Nyob rau lub Cuaj Hli 27, 2022, Legendary Creatures (NASDAQ: LEGN) tshaj tawm tias Ministry of Health, Labor thiab Welfare (MHLW) ntawm Nyiv tau pom zoo CARVYKTI® (Ciltacabtagene Autoleucel, Cilta-cel) rau kev kho mob ntawm cov neeg laus cov neeg mob rov qab los. los yog refractory ntau myeloma (R/R MM). Tsuas yog ob qho xwm txheej hauv qab no tau ntsib:
Tus neeg mob tsis muaj keeb kwm ntawm chimeric antigen receptor (CAR) -positive T cell infusion targeting B-cell maturation antigen (BCMA).
Tus neeg mob tau txais tsawg kawg peb kab ntawm kev kho yav dhau los, suav nrog cov tshuaj tiv thaiv proteasome (PIs), immunomodulators (IMids), thiab anti-CD38 monoclonal antibodies, thiab tsis tau teb rau qhov kev kho mob zaum kawg lossis rov qab los.
Daim ntawv thov tshuaj tshiab tau xa los ntawm tus kws kho mob lom neeg Yangsen. Thaum Lub Kaum Ob Hlis 2017, Legendary Bio tau nkag mus rau hauv daim ntawv tso cai thoob ntiaj teb tshwj xeeb thiab kev sib cog lus nrog Yangsen los tsim thiab ua lag luam Cilta-cel.
CARVYKTI® nta ob hom tshuaj tiv thaiv ib leeg tsom rau B-cell maturation antigen (BCMA), tus kheej, thiab xa ib zaug.
Qhov kev pom zoo no yog ua raws li cov txiaj ntsig ntawm theem pivotal 1B / 2 CARTITUDE 1 txoj kev tshawb fawb, uas tau tso npe rau 97 tus neeg mob uas tau txais qhov nruab nrab ntawm rau kab ntawm kev kho yav dhau los (ntau 3-18), suav nrog PI, IMiD, thiab kev tiv thaiv. cd38 mav. Txoj kev tshawb no tau pom tias cov neeg tsis yog neeg Nyij Pooj tau txais kev kho mob ib zaug nrog cidalquiolenxil muaj cov lus teb tob thiab ruaj khov, nrog rau tag nrho cov lus teb (ORR) ntawm 96.9 feem pua (95 feem pua CI, 91.2 txog 99.4 n=97). Nco ntsoov, 65 tus neeg mob tau ua tiav cov lus teb nruj me ntsis (sCR), nrog cov lus teb nruj me ntsis ntawm 67 feem pua (95 feem pua CI, 56.7-76.2), txhais tau hais tias tsis muaj cov tsos mob lossis cov tsos mob tshwm sim. ntawm daim duab lossis lwm yam kev sim tom qab kho *. Cov txiaj ntsig tau pom nyob rau hauv cov neeg mob Nyij Pooj uas muaj ntau yam myeloma yog zoo ib yam nrog cov neeg uas tsis yog neeg Nyij Pooj. Ntawm qhov kev soj ntsuam nruab nrab ntawm 18 lub hlis, qhov nruab nrab lub sij hawm teb (DOR) yog 21.8 lub hlis.
Txoj kev tshawb fawb CARTITUDE 1 tau soj ntsuam kev nyab xeeb ntawm cedarchiolencel hauv 106 tus neeg mob laus, suav nrog 97 tus neeg tsis yog neeg Nyij Pooj thiab 9 tus neeg mob Nyij Pooj. Ntawm 106 tus neeg mob kho nrog cedarchiolencel, 105 (99.1 feem pua) muaj kev phiv tshuaj. Cov xwm txheej tsis zoo tshaj plaws suav nrog cytokine release syndrome (94.3 feem pua), cytopenia (79.2 feem pua), neutropenia (75.5 feem pua), thrombocytopenia (59.4 feem pua), anemia (51.9 feem pua), neurologic adverse events (39.6%), kab mob (19.8 feem pua) thiab hypombulinemia (11.3 feem pua) ).
Lub Ob Hlis Ntuj xyoo no, CARVYKTI® (Sidarchiolensa) tau txais kev pom zoo los ntawm US Food and Drug Administration (FDA) thiab kev tso cai ua lag luam raws cai los ntawm European Commission (EC) hauv lub Tsib Hlis.
