I-FUCASO: I-Revolutionary Fully-Human BCMA CAR-T Therapy Ngokusebenza Okungaqhathanisiwe Nokuphepha
I-FUCASO, ethuthukiswe yi-Nanjing IASO Biotechnology, iwukwelapha okudabukisayo kwe-CAR-T okuklanyelwe ngokuqondile ukukhomba i-B-cell maturation antigen (BCMA). Lokhu kwelashwa kugqama ngenxa yokusebenza kahle komtholampilo okungenakuqhathaniswa kanye nephrofayili yokuphepha, okuhlinzeka ngethemba elisha ezigulini ezine-myeloma eminingi ebuyele emuva noma ephikisayo (r/rMM). Igunyazwe i-National Medical Products Administration (NMPA) ngoJuni 30, 2023, i-FUCASO isivele ibonise impumelelo ebalulekile ezicelweni zomtholampilo.
Amazinga Okuphendula aphezulu: I-FUCASO iziqhayisa Ngezinga Lokuphendula Eliphelele (ORR) lama-98.9% kanye nezinga le-Complete Response (CR) elingu-82.4%, eliphakeme kakhulu kunezinye izindlela zokwelapha ezitholakalayo.
Ukuxolelwa Okuhlala Njalo: Iziguli ezilashwa nge-FUCASO zibonise izinga le-Progression-Free Survival (PFS) lezinyanga ezingu-12 elingu-85.5%, elibonisa ukuxolelwa kwesikhathi eside kanye nezinga lempilo elithuthukisiwe.
Iphrofayela Yokuphepha: Nge-≥3 grade Cytokine Release Syndrome (CRS) eyenzeka ku-1% kuphela weziguli futhi azikho izimo ezibikiwe ze-≥3 grade Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), i-FUCASO inikeza inketho yokwelashwa ephephile uma iqhathaniswa nezinye izindlela zokwelapha ze-CAR-T .
Izindleko-Ngempumelelo: Ukwelashwa kwe-FUCASO kubiza kakhulu ngaphansi kwezindlela zokwelapha ezifanayo ezitholakala e-United States, okuyenza ibe inketho esebenzayo kuhlu olubanzi lweziguli.
Ukufinyelela Umhlaba jikelele: I-IASO BIO isungule inethiwekhi yesikhungo sokwelapha esibanzi e-China, ekwazi ukusiza iziguli ezivela emhlabeni wonke ngamasevisi adidiyelwe kusukela ekubonisaneni kuya ekunakekelweni kwangemva kokwelashwa.
Isiguli sokuqala eselashwa nge-FUCASO sizuze iminyaka emihlanu yokuphila ngaphandle komdlavuza, okuyingqopha-mlando ephawulekayo uma kuqhathaniswa ne-Median Progression-Free Survival (PFS) yezinyanga ezingu-2.9 nje ngokunakekelwa okujwayelekile. Lokhu kugqamisa amandla e-FUCASO okuguqula isimo sokwelapha se-myeloma eminingi.