Ua ʻāpono ʻia ʻo Zevor-cel no ka papa inoa ʻana

Ma Malaki 1, 2024, ua ʻāpono ka ʻĀina Hoʻokele Huahana Lapaʻau Lahui Kina (NMPA) i ka hoʻokuʻu ʻia ʻana o ka huahana kelepona CAR-T ʻo Zevorcabtagene AutoLeucel (Zevor-cel, CT053) no ka mālama ʻana i nā poʻe maʻi makua me ka myeloma multiple relapsed a refractory paha i holomua ma hope o 3 mau laina o ka mālama ʻana (me ka hoʻohana ʻana i hoʻokahi mea hoʻopaʻa proteasome a me ka modulator immune).

Hoʻokumu nui ʻia kēia papa inoa ma kahi hoʻokolohua lapaʻau open-label, single-arm, multi-center phase II (LUMMICAR STUDY 1,NCT03975907) ma Kina, kahi i hoʻokō ai i kahi helu kala 100%.

He 14 mau maʻi me ka makahiki waena o 54 mau makahiki (pae: 34-62), i loaʻa i hoʻokahi infusion o zevor-cel. Ma Iulai 17, 2023, ʻo ka lōʻihi o ka hahai ʻana he 37.7 mau mahina (pae: 14.8-44.2 mau mahina). ʻO ka helu pane holoʻokoʻa (ORR) he 100% (14/14) me 78.6% (11/14) mau maʻi i loaʻa i kahi pane piha (CR) a i ʻole kahi pane piha koʻikoʻi (sCR); ua loaʻa ka liʻiliʻi o ka maʻi koena (MRD) maikaʻi ʻole i nā maʻi āpau i loaʻa i kahi CR a i ʻole sCR. ʻO ka lōʻihi waena o ka pane (mDOR) he 24.1 mau mahina i nā maʻi āpau a me 26.0 mau mahina i ka poʻe i loaʻa iā CR a i ʻole sCR. ʻO ka awelika o ke ola ʻole o ka holomua (mPFS) he 25.0 mau mahina. He 7 (50%) mau maʻi i loko o ka hoʻomaha ʻana i ʻoi aku ma mua o 24 mau mahina. ʻAʻole i hiki i ka awelika o ke ola holoʻokoʻa (OS), a ua ola mau ka 92.9% (13/14) o nā maʻi i ka mahina 36.

Palekana
Ma keʻano holoʻokoʻa, ua hiki ke hoʻokele ʻia ke ʻano palekana o zevor-cel. ʻAʻohe hanana ≥ Grade 3 cytokine release syndrome (CRS). ʻAʻohe hanana immune effector cell-associated neurotoxicity syndrome (ICANS) o kekahi papa. Ua ʻike ʻia ʻekolu mau maʻi Grade 3 e pili ana i ka lāʻau. ʻEkolu mau maʻi i loaʻa nā hanana ʻino koʻikoʻi (SAE) me 2 mau maʻi i loaʻa nā SAE e pili ana i ka lāʻau ʻo ia hoʻi ka maʻi pulmonary a me ka tumor lysis syndrome. He 2 mau make ma ka noiʻi; ʻaʻole pili kekahi i ka zevor-cel.

Hopena
Ua hōʻike ʻo zevor-cel i kahi ʻano palekana hoʻoikaika me nā pane hohonu a paʻa e kūlike ana me nā hopena mua.

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: 4008803716.

Nā Kuhikuhi

1.https://www.carsgen.com/cn/

2.http://sh.news.cn/20240314/2913c85a84be4fbf9345efbd48006971/c.html

3.http://myimm.net/mianyizhiliao/1413.html

4.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240301143753188.html