Equecabtagene autoleucel (eque-cel)

Equecabtagene autoleucel (eque-cel), ib qho kev kho mob T-cell B-cell maturation antigen-targeting chimeric antigen receptor (CAR) uas tau los ntawm tib neeg, tau pom tias muaj peev xwm kho tau ntau yam mob myeloma (R/RMM) uas rov qab mob dua lossis tsis kho tau.

Thaum Lub Rau Hli 30, 2023, Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo Daim Ntawv Thov Tshuaj Tshiab (NDA) rau FUCASO (Equecabtagene Autoleucel), lub ntiaj teb thawj zaug kho mob anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell rau kev kho mob R / RMM uas tau txais ≥3 kab ntawm cov kev kho mob yav dhau los uas muaj tsawg kawg ib qho proteasome inhibitor thiab tus neeg sawv cev immunomodulatory.

Thaum Lub Kaum Ib Hlis 07, 2024, IASO Biotherapeutics tshaj tawm tias cov txiaj ntsig ntawm theem 1b/2 kev tshawb fawb soj ntsuam FUMANBA-1 ntawm nws txoj kev kho mob tiv thaiv BCMA CAR-T tag nrho rau tib neeg, Equecabtagene Autoleucel (lub npe lag luam: Fucaso™), rau kev kho mob R/RMM, tau luam tawm hauv phau ntawv xov xwm kho mob JAMA Oncology. Kev tshawb fawb tau soj ntsuam qhov ua tau zoo thiab kev nyab xeeb ntawm Equecabtagene Autoleucel rau cov neeg mob uas muaj R/RMM uas tau txais ≥3 kab ntawm kev kho mob yav dhau los. Cov txiaj ntsig tau qhia tias Equecabtagene Autoleucel tau txais kev teb sai thiab kev zam txim rau cov neeg mob, nrog rau qhov kev nyab xeeb zoo.

FUMANBA-1 yog ib txoj kev tshawb fawb txog kev kho mob theem 1b/2 uas tau ua nyob rau hauv 14 lub chaw kho mob hauv Suav teb los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm Equecabtagene Autoleucel rau cov neeg mob uas muaj R/RMM uas tau txais ≥3 kab ntawm kev kho mob yav dhau los. Kev sim tshuaj tau sau npe rau cov neeg mob uas muaj R/RMM uas tau txais tsawg kawg peb kab ntawm kev kho mob, suav nrog proteasome inhibitors thiab immunomodulatory agents-based chemotherapy regimens, thiab muaj kev nce qib ntawm kab mob ntawm lawv txoj kev kho mob kawg. Cov neeg mob uas tau txais BCMA CAR-T kev kho mob yav dhau los kuj tsim nyog rau kev sau npe.

Cov txiaj ntsigNtawm 103 tus neeg mob uas tau txais eque-cel infusion, 55 (53.4%) yog txiv neej, thiab lub hnub nyoog nruab nrab (ntau yam) yog 58 (39-70) xyoo. Ntawm qhov nruab nrab (ntau yam) kev saib xyuas ntawm 13.8 (0.4-27.2) lub hlis, Hais txog kev ua tau zoo, ntawm 101 tus neeg mob uas tau soj ntsuam, qhov feem pua ​​​​​​ntawm kev teb tag nrho (ORR) yog 96.0% (97/101), thiab qhov kev teb tiav / qhov kev teb tiav (sCR / CR) yog 74.3% (75/101). Ntawm 89 tus neeg mob uas tsis tau kho CAR-T ua ntej, ORR yog 98.9% (88/89), thiab qhov feem pua ​​​​​​sCR / CR yog 78.7% (70/89). Hauv 101 tus neeg mob no, lub sijhawm nruab nrab los teb yog 16 hnub (ntau yam: 11-179), thaum lub sijhawm nruab nrab ntawm kev teb (DOR) thiab kev ciaj sia tsis muaj kev nce qib nruab nrab (PFS) tseem tsis tau txog. Tus nqi 12-hli PFS yog 78.8% (95% CI: 68.6-86.0). Tsis tas li ntawd, 95% (96/101) ntawm cov neeg mob tau txais qhov tsis zoo ntawm tus kab mob seem (MRD), nrog rau lub sijhawm nruab nrab mus rau MRD tsis zoo ntawm 15 hnub (ntau yam: 14-186). Txhua tus neeg mob uas muaj sCR/CR tau txais MRD tsis zoo, thiab lub sijhawm nruab nrab ntawm MRD tsis zoo tseem tsis tau txog.

Cov Lus Xaus thiab Qhov Tseem CeebHauv qhov kev sim no, eque-cel ua rau cov neeg mob uas tau kho R/RMM ntau zaus thiab muaj kev nyab xeeb thiab tswj tau zoo tau txais txiaj ntsig los ntawm eque-cel.

Tam sim no, muaj ntau lwm yam kev sim tshuaj CAR-T hauv Suav teb, thiab lawv tab tom nrhiav cov neeg mob. Yog xav tau kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.

Xov Tooj: 4008803716

Email：myimmnet@163.com

Cov ntaub ntawv siv los ua piv txwv

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