le-82.4%, liphezulu kakhulu kunezinye iindlela zonyango ezikhoyo.
Uxolelo oluhlala luhleli: Izigulane eziphathwe nge-FUCASO zibonise i-12-inyanga ye-Progression-Free Survival (PFS) ye-85.5%, ebonisa ukuxolelwa kwexesha elide kunye nokuphucula umgangatho wobomi.
Inkangeleko yoKhuseleko: Nge-≥3 ibakala le-Cytokine Release Syndrome (CRS) eyenzeka kuphela kwi-1% yezigulane kwaye akukho matyala axeliweyo ≥3 ibakala le-Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), i-FUCASO inikezela ngonyango olukhuselekileyo xa kuthelekiswa nolunye unyango lwe-CAR-T .
Iindleko-Ukusebenza: Unyango lwe-FUCASO luxabisa kakhulu ngaphantsi kweendlela zonyango ezifanayo ezifumanekayo e-United States, okwenza kube yindlela efanelekileyo yoluhlu olubanzi lwezigulane.
Ukufikeleleka kweHlabathi: I-IASO BIO iye yaseka inethiwekhi yeziko lonyango olubanzi e-China, ekwazi ukukhonza izigulane ezivela kwihlabathi jikelele kunye neenkonzo ezidibeneyo ukusuka ekuboniseni ukunakekelwa emva kokunyanga.
Isigulana sokuqala esiphathwe nge-FUCASO siphumelele iminyaka emihlanu yokuphila ngaphandle komhlaza, isiganeko esiphawulekayo xa kuthelekiswa ne-Median Progression-Free Survival (PFS) yeenyanga nje ze-2.9 ngononophelo oluqhelekileyo. Oku kuqaqambisa amandla eFUCASO okuguqula ubume bonyango lwe-myeloma ezininzi.
