I-Equecabtagene autoleucel (eque-cel)

I-Equecabtagene autoleucel (eque-cel), ukwelashwa kwe-T-cell okuqondiswe ku-B-cell maturation-targeting chimeric antigen receptor (CAR) okususelwa kumuntu ngokugcwele, kubonise amandla okwelapha i-repeatable noma i-refractory multiple myeloma (R/RMM).

Ngomhlaka-30 Juni 2023, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-New Drug Application (NDA) ye-FUCASO (Equecabtagene Autoleucel), ukwelashwa kokuqala kwe-T-cell anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) emhlabeni kokwelashwa kwe-R/RMM eyathola imigqa engu-≥3 yezindlela zokwelapha zangaphambilini eziqukethe okungenani i-proteasome inhibitor eyodwa kanye ne-immunomodulatory agent.

Ngomhlaka-07 Novemba 2024, i-IASO Biotherapeutics yamemezela ukuthi imiphumela yocwaningo lwezokwelapha lwesigaba 1b/2 i-FUMANBA-1 yokwelashwa kwayo okulwa ne-BCMA CAR-T ngabantu ngokuphelele, i-Equecabtagene Autoleucel (igama lokuhweba: i-Fucaso™), yokwelapha i-R/RMM, ishicilelwe ephephabhukwini lezokwelapha elihamba phambili i-JAMA Oncology. Ucwaningo luhlole ukusebenza kahle nokuphepha kwe-Equecabtagene Autoleucel ezigulini ezine-R/RMM ezazithole imigqa engu-≥3 yokwelashwa kwangaphambilini. Imiphumela ibonise ukuthi i-Equecabtagene Autoleucel ithole izinga eliphezulu lokuphendula kanye nokuxolelwa okuhlala isikhathi eside ezigulini, ngephrofayili yokuphepha enhle.

I-FUMANBA-1 iyisifundo somtholampilo sokubhalisa sesigaba 1b/2 esinengalo eyodwa, esivulekile esenziwe ezikhungweni eziyi-14 zaseShayina ukuhlola ukusebenza kahle nokuphepha kwe-Equecabtagene Autoleucel ezigulini ezine-R/RMM ezithole imigqa engu-≥3 yokwelashwa kwangaphambilini. Ukuhlolwa kwabhalisa iziguli ezine-R/RMM ezazithole okungenani imigqa emithathu yokwelashwa ngaphambilini, okuhlanganisa ama-proteasome inhibitors kanye nemithi yokwelapha esekwe kuma-immunomodulatory agents, futhi zaqhubeka nesifo emgqeni wazo wokugcina wokwelashwa. Iziguli ezazithole ukwelashwa kwe-BCMA CAR-T ngaphambilini nazo zazifanelekela ukubhaliswa.

ImiphumelaEzigulini eziyi-103 ezathola ukumnika i-eque-cel, ezingama-55 (53.4%) kwakungabesilisa, kanti ubudala obuphakathi (bebanga) babuyiminyaka engama-58 (39-70). Ekulandeleni okuphakathi (bebanga) kwezinyanga eziyi-13.8 (0.4-27.2), Ngokuphathelene nokusebenza kahle, phakathi kweziguli eziyi-101 ezihlolwayo, izinga lokuphendula lilonke (ORR) lalingu-96.0% (97/101), kanti izinga lokuphendula eliphelele eliqinile/eliphelele (sCR/CR) lalingu-74.3% (75/101). Phakathi kweziguli ezingama-89 ezazingenalo ukwelashwa kwe-CAR-T ngaphambilini, i-ORR yayingu-98.9% (88/89), kanti izinga le-sCR/CR lalingu-78.7% (70/89). Kulezi ziguli eziyi-101, isikhathi esimaphakathi sokuphendula kwakuyizinsuku eziyi-16 (ububanzi: 11-179), kuyilapho isikhathi esimaphakathi sokuphendula (i-DOR) kanye nokusinda okumaphakathi okungenalo inqubekela phambili (i-PFS) kwakungakafinyelelwa. Izinga le-PFS lezinyanga eziyi-12 lalingu-78.8% (95% CI: 68.6-86.0). Ngaphezu kwalokho, ama-95% (96/101) eziguli athole ukungabi nalutho okuncane kwesifo esisele (i-MRD), kanye nesikhathi esimaphakathi sokungalungi kwe-MRD sezinsuku eziyi-15 (ububanzi: 14-186). Zonke iziguli ezine-sCR/CR zithole ukungabi nalutho kwe-MRD, kanti isikhathi esimaphakathi sokungalungi kwe-MRD sasingakafinyelelwa.

Iziphetho NokufanelekaKulolu cwaningo, i-eque-cell yaholela ezimpendulweni zakuqala, ezijulile, nezihlala isikhathi eside ezigulini ezine-R/RMM elashwe kakhulu ngaphambilini enephrofayili yokuphepha elawulekayo. Iziguli ezake zathola ukwelashwa kwe-CAR T-cell ngaphambilini nazo zazuza ku-eque-cel.

Njengamanje, kunezinye izivivinyo eziningi ze-CAR-T eShayina, futhi zifuna iziguli. Ukuze uthole ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

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