Maarso 2022: CAR-T therapy, farsamada CAR-T, maxay yihiin CAR-T unugyada difaaca jirka ? Qiimaha daawaynta CAR-T, qiimaha, koobitaanka macluumaadka qoritaanka tijaabada caafimaad ee ugu dambeeyay ee CAR-T.
The concept of boron neutron capture therapy has been proposed for decades, but it was not until last year that it really became popular among patients and became a hot spot; the antibody-drug conjugate (ADC), known as a “biomissile”, finally became popular last year. The research on Daaweynta unugyada CAR-T ayaa sidoo kale soo maray sannado badan, laakiin tan iyo sannadkii hore, gaar ahaan tan iyo qeybtii labaad ee sannadkii hore, tiro badan oo ah Daaweynta CAR-T have been “combined.”. Anti-cancer “new forces” are rapidly emerging.
Emily Whitehead, cunuggii ugu horreeyay ee qaba leukemia ayaa lagu daweeyay Daaweynta CAR-T iyo "Afhayeenka" daaweynta CAR-T, ayaa ka adkaaday leukemia muddo ku dhow toban sano. Hadda daawayntan "mucjisada" ayaa ugu dambeyntii u timid iyada agagaarka bukaannadayada.
Laga soo bilaabo 2021 ilaa hadda, daawaynta CAR-T waxay muujisay isbeddel urursi, iyo alaabooyin badan ayaa la bilaabay midba midka kale. Inta lagu jiro muddadan, dalkaygu wuxuu keenay 3 daawaynta CAR-T si isdaba joog ah, taasoo u oggolaanaysa bukaannada inay arkaan barriga barnaamij cusub.
Liso-Cel
(Lisocabtagene maraleucel, Breyanzi)
Xaaladda: Loo ogolaaday suuqgeyn (FDA)
Marka: Febraayo 6, 2021
Hordhac: Liso-Cel waa daawayn ka-hortagga CD19 oo ku salaysan unugyada T ee bukaanka.
Indications: Large B-cell qanjiro (adult patients with some types of large B-cell lymphoma who have not responded to at least 2 other types of systemic therapy or have relapsed after therapy)
Muhiimad Leh tijaabada caafimaadka iyo xogta:
[TRANSCEND NHL 001 trial (NCT02631044)] Bukaannada lagu daweeyay Liso-Cel, heerka guud ee cafiska wuxuu ahaa 73%, kaas oo heerka cafiska dhamaystiran uu ahaa ilaa 53%; Bukaanjiifku waxay heli karaan cafiska ugu horreeya ama cafiska qayb ahaan ka dib qiyaastii 1 bil oo daaweyn ah.
Dabagalka dhexdhexaadka ah ee bilaha 12, 54.7% bukaannadu waxay ku hareen cafis caafimaad; Bukaanadu waxay lahaayeen badbaado dhexdhexaad ah oo xor ah oo dhexdhexaad ah oo 6.8 bilood ah iyo badbaadada guud ee dhexdhexaadka ah ee bilaha 21.1; bukaanadu waxay lahaayeen heerka badbaadada 1 sano oo ah 58%.
Axi-Cel
(Axicabtagene ciloleucel, Yescarta)
Xaaladda: Loo ogolaaday suuqgeyn (FDA)
Marka: Maarso 5, 2021
Introduction: The FDA has granted Yescarta, a CAR-CD19 T cell therapy, breakthrough therapy designation and priority review for the indication of follicular lymphoma. The FDA has previously approved Yescarta’s indication for large B-cell lymphoma. After this approval, Yescarta became the first CAR-T unugyada difaaca jirka loogu talagalay lymphoma follicular.
Tilmaamaha: Lymphoma Follicular (lymphoma follicular refractory, bukaanada qaangaarka ah, ka dib laba ama ka badan oo daaweynta nidaamka ah)
Muhiimad Leh tijaabada caafimaadka iyo xogta:
[ZUMA-5 tijaabada] Heerka jawaabta guud waxa uu gaadhay 91%, heerka jawaab celinta oo dhamaystiranna waxa uu ahaa ilaa 60%; Muddada dhexdhexaadka ah ee jawaabta laguma gaarin dabagal dhexdhexaad ah oo bilaha 14.5 ah, iyo 74% bukaannada ayaa lahaa muddada jawaabta in ka badan 18 bilood.
