Equecabtagene autoleucel (eque-cel)

ʻO Equecabtagene autoleucel (eque-cel), kahi lāʻau lapaʻau T-cell chimeric antigen receptor (CAR) maturation B-cell maturation i loaʻa piha i ke kanaka, ua hōʻike i ka hiki ke mālama i ka myeloma multiple relapsed a refractory paha (R/RMM).

Ma Iune 30, 2023, ua ʻāpono ka National Medical Products Administration (NMPA) o Kina i ka New Drug Application (NDA) no FUCASO (Equecabtagene Autoleucel), ʻo ia ka lāʻau lapaʻau T-cell chimeric antigen receptor (CAR) mua loa o ka honua no ka mālama ʻana i ka R/RMM i loaʻa i ≥3 mau laina o nā lāʻau lapaʻau mua e loaʻa ana ma ka liʻiliʻi hoʻokahi proteasome inhibitor a me kahi mea immunomodulatory.

Ma Nowemapa 07, 2024, ua hoʻolaha ʻo IASO Biotherapeutics ua paʻi ʻia nā hopena o ka haʻawina lapaʻau pae 1b/2 FUMANBA-1 o kāna lāʻau lapaʻau anti-BCMA CAR-T kanaka piha, ʻo Equecabtagene Autoleucel (inoa kālepa: Fucaso™), no ka mālama ʻana iā R/RMM, ma ka puke pai lapaʻau koʻikoʻi ʻo JAMA Oncology. Ua loiloi ke aʻo ʻana i ka pono a me ka palekana o Equecabtagene Autoleucel i nā maʻi me R/RMM i loaʻa mua i ≥3 mau laina o nā lāʻau lapaʻau mua. Ua hōʻike nā hopena ua loaʻa iā Equecabtagene Autoleucel kahi pane kiʻekiʻe a me ke kala mau loa i nā maʻi, me kahi ʻano palekana maikaʻi.

He haʻawina lapaʻau hoʻopaʻa inoa lima hoʻokahi ʻo FUMANBA-1, open-label phase 1b/2 i mālama ʻia ma 14 mau kikowaena Kina e loiloi i ka pono a me ka palekana o ka Equecabtagene Autoleucel i nā poʻe maʻi me R/RMM i loaʻa i ≥3 mau laina o nā lāʻau lapaʻau ma mua. Ua hoʻopaʻa inoa ka hoʻokolohua i nā poʻe maʻi me R/RMM i loaʻa mua ma ka liʻiliʻi he ʻekolu mau laina o ka lāʻau lapaʻau, me nā mea hoʻopaʻa proteasome a me nā regimen chemotherapy e pili ana i nā mea immunomodulatory, a ua loaʻa ka holomua o ka maʻi ma kā lākou laina hope loa o ka lāʻau lapaʻau. Ua kūpono hoʻi nā poʻe maʻi i loaʻa mua i ka lāʻau lapaʻau BCMA CAR-T no ke kākau inoa ʻana.

Nā HualoaʻaMa waena o nā maʻi 103 i loaʻa i ka hoʻokomo ʻana o ka eque-cel, he kāne he 55 (53.4%), a ʻo ka makahiki waena (range) he 58 (39-70) mau makahiki. Ma kahi hahai waena (range) o 13.8 (0.4-27.2) mau mahina, Ma ke ʻano o ka pono, ma waena o nā maʻi 101 i hiki ke loiloi ʻia, ʻo ka helu pane holoʻokoʻa (ORR) he 96.0% (97/101), a ʻo ka helu pane piha/pane piha koʻikoʻi (sCR/CR) he 74.3% (75/101). Ma waena o nā maʻi 89 me ka ʻole o ka lāʻau lapaʻau CAR-T ma mua, ʻo ka ORR he 98.9% (88/89), a ʻo ka helu sCR/CR he 78.7% (70/89). I loko o kēia mau maʻi 101, ʻo ka manawa waena e pane ai he 16 mau lā (pae: 11-179), ʻoiai ʻaʻole i hiki i ka manawa waena o ka pane (DOR) a me ka manawa waena o ke ola ʻole o ka holomua (PFS). ʻO ka helu PFS 12 mahina he 78.8% (95% CI: 68.6-86.0). Eia kekahi, 95% (96/101) o nā maʻi i loaʻa ka liʻiliʻi o ka maʻi koena (MRD) negativity, me ka manawa waena i ka manawa MRD negativity o 15 mau lā (pae: 14-186). Ua loaʻa i nā maʻi āpau me sCR/CR ka manawa MRD negativity, a ʻaʻole i hiki i ka manawa waena o ka manawa MRD negativity.

Nā Hopena a me ke PiliMa kēia hoʻokolohua, ua alakaʻi ʻo eque-cel i nā pane mua, hohonu, a paʻa hoʻi i nā poʻe maʻi me ka R/RMM i mālama mua ʻia me kahi ʻano palekana e hiki ke hoʻokele ʻia. Ua pōmaikaʻi pū nā poʻe maʻi me ka lāʻau lapaʻau CAR T-cell ma mua mai ka eque-cel.

I kēia manawa, nui nā hoʻokolohua lapaʻau CAR-T ʻē aʻe ma Kina, a ke ʻimi nei lākou i nā maʻi. No ke kūkākūkā ʻana i nā lāʻau lapaʻau hou a me nā ʻenehana, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.

Helu Kelepona：4008803716

Email：myimmnet@163.com

Nā Kuhikuhi

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