NDA ya pCAR-19B yo kuvura kanseri y'amaraso mu bana yemejwe na NMPA

Ku itariki ya 20 Nyakanga, hashyizweho uburyo bushya bwo gukoresha imiti(NDA) ya pCAR-19B yakozwe ku giti cyayo na Precision Biology yemewe ku mugaragaro n’Ikigo cy’Igihugu cy’Ubuvuzi cy’Ubushinwa (NMPA). Iki gicuruzwa ni cyo gicuruzwa cya mbere cya CAR-T ku ndwara ya kanseri y’abana mu Bushinwa, gikoreshwa mu kuvura abarwayi bari hagati y’imyaka 3 na 21 bafite kanseri y’amaraso ya CD19 yasubiwemo/yasubiwemo/ifite aho ihurira n’indwara ya kanseri y’amaraso (ALL).

Leukemia y'urumogi itera kanseri (ALL) ni imwe mu ndwara zikunze kugaragara mu bana kandi ikaba ari yo mpamvu ikomeye itera impfu mu bana n'ingimbi. Uburyo bwo kuvura bwa "chimeric antigen receptor" (CAR-T) bwahinduye uburyo bwo kuvura indwara ya "relapse/refractory" (R/R), aho umuti wa mbere wemejwe na FDA, Kymriah (tisagenlecleucel) wakozwe na Novartis, binongera cyane igipimo cyo koroherwa no kubaho.

pCAR-19B ni ikintu cy’uturemangingo twa CAR-T gifite agace ka CD19 gafite ubwoko bwa CD19 (scFv) gakozwe mu buryo bwa muntu, gakozwe mu rwego rwo gukemura ibibazo by’umutekano.

Mu Gushyingo 2023, pCAR-19B yahawe "Icyitegererezo cyo kuvura indwara ziterwa n'impinduka" n'Ikigo cy'Igihugu cy'Ubushinwa gishinzwe imiti y'ubuvuzi kugira ngo ivure B-ALL.

Ingaruka nziza n'umutekano bya pCAR-19B mu igerageza ry'ingenzi ryakorewe ku barwayi b'abana n'urubyiruko bo mu Bushinwa bafite R/R B-cell ALLbyatangajwe kuriInama ngarukamwaka ya 66 y’Umuryango w’Abanyamerika w’Ubuvuzi bw’Amazi (ASH).

Uburyo: Ubu bushakashatsi bwakozwe mu cyiciro cya kabiri (NCT05334823) bwari ubushakashatsi bwakozwe mu buryo bumwe, bukozwe mu buryo bw’icyitegererezo, kandi bukorerwa mu nzego nyinshi. Abarwayi bafite imyaka ≥ 3 na ≤ 21 bari mu isuzuma rya CD19+ R/R B-ALL byemejwe barashyizwemo. Ishingiro ry’ibanze ryari igipimo rusange cyo kuruhuka (ORR), gisobanurwa nk'ihumure ryuzuye (CR) hamwe na CR hamwe n'amaraso adahagije yo gukira (CRi) mu mezi 3 nyuma yo guterwa.

Ibisubizo: Ku ya 18 Mata 2024, abarwayi 89 bari bariyandikishije kandi bakorerwa leukapheresis, aho abarwayi 64 bahawe pCAR-19B infusion. Nta kibazo cy’uko inganda zangiritse cyagaragaye. Mu barwayi batewe, 6.25% (4/64) bari barwaye indwara yo kutagira icyo ikora naho 93.75% (60/64) bongeye gusubira ku miti myinshi yabanje cyangwa guterwa allogeneic stem cell. Impuzandengo y’imyaka yari imyaka 11 (kuva kuri 3 kugeza kuri 21), naho 56.25% (36/64) bari abagabo. Byongeye kandi, 75% (48/64) by’abarwayi bari bafite nibura gene imwe ifite ibyago byinshi. Umutwaro w’impuzandengo y’umusemburo w’amagufwa (BM) ku ikubitiro wari 58.3% (kuva kuri 5% kugeza kuri 98%) hamwe n’umutwaro uremereye w’impuzandengo (≥50%) wagaragaye muri 56.25% by’abarwayi.

Mu ikurikirana ry’iminsi 211 (kuva kuri 35-750), ORR nziza cyane yari 90.63% (58/64), aho 78.13% by’abarwayi (50/64) bagezeho CR na 12.5% ​​by’abarwayi (8/64) bagezeho CRi, birenga ubushobozi bw’imiti igabanya CD19 CAR-T yatanzwe muri R/R B-ALL. 98.27% (57/58) by’abarwayi ba ORR bagezeho kugabanuka kwa negative negative disease (MRD). ORR mu mezi 3 yari 76.56% (49/64). Igihe cyo hagati cyo gusubiza (DOR) cyari amezi 10.61 (95% igihe cyo hagati cyo hagati cyo hagati cyo hagati cyo hagati cyo hagati ya 7.66-20.96). Igihe cyo hagati cyo kubaho (OS) cyari amezi 23.92 (95% igihe cyo hagati cyo hagati cyo hagati cyo hagati ya 9.86-NR).

Indwara ya Cytokine release syndrome (CRS) na immuno effect cell-associated neurotoxicity syndrome (ICANS) byagaragaye ku barwayi 98.44% na 50%, uko bikurikirana. Indwara ya ≥3 CRS na ICANS byagaragaye ku barwayi 29.69% na 39.06%. Igihe cy'impinduka cya CRS na ICANS cyo ku rwego rwa ≥3 cyari iminsi 4 n'iminsi 3, uko bikurikirana. Nta rupfu rwagaragaye kubera CRS cyangwa ICANS.

Umwanzuro: Nubwo hari umutwaro uremereye w’ibisasu bya BM n’ibyago byinshi byo guhinduka kw’uturemangingo, pCAR-19B yagaragaje igipimo cyo kugabanuka cyane, yageze ku gipimo cyo kugabanuka kwa MRD, ibisubizo birambye, n’umutekano wihanganirwa. Ubu bushakashatsi ni bwo bwa mbere bw’ingenzi mu igeragezwa ry’indwara ya B-ALL mu bana mu baturage bo muri Aziya, butanga uburyo bushya bwo kuvura abana n’urubyiruko bo mu Bushinwa bafite R/R B-ALL.

Kuri ubu, hari andi magerageza menshi ya CAR-T mu Bushinwa, kandi barimo gushaka abarwayi. Kugira ngo ubone inama ku miti mishya n'ikoranabuhanga, ushobora kuvugana n'Ishami Mpuzamahanga ry'Ibitaro bya Oncology bya Beijing Region South.

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Amareferensi

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2. http://cq.news.cn/20240728/b0a74788930d4be7a45996be2808dd4f/c.html

3.https://mp.weixin.qq.com/s?__biz=MzAxMzgzOTk1OQ==&mid=2650794360&idx=1&sn=f1628888e194d1c2d0fb05894f92a969&chksm=83973240b4e0bb56e67dff6126946d2c9c92d8bc5f436b82552d99dca14072f37f2f360ca567#rd

4.https://ash.confex.com/ash/2024/webprogram/Paper206408.html

5. https://ashpublications.org/blood/article/140/Supplement%201/4625/491174/The-Safety-and-Efficacy-of-p-CAR-19B-a-Scfv