Xaaladda: Loo ogolaaday Suuqgeynta (FDA, Shatiga Dheeraadka ah ee Biyolojiga)
Tilmaan: Dawaynta qiyaasta sare ee daawaynta safka labaad ee bukaanada qaangaarka ah ee dib u soo noqday/cell B-cell lymfoma
Ide-cel
(Idecabtagene vicleucel, Abecma)
Xaaladda: Loo ogolaaday suuqgeyn (FDA)
Marka: Maarso 26, 2021
Horudhac: Abecma waa autologous ay hagto BCMA daawaynta unugyada chimeric antigen receptor (CAR). laga soo qaatay unugyada T-da ee iswada ee bukaanka.
Tilmaamaha: Meelo badan (adult patients with relapsed or refractory multiple myeloma who have received 4 or more lines of therapy, including immunomodulators, proteasome inhibitors and CD38 monoclonal antibodies)
Tijaabooyin iyo xog caafimaad oo khuseeya:
[Daraasad xarumo badan leh] Guud ahaan heerka cafiska ee dhammaan bukaannada wuxuu ahaa 72%, kaas oo heerka cafis dhammaystiran uu ahaa 28%; Bukaannada helay cafis dhammaystiran oo bukaan-socod ah, 65% bukaannada ayaa helay cafis taasoo socotay in ka badan 12 bilood.
KTE-X19
(Brexucabtagene Autoleucel, Tecartus)
Xaaladda: Loo ogolaaday suuqgeyn (FDA)
Marka: Oktoobar 1, 2021
Introduction: A CAR-CD19 T cell therapy previously approved for the treatment of lymphoma unugga mantle.
Tilmaamaha: B lymphocytic leukemia (bukaanada qaangaarka ah ee soo noqnoqda iyo leukemia B lymphocytic)
Tijaabooyin iyo xog caafimaad oo khuseeya:
[ZUMA-3 trial] The complete remission rate was 56.4%, and 14.5% of patients achieved clinical complete remission. Only the blood counts did not return to normal, that is, CRi was achieved; the median progression-free survival was 11.6 months, and the median overall survival was 18.2 months. Patients who achieved clinical complete remission (including blood counts that did not return to normal) had a median progression-free survival of 14.2 months and had the shortest overall survival of 16.2 months; for those who did not, the median overall survival was only 2.4 months..
Cirridka Yijililenxe
(Aquilon Race; Yescarta, Axicabtagene Ciloleucel, Axi-Cel; FKC876)
Xaaladda: Loo ogolaaday Suuqgeynta (NMPA)
Marka: Juun 23, 2021
Qiimaha: 190,000 USD
Hordhac: Alaabtii ugu horreysay ee CAR-T ee laga bilaabay Shiinaha waa daawaynta unugyada CAR-CD19-T.
Muhiim: For adults with relapsed or refractory large B-cell lymphoma after receiving second-line or above standard therapy, this medicine is indicated. It can be used for diffuse large B-cell lymphoma unspecified, primary mediastinal B-cell carcinoma lymphoma buro, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma.
Tijaabooyin iyo xog caafimaad oo khuseeya: [ZUMA-5 tijaabada] Heerka jawaabta guud waxa uu gaadhay 91%, heerka jawaab celinta oo dhamaystiranna waxa uu ahaa ilaa 60%; Muddada dhexdhexaadka ah ee jawaabta laguma gaarin dabagal dhexdhexaad ah oo bilaha 14.5 ah, iyo 74% bukaannada ayaa lahaa muddada jawaabta in ka badan 18 bilood.
Ruiki Orenza Cirbad
(Relma-cel, JWCAR029)
Xaaladda: Loo ogolaaday Suuqgeynta (NMPA)
Marka: Sebtembar 3, 2021
Qiimaha: 200,000 USD
Hordhac: Badeecada labaad ee CAR-T ee laga bilaabay Shiinaha, iyo sidoo kale daawaynta ugu horreysa ee CAR-CD19-T ee si rasmi ah loogu oggolaaday suuqgeynta, waxaa sameeyay Shanghai WuXi Junuo.
Tilmaamaha: Large B-cell lymfoma (bukaanada qaangaarka ah ee leh dib u soo noqoshada ama dib-u-kicinta weyn ee B-cell lymfoma ka dib markii daawaynta nidaamka labaad ama ka sarreeya)
Tijaabooyin iyo xog caafimaad oo khuseeya:
Heerka jawaabta guud wuxuu ahaa 60.3%.
