Equecabtagene autoleucel (eque-cel)

Ko te Equecabtagene autoloucel (eque-cel), he rongoā pūtau-T e aro ana ki te whakatipu antigen chimeric antigen receptor (CAR) i ahu mai i te tangata, kua whakaatuhia te kaha mō te rongoā i te myeloma maha kua hoki mai, kua uaua rānei te whakatika (R/RMM).

I te 30 o Hune, 2023, kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te Tono Rongoā Hou (NDA) mō te FUCASO (Equecabtagene Autoleucel), te rongoā pūtau-T tuatahi o te ao e whakamahi ana i te antigen maturation cell-B antigen (BCMA) chimeric antigen receptor (CAR) mō te rongoā i te R/RMM i whiwhi i te ≥3 rārangi o ngā rongoā o mua kei roto i te iti rawa kotahi te aukati proteasome me te kaihoko immunomodulatory.

I te 7 o Noema, 2024, i panuitia e te IASO Biotherapeutics kua whakaputaina ngā hua o te rangahau haumanu wāhanga 1b/2 FUMANBA-1 o tana rongoā tangata-ā-tangata anti-BCMA CAR-T, Equecabtagene Autoleucel (ingoa hokohoko: Fucaso™), mō te maimoatanga o te R/RMM, i roto i te puka hauora matua JAMA Oncology. I arotakehia e te rangahau te whai huatanga me te haumaru o Equecabtagene Autoleucel i roto i ngā tūroro me te R/RMM i whiwhi i mua i te ≥3 raina o ngā maimoatanga o mua. I whakaatuhia e ngā hua i eke a Equecabtagene Autoleucel ki te reiti urupare whānui me te murunga roa i roto i ngā tūroro, me te kōtaha haumaru pai.

He rangahau haumanu rēhitatanga wāhanga 1b/2 tuwhera-wāhanga kotahi-ringa, i whakahaerehia i roto i ngā pokapū Hainamana 14 hei aromatawai i te whai huatanga me te haumaru o te Equecabtagene Autoleucel i roto i ngā tūroro he R/RMM kua whiwhi i te ≥3 raina o ngā maimoatanga o mua. I whakaurua e te whakamātautau ngā tūroro he R/RMM kua whiwhi i te iti rawa e toru raina o te maimoatanga, tae atu ki ngā aukati proteasome me ngā tikanga chemotherapy e hangai ana ki ngā kaihoko ārai mate, ā, kua piki haere te mate i tā rātou raina maimoatanga whakamutunga. I āhei hoki ngā tūroro kua whiwhi i te maimoatanga BCMA CAR-T i mua ki te whakauru.

Ngā HuaI roto i ngā tūroro 103 i whiwhi i te werohanga eque-cel, 55 (53.4%) he tāne, ā, ko te tau waenga (awhe) he 58 (39-70) tau. I te aroturukitanga waenga (awhe) o te 13.8 (0.4-27.2) marama, Mō te whai huatanga, i roto i ngā tūroro 101 i taea te arotake, ko te reiti urupare whānui (ORR) he 96.0% (97/101), ā, ko te reiti urupare katoa/whakautu katoa (sCR/CR) he 74.3% (75/101). I roto i ngā tūroro 89 kāore i mua i te rongoā CAR-T, ko te ORR he 98.9% (88/89), ā, ko te reiti sCR/CR he 78.7% (70/89). I roto i ēnei tūroro 101, ko te wā toharite ki te urupare he 16 ngā rā (awhe: 11-179), engari kāore anō kia tutuki te roanga toharite o te urupare (DOR) me te oranga kore-haere-ake (PFS). Ko te reiti PFS 12-marama he 78.8% (95% CI: 68.6-86.0). Hei tāpiri, 95% (96/101) o ngā tūroro i tutuki te iti rawa o te mate toenga (MRD) kino, me te wā toharite ki te kore MRD he 15 ngā rā (awhe: 14-186). Ko ngā tūroro katoa me te sCR/CR i tutuki te kore MRD, ā, kāore anō kia tutuki te roanga toharite o te kore MRD kino.

Ngā Whakatau me te HirangaI roto i tēnei whakamātautau, i hua ake i a eque-cel ngā urupare wawe, hohonu, me te roa i roto i ngā tūroro i whiwhi i te R/RMM i mua i te maimoatanga nui me te kōtaha haumaru ka taea te whakahaere. I whai hua anō hoki ngā tūroro i whiwhi i te rongoā pūtau-T CAR o mua i a eque-cel.

I tēnei wā, he maha atu ngā whakamātautau haumanu CAR-T i Haina, ā, kei te rapu tūroro rātou. Mō te kōrerorero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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Ngā Tohutoro

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