Equecabtagene autoleucel (eque-cel)

Equecabtagene autoleucel (eque-cel), iyo inotorwa nevanhu zvizere seB-cell maturation antigen-targeting chimeric antigen receptor (CAR) T-cell therapy, yakaratidza mukana wekurapa recurly kana refractory multiple myeloma (R/RMM).

Musi wa30 Chikumi, 2023, National Medical Products Administration (NMPA) yeChina yakabvumidza New Drug Application (NDA) yeFUCASO (Equecabtagene Autoleucel), iyo yekutanga pasi rose inorwisa mabhakitiriya eB cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy yekurapa R/RMM iyo yakagamuchira ≥3 nzira dzekurapa dzakapfuura dzine proteasome inhibitor imwe chete uye immunomodulatory agent.

Musi wa7 Mbudzi, 2024, IASO Biotherapeutics yakazivisa kuti mhedzisiro yechidzidzo chekiriniki chechikamu 1b/2 cheFUMANBA-1 chekurapa kwayo kwekurwisa BCMA CAR-T kwevanhu, Equecabtagene Autoleucel (zita rekutengeserana: Fucaso™), yekurapa R/RMM, yakabudiswa mumagazini yezvekurapa yakakurumbira yeJAMA Oncology. Chidzidzo ichi chakaongorora kushanda uye kuchengetedzeka kweEquecabtagene Autoleucel muvarwere vane R/RMM vakambogamuchira ≥3 yemishonga yapfuura. Mhedzisiro yacho yakaratidza kuti Equecabtagene Autoleucel yakawana mhinduro yepamusoro uye kuregererwa kwenguva refu muvarwere, nekuchengetedzwa kwakanaka.

FUMANBA-1 iongororo yekiriniki yechikamu chimwe chete, chakavhurika chechikamu 1b/2 chakaitwa munzvimbo gumi nemana dzekuChina kuti vaongorore kushanda uye kuchengetedzeka kweEquecabtagene Autoleucel muvarwere vane R/RMM vakamborapwa kare. Kuongororwa kwacho kwakanyoresa varwere vane R/RMM vakamborapwa katatu, kusanganisira proteasome inhibitors uye immunomodulatory agents-based chemotherapy regimens, uye vakaenderera mberi nechirwere pakurapwa kwavo kwekupedzisira. Varwere vakamborapwa BCMA CAR-T vakakodzerawo kunyoreswa.

MhedzisiroPavarwere 103 vakapihwa eque-cel infusion, 55 (53.4%) vaive varume, uye zera repakati (renji) raive makore 58 (39-70). Pakutevera kwepakati (renji) kwemwedzi 13.8 (0.4-27.2), Panyaya yekushanda zvakanaka, pakati pevarwere 101 vakaongororwa, huwandu hwemhinduro (ORR) hwaive 96.0% (97/101), uye huwandu hwemhinduro yakakwana (sCR/CR) hwaive 74.3% (75/101). Pakati pevarwere 89 vasina kurapwa kweCAR-T kare, ORR yaive 98.9% (88/89), uye huwandu hwesCR/CR hwaive 78.7% (70/89). Muvarwere ava 101, nguva yepakati yekupindura yaive mazuva gumi nematanhatu (kubva: 11-179), nepo nguva yepakati yekupindura (DOR) uye nguva yepakati yekupona isina kuenderera mberi (PFS) yakanga isati yasvika. Chiyero chePFS chemwedzi gumi nemiviri chaive 78.8% (95% CI: 68.6-86.0). Pamusoro pezvo, 95% (96/101) yevarwere vakawana kusawirirana kushoma kwechirwere (MRD), nenguva yepakati kusvika kukusawirirana kweMRD yemazuva gumi nemashanu (kubva: 14-186). Varwere vese vane sCR/CR vakawana kusawirirana kweMRD, uye nguva yepakati yekusawirirana kweMRD yakanga isati yasvika.

Mhedziso uye KukoshaMukuedzwa uku, eque-cell yakatungamira kumhinduro dzekutanga, dzakadzika, uye dzinogara kwenguva refu muvarwere vaive neR/RMM yakamborapwa kare uye vaive neruzivo rwekuchengetedza runogoneka. Varwere vaive neCAR T-cell therapy kare vakabatsirwawo ne eque-cel.

Parizvino, kune mimwe miedzo yakawanda yeCAR-T muChina, uye vari kutsvaga varwere. Kuti muwane mazano pamusoro pemishonga mitsva netekinoroji, munogona kubata Beijing South Region Oncology Hospital International Department.

Nhamba yefoni: 4008803716

Email：myimmnet@163.com

Mareferensi

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