Sidaki Aurexa cirbadeynta
(LCAR-B38M, JNJ-4528, Cilta-cel, Carvykti)
Xaaladda: Loo ogolaaday Suuqgeynta (NMPA)
Marka: Febraayo 28, 2022
Qiimaha: US$465,000/ irbad
Hordhac: Alaabta saddexaad ee CAR-T ee laga bilaabay Shiinaha waa daawaynta CAR-BCMA-T oo ay si wadajir ah u soo saareen Janssen iyo Legend Bio.
Indications: Multiple myeloma (adult patients with relapsed/refractory multiple myeloma. Relevant clinical trials and data:
Heerka jawaabta guud wuxuu ahaa 98%, kuwaas oo 83% bukaannada ay heleen jawaab celin dhamaystiran oo adag; heerka badbaadada ee bilaa horumarka ah ee 18-bilood ah waxa uu ahaa 66%, iyo heerka badbaadada bilaa horumarka ee 2-sano waxa uu ahaa 61%; heerka badbaadada guud ee 18-bilood wuxuu ahaa 81 %, iyo 2-da sano ee guud ahaan heerka badbaadadu wuxuu ahaa 74%.
Marka lagu daro alaabooyinka kor ku xusan, waxaa jira badeecooyin badan oo CAR-T ah kuwaas oo ku jira marxaladda suuqa ka hor, si tartiib tartiib ah u ururinaya xogta tijaabada caafimaadka, ama soo gudbiyay codsi suuqgeyn, oo kaliya hal tallaabo u jirta la kulanka bukaanada.
Among them, there are many “rookies” with potential as much as the marketed products, and during this period they have obtained various FDA licenses or “titles,” such as orphan drug designation, fast track qualification, advanced regenerative immune therapy, and so on.
Cilta-cel
(Ciltacabtagene autoleucel, domestic name: Ciltacabtagene autoleucel injection)
Xaaladda: (FDA) Dib u eegis mudnaanta leh
Tilmaamaha: Myeloma badan (soo laabasho/dib u noqosho badan myeloma)
Hordhac: CAR-BCMA-T Daaweynta Unugyada
Tijaabooyin iyo xog caafimaad oo khuseeya:
[CARTITUDE-1 trial] Heerka jawaabta guud wuxuu ahaa 98%, kuwaas oo 83% bukaanada ay heleen jawaab celin dhamaystiran; heerka badbaadada ee bilaa horumarka ah ee 18-bilood ah waxa uu ahaa 66%, iyo heerka badbaadada bilaa horumarka ee 2-sano waxa uu ahaa 61%; heerka badbaadada guud ee 18-bilood wuxuu ahaa 81 %, iyo 2-da sano ee guud ahaan heerka badbaadadu wuxuu ahaa 74%.
ALLO-715
Heerka: (FDA) Magacaabista RMAT, Magacaabidda Dawooyinka Agoonta
Tilmaamaha: Myeloma badan (soo laabasho/dib u noqosho badan myeloma)
Hordhac: CAR-BCMA-T Daaweynta Unugyada
Tijaabooyin iyo xog caafimaad oo khuseeya:
Tijaabada UNIVERSAL: Bukaannada helay 3.2 × 10 ^ 6 (320 milyan) faleebooyin unug CAR-T ah, heerka jawaab celinta guud ayaa gaadhay 60%. Tirada dhexdhexaadka ah ee khadadka daawaynta ee bukaanku waxay ahaayeen 5.
Kymiah
(Tisagenlecleucel)
Xaaladda: (FDA) Mudnaanta Mudnaanta ee Tilmaamaha Cusub
Tilmaamaha: lymphoma follicular (daawaynta labaad ama ka sareysa ee lymphoma follicular soo laabatay ama refractory)
Hordhac: CAR-CD19-T daawaynta unug, oo loo ogolaaday bukaanada qaangaarka ah ee dib u soo noqday/celid weyn oo B-cell lymphoma
Tijaabooyin iyo xog caafimaad oo khuseeya:
[JULIET trial] The overall remission rate of 613 patients was 57.4%, of which 42.4% were in complete remission.
CTX110
Xaaladda: (FDA) Magacaabista RMAT
Tilmaamaha: Malignancies B-unugga (soo noqoshada ama dib u soo noqoshada CD19-positive B-cell malignancies)
Hordhac: Allogeneic CAR-CD19-T Cell Therapy
Tijaabooyin iyo xog caafimaad oo khuseeya:
[CARBON Trial] Among 24 patients who met the intention-to-treat criteria, the overall response rate of CTX110 in the second dose group was 58%, including 38% of patients who achieved a clinically complete response.
