2022 Maret: Terapi CAR-T, téhnologi CAR-T, naon Imunoterapi sél CAR-T ? Harga perawatan CAR-T, biaya, kasimpulan inpormasi rekrutmen uji klinis CAR-T panganyarna.
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 Terapi sél CAR-T ogé geus ngaliwatan sababaraha taun, tapi saprak taun ka tukang, utamana saprak satengah kadua taun ka tukang, angka nu gede ngarupakeun Terapi CAR-T have been “combined.”. Anti-cancer “new forces” are rapidly emerging.
Emily Whitehead, anak kahiji kalayan leukemia dirawat kalayan Terapi CAR-T jeung "juru bicara" terapi CAR-T, geus ngéléhkeun leukemia pikeun ampir sapuluh taun. Ayeuna terapi "kaajaiban" ieu tungtungna parantos sumping ka anjeunna sakitar pasien urang.
Ti 2021 dugi ka ayeuna, terapi CAR-T parantos nunjukkeun tren akumulasi, sareng seueur produk anu diluncurkeun hiji-hiji. Salila periode ieu, nagara kuring parantos ngalaksanakeun 3 terapi CAR-T sacara berturut-turut, ngamungkinkeun pasien ningali subuh tina program énggal.
Liso-Cel
(Lisocabtagene maraleucel, Breyanzi)
Status: Disatujuan pikeun pamasaran (FDA)
Nalika: Pébruari 6, 2021
Perkenalan: Liso-Cel mangrupikeun terapi anti CD19 dumasar kana sél T pasien sorangan.
Indications: Large B-cell lymphoma (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)
Relevan percobaan klinis jeung data:
[TRANSCEND NHL 001 sidang (NCT02631044)] Pikeun penderita dirawat kalayan Liso-Cel, laju remisi sakabéh éta 73%, nu laju remisi lengkep éta saluhur 53%; Pasién tiasa ngahontal remisi munggaran atanapi remisi parsial saatos sakitar 1 bulan perlakuan.
Dina median nurutan-up 12 bulan, 54.7% pasien tetep dina remisi klinis; penderita miboga survival progression bébas median 6.8 bulan sarta survival sakabéh median 21.1 bulan; Pasién ngagaduhan tingkat kasalametan 1 taun 58%.
Axi-Cel
(Axicabtagene ciloleucel, Yescarta)
Status: Disatujuan pikeun pamasaran (FDA)
Nalika: 5 Maret 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 Imunoterapi sél CAR-T pikeun limfoma follicular.
Indikasi: Limfoma follicular (kambuh atanapi limfoma follicular refractory, pasien dewasa, saatos dua atanapi langkung terapi sistemik)
Relevan percobaan klinis jeung data:
[Uji coba ZUMA-5] Laju réspon sadayana ngahontal 91%, sareng tingkat réspon lengkep saluhur 60%; durasi median respon teu kahontal dina median nurutan-up of 14.5 bulan, sarta 74% pasien miboga durasi respon leuwih ti 18 bulan.
Status: Disatujuan pikeun Pamasaran (FDA, Lisensi Biologis Suplemén)
Indikasi: regimen dosis tinggi pikeun pengobatan lini kadua pasien dewasa sareng limfoma sél B kambuh / refractory.
Idé-cel
(Idecabtagene vicleucel, Abecma)
Status: Disatujuan pikeun pamasaran (FDA)
Nalika: 26 Maret 2021
bubuka: Abecma mangrupakeun autologous BCMA-diarahkeun Terapi sél T reséptor antigen chimeric (CAR). disaluyukeun tina sél T autologous pasien.
indikasi: sababaraha myeloma (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)
Uji klinis sareng data anu relevan:
[Studi multi-puseur] Laju remisi sakabéh sakabéh pasien éta 72%, nu laju remisi lengkep éta 28%; Di antara pasien anu ngahontal remisi lengkep klinis, 65% pasien ngagaduhan remisi anu lumangsung langkung ti 12 bulan.
KTE-X19
(Brexucabtagene