Equecabtagene autoleucel (eque-cel)

Equecabtagene autoleucel (eque-cel), kalafo ea lisele tsa T tse entsoeng ke motho ka botlalo e hlahisang antigen-targeting chimeric antigen receptor (CAR), e bontšitse bokhoni ba ho phekola myeloma e mengata e kgutlelang morao kapa e sa laoleheng (R/RMM).

Ka la 30 Phuptjane, 2023, Tsamaiso ea Naha ea Lihlahisoa tsa Bongaka ea Chaena (NMPA) e amohetse Kopo e Ncha ea Meriana (NDA) bakeng sa FUCASO (Equecabtagene Autoleucel), kalafo ea pele lefatšeng ea li-antigen tsa maturation tsa lisele tsa B (BCMA) chimeric antigen receptor (CAR) bakeng sa kalafo ea R/RMM e fumaneng mela e ≥3 ea mekhoa ea phekolo ea pele e nang le bonyane proteasome inhibitor e le 'ngoe le moemeli oa immunomodulatory.

Ka la 7 Pulungoana, 2024, IASO Biotherapeutics e phatlalalitse hore liphetho tsa thuto ea kliniki ea mohato oa 1b/2 FUMANBA-1 ea phekolo ea eona ea anti-BCMA CAR-T e felletseng ho batho, Equecabtagene Autoleucel (lebitso la khoebo: Fucaso™), bakeng sa kalafo ea R/RMM, li phatlalalitsoe koranteng e ka sehloohong ea bongaka ea JAMA Oncology. Phuputso e hlahlobile katleho le polokeho ea Equecabtagene Autoleucel ho bakuli ba nang le R/RMM ba neng ba kile ba fumana mela e ≥3 ea mekhoa ea phekolo ea pele. Liphetho li bontšitse hore Equecabtagene Autoleucel e fihletse sekhahla se phahameng sa karabelo le pholiso e tšoarellang ho bakuli, ka boemo bo botle ba polokeho.

FUMANBA-1 ke phuputso ea bongaka ea letsoho le le leng, e bulehileng ea mohato oa 1b/2 e entsoeng litsing tse 14 tsa Chaena ho lekola katleho le polokeho ea Equecabtagene Autoleucel ho bakuli ba nang le R/RMM ba fumaneng mela e ≥3 ea mekhoa ea phekolo ea pele. Teko e ngolisitse bakuli ba nang le R/RMM ba kileng ba fumana bonyane mela e meraro ea phekolo, ho kenyeletsoa le li-inhibitor tsa proteasome le mekhoa ea chemotherapy e thehiloeng ho li-immunomodulatory agents, 'me ba bile le tsoelo-pele ea lefu moleng oa bona oa ho qetela oa phekolo. Bakuli ba kileng ba fumana phekolo ea BCMA CAR-T le bona ba ne ba tšoaneleha ho ngolisoa.

LiphethoHo bakuli ba 103 ba ileng ba fumana ente ea eque-cel, ba 55 (53.4%) e ne e le banna, 'me lilemo tse mahareng (tsa mefuta e fapaneng) e ne e le lilemo tse 58 (39-70). Tekolong e mahareng (tsa mefuta e fapaneng) ea likhoeli tse 13.8 (0.4-27.2), Mabapi le katleho, har'a bakuli ba 101 ba hlahlojoang, sekhahla sa karabelo (ORR) ka kakaretso e ne e le 96.0% (97/101), 'me sekhahla se tiileng sa karabelo/karabelo e felletseng (sCR/CR) e ne e le 74.3% (75/101). Har'a bakuli ba 89 ba neng ba se na kalafo ea CAR-T pele, ORR e ne e le 98.9% (88/89), 'me sekhahla sa sCR/CR e ne e le 78.7% (70/89). Ho bakuli bana ba 101, nako e mahareng ea karabelo e ne e le matsatsi a 16 (sebaka: 11-179), ha nako e mahareng ea karabelo (DOR) le nako e mahareng ea ho phela ntle le tsoelo-pele (PFS) li ne li e-so fihlelloe. Sekhahla sa PFS sa likhoeli tse 12 e ne e le 78.8% (95% CI: 68.6-86.0). Ho phaella moo, 95% (96/101) ea bakuli e fihletse negativity e fokolang ea lefu le setseng (MRD), ka nako e mahareng ea negativity ea MRD ea matsatsi a 15 (sebaka: 14-186). Bakuli bohle ba nang le sCR/CR ba fihletse negativity ea MRD, 'me nako e mahareng ea negativity ea MRD e ne e e-so fihlelloe.

Liqeto le BohlokoaTekong ena, eque-cel e lebisitse likarabelong tsa pele, tse tebileng le tse tšoarellang ho bakuli ba nang le R/RMM e neng e phekoloa esale pele haholo ba nang le boemo ba polokeho bo laolehang. Bakuli ba neng ba e-na le phekolo ea pele ea lisele tsa CAR T le bona ba ruile molemo ho eque-cel.

Hona jwale, ho na le diteko tse ding tse ngata tsa bongaka tsa CAR-T Chaena, mme di batla bakudi. Bakeng sa ditherisano mabapi le meriana le mahlale a matjha, o ka ikopanya le Lefapha la Matjhaba la Sepetlele sa Oncology sa Beijing Region South.

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Email：myimmnet@163.com

Litšupiso

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