CT120
Heerka: (FDA) Magacaabidda Dawooyinka Agoonta
Tilmaam: Lymphoblastic lymphoblastic leukemia
Introduction: CD19/CD22 Dual Targeting Chimeric Antigen Receptor (CAR) T Cell Therapy
C-CAR039
Heerka: (FDA) Magacaabista RMAT, Track Fast
Tilmaamaha: Kala firdhiso lymfoma B-cell weyn
Horudhac: CD19/CD20 Labada Beegsiga ee Chimeric Antigen Receptor-T Cell Therapy
Tijaabooyin iyo xog caafimaad oo khuseeya:
【Tijaabada Wajiga 91.7aad】 Heerka jawaabta guud ee bukaanada soo noqnoqday ama soo noqnoqday ee limfoma-ga weyn ee B-cell waxay ahayd 83.3%, kaas oo heerka jawaab celinta oo dhamaystiran uu ahaa XNUMX%.
CT103A
Heerka: (FDA) Magacaabidda Dawooyinka Agoonta
Tilmaam: Multiple myeloma
Hordhac: CAR-BCMA-T Daaweynta Unugyada
Tijaabooyin iyo xog caafimaad oo khuseeya:
[Tijaabada Wajiga I] Ka mid ah bukaannada 18 ee qaba dib-u-soo-kabashada iyo / ama dib-u-celinta badan ee myeloma, heerka jawaabta guud ee CT103A wuxuu ahaa 100%, kaas oo 72.2% bukaannadu ay gaadheen heerka jawaab-celinta dhamaystiran; heerka badbaadada ee bilaa horumarka ah ee 1 sano ah waxa uu ahaa 58.3 %.
Liso-Cel
(Lisocabtagene maraleucel, Breyanzi)
Xaaladda: (FDA) Dib u eegis mudnaanta leh, ayaa aqbashay codsiga oggolaanshaha suuqgeyn
Hordhac: CAR-CD19-T Daaweynta Unugyada
Tilmaan: Large B-cell lymphoma (bukaanada qaangaarka ah ee soo noqnoqday ama soo noqnoqda ee lymphoma weyn ee B-cell kuwaas oo ku guuldareystay daaweynta safka hore)
So far, all CAR-T cell therapies that have been marketed have targeted various types of hematological tumors. Even if promising therapies are included, there are very few projects targeting solid tumors. It is so difficult for CAR-T therapy to break through solid tumors, and only a few “elites” can be on this most difficult “battlefield.”.
CT041
Heerka: (FDA) Magacaabista RMAT, Magacaabidda Dawooyinka Agoonta
Indications: Gastric cancer (Claudin18.2 positive advanced gastric cancer and gastroesophageal junction adenocarcinoma)
Hordhac: CAR-Claudin 18.2-T daawaynta unugyada
Tijaabooyin iyo xog caafimaad oo khuseeya:
Heerka jawaabta guud ee dhammaan bukaannada ayaa ahaa 48.6%, heerka xakamaynta cudurkuna wuxuu ahaa 73%; heerka jawaabta guud ee dhammaan bukaannada kansarka caloosha ayaa ahaa 57.1%. Heerka jawaabta guud ee bukaannada kansarka caloosha ee ku guul daraystay ugu yaraan 2 khadadka daawaynta ee la soo dhaafay waxay ahayd 61.1%, heerka xakamaynta cudurkuna wuxuu ahaa 83.3%.
There is no doubt that CT041 is one of the most advanced and effective regimens among all CAR-T cell therapies for solid tumors. At present, this program is still recruiting subjects, and patients who have the opportunity to try it must not miss it!
AIC100
Xaalada: (FDA) Track Track
Tilmaamaha: Kansarka qanjirka (anaplastic thyroid cancer and refractory, poorly differentiated thyroid cancer)
Hordhac: CAR-ICAM-1-T Daaweynta Unugyada
There are three CAR-T products currently listed in China: one is 1.2 million per injection, the other is 1.29 million per injection, and the third is US$465,000 per injection. For the vast majority of patients, i’s an unbearable price.
The cost of CAR-T therapy is obviously expensive, but at the same time, my country is the country with the largest number of CAR-T cell therapy research and clinical trials, and a large number of domestic centers are recruiting Chinese patients for trial projects. For patients who meet the needs of the indication, this is a good channel to enjoy new drug treatments in advance and avoid huge expenses.
