Equecabtagene autoleucel (eque-cel)

Equecabtagene autoleucel (eque-cel), ọgwụgwọ T-cell nke mkpụrụ ndụ B-cell maturation antigen-targeting chimeric antigen receptor (CAR) sitere na mmadụ, egosila na ọ nwere ike ịgwọ ọrịa myeloma multiple myeloma (R/RMM) nke na-alaghachi azụ ma ọ bụ nke na-adịghị ike.

Na June 30, 2023, National Medical Products Administration nke China (NMPA) akwadola Ngwa Ọgwụ Ọhụrụ (NDA) maka FUCASO (Equecabtagene Autoleucel), ọgwụgwọ T-cell mbụ zuru oke nke antigen-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) maka ọgwụgwọ nke R/RMM onye natara ≥3 nke ọgwụgwọ gara aga nwere opekata mpe otu proteasome inhibitor na ihe na-egbochi immunomodulatory.

Na Nọvemba 07, 2024, IASO Biotherapeutics kwupụtara na nsonaazụ nke ọmụmụ ihe ahụike nke usoro 1b/2 nke FUMANBA-1 nke ọgwụgwọ anti-BCMA CAR-T ya zuru oke, Equecabtagene Autoleucel (aha azụmaahịa: Fucaso™), maka ọgwụgwọ R/RMM, ka ebipụtala na akwụkwọ akụkọ ahụike bụ isi JAMA Oncology. Ọmụmụ ihe ahụ tụlere irè na nchekwa nke Equecabtagene Autoleucel na ndị ọrịa nwere R/RMM bụ ndị natarala usoro ọgwụgwọ mbụ ≥3. Nsonaazụ gosiri na Equecabtagene Autoleucel nwetara ọnụego nzaghachi dị elu na mgbaghara na-adịgide adịgide na ndị ọrịa, yana profaịlụ nchekwa dị mma.

FUMANBA-1 bụ ọmụmụ ihe nyocha nke otu aka, nke e mere na ebe iri na anọ nke ndị China iji chọpụta irè na nchekwa nke Equecabtagene Autoleucel n'ime ndị ọrịa nwere R/RMM bụ ndị natara ≥3 nke ọgwụgwọ gara aga. Nnwale ahụ debara aha ndị ọrịa nwere R/RMM bụ ndị natara ma ọ dịkarịa ala usoro ọgwụgwọ atọ, gụnyere ndị na-egbochi proteasome na usoro chemotherapy dabere na immunomodulatory agents, ma nwee ọganihu ọrịa na usoro ọgwụgwọ ikpeazụ ha. Ndị ọrịa natara ọgwụgwọ BCMA CAR-T mbụ ruru eru maka ndebanye aha.

NsonaazụN'ime ndị ọrịa 103 e tinyere ọgwụ eque-cel, mmadụ 55 (53.4%) bụ ụmụ nwoke, afọ etiti (oke) ahụ bụkwa afọ 58 (39-70). N'oge nyocha nke etiti (oke) nke ọnwa 13.8 (0.4-27.2), N'ihe gbasara irè, n'ime ndị ọrịa 101 a na-enyocha, ọnụego nzaghachi zuru oke (ORR) bụ 96.0% (97/101), na oke nzaghachi zuru oke/oke nzaghachi zuru oke (sCR/CR) bụ 74.3% (75/101). N'ime ndị ọrịa 89 na-enweghị ọgwụgwọ CAR-T mbụ, ORR bụ 98.9% (88/89), ọnụego sCR/CR bụkwa 78.7% (70/89). N'ime ndị ọrịa 101 a, oge etiti iji zaghachi bụ ụbọchị 16 (oke: 11-179), ebe erubeghị oge etiti nke nzaghachi (DOR) na ndụ etiti nke enweghị ọganihu (PFS). Ọnụego PFS nke ọnwa 12 bụ 78.8% (95% CI: 68.6-86.0). Na mgbakwunye, 95% (96/101) nke ndị ọrịa nwetara obere ihe na-adịghị mma nke ọrịa fọdụrụ (MRD), yana oge etiti ruo na MRD negativity nke ụbọchị 15 (oke: 14-186). Ndị ọrịa niile nwere sCR/CR nwetara MRD negativity, a rubeghịkwa oge etiti nke MRD negativity.

Mmechi na MkpaN'ime nnwale a, eque-cel dugara n'inweta nzaghachi mbụ, miri emi, na nke siri ike n'ime ndị ọrịa nwere nnukwu ọgwụgwọ R/RMM nke nwere profaịlụ nchekwa a na-achịkwa. Ndị ọrịa nwere ọgwụgwọ CAR T-cell gara aga ritekwara uru site na eque-cel.

Ugbu a, enwere ọtụtụ nnwale ụlọ ọgwụ CAR-T ndị ọzọ na China, ha na-achọkwa ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ ọhụrụ na teknụzụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

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Ntụaka

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