I-Relmacabtagene Autoleucel Injection

Ngomhla wesi-6 kweyoMsintsi, ngo-2021, i-JW Therapeutics ibhengeze ukuba i-National Medical Products Administration (NMPA) yaseTshayina ivumile i-New Drug Application (NDA) ye-anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (relma-cel) yokunyanga izigulane zabantu abadala abane-relapse okanye refractory large B-cell lymphoma (r/r LBCL) emva kwemigca emibini nangaphezulu yonyango lwe-systemic, kwaye ikhuphe isatifiketi sokubhaliswa kwamayeza. I-Relma-cel yimveliso yokuqala ye-CAR-T evunyiweyo njengemveliso yebhayoloji yodidi 1 eTshayina, kwaye yimveliso yesithandathu ye-CAR-T evunyiweyo kwihlabathi liphela.

Malunga neRelmacabtagene Autoleucel Injection (igama lorhwebo: Carteyva®)

I-Relmacabtagene autoleucel injection (efinyeziweyo njenge-relma-cel, igama lorhwebo: Carteyva) yimveliso ye-autologous anti-CD19 CAR-T cell immunotherapy eyenziwe ngokuzimeleyo yi-JW Therapeutics esekelwe kwiqonga lenkqubo yeseli ye-CAR-T yeJuno Therapeutics (inkampani yaseBristol Myers Squibb).

Olu vunyiweyo lusekelwe kwiziphumo zophando olujolise kwi-single-arm, multi-center, pical study (i-RELIANCE study) ukuvavanya ukusebenza kakuhle kunye nokhuseleko lwe-relma-cel kwizigulane ezine-r/r LBCL eTshayina. Iziphumo zophando lwe-RELIANCE zibonisa ukuba i-relma-cel ibonise amazinga aphezulu okuphendula kwesifo esihlala ixesha elide kunye namazinga aphantsi etyhefu enxulumene ne-CAR-T, kwaye inokubonelela ngeprofayili yonyango lwe-CAR-T engcono kakhulu.

KwiNtlanganiso yoNyaka yama-24 ye-Chinese Society of Clinical Oncology (CSCO), i-JW Therapeutics ibhengeze iziphumo zokulandelela ezihlaziyiweyo zonyaka omnye ze-relmacabtagene autoleucel injection (relma-cel) kunyango lwe-r/r LBCL. Iziphumo ziquka:

I-Relma-cel ibonise iimpendulo ezihlala ixesha elide kunye nenzuzo yokusinda ixesha elide; i-Best Overall Response Rate (ORR) yayiyi-77.6%, i-Best Complete Response Rate (CRR) yayiyi-51.7% kwaye i-Overall Survival (OS) yonyaka omnye yayiyi-76.8% kunye nokulandelelana okuphakathi kweenyanga ezili-17.9;

I-Relma-cel yayiqheleke kakuhle ngeprofayili yokhuseleko equka i-Cytokine Release Syndrome ephantsi kakhulu (≥ibanga lesi-3) ye-5.1% kunye nezinga eliphantsi le-neurotoxicity (≥ibanga lesi-3) ye-3.4%, kwaye akukho zimpawu zintsha zokhuseleko ezinomlinganiselo weenyanga ezili-17.9 zokulandelelana;

Ukulandelelana kwexesha elide kophando lwe-RELIANCE kuqinisekisile ukuqina kwempendulo kunye ne-OS yexesha elide ngonyango lwe-relma-cel, olukwanxulunyaniswa namazinga aphantsi etyhefu enxulumene ne-CAR-T.

I-LBCL lolona hlobo luqhelekileyo nolunobundlongondlongo lwe-non-Hodgkin lymphoma kwaye uninzi lwezigulane lubuyela umva emva konyango lokuqala oluneendlela ezimbalwa zonyango ezinonyango oluqhelekileyo kunye nokusinda okuphakathi kweenyanga ezi-6. Olu lwazi lokulandelelana oluxelwe kwisifundo se-RELIANCE luqinisekisile ukuqina kweempendulo emva konyango lwe-relma-cel, olumele ukhetho lonyango olunokuba lubalulekileyo kwezi zigulane olubonakala lunika ithemba elicacileyo lokuphila ixesha elide.

Okwangoku, kukho ezinye iimvavanyo ezininzi zeklinikhi ze-CAR-T eTshayina, kwaye zikhangela izigulane. Ukuze ufumane iingcebiso ngamayeza amatsha kunye netekhnoloji, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

Inombolo yefowuni: 4008803716

Email：myimmnet@163.com

Iireferensi

1.https://www.jwtherapeutics.com/en/media/press-release/jw-therapeutics-announces-nmpa-approval-of-relmacabtagene-autoleucel-injection-in-china/

2.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20210903084004127.html

3.https://www.sciencedirect.com/science/article/pii/S0006497118704138

4.https://www.jwtherapeutics.com/en/media/press-release/jw-therapeutics-announces-updated-1-year-follow-up-result-of-relmacabtagene-autoleucel-injection-at-the-24th-annual-meeting-of-the-chinese-society-of-clinical-oncology-csco-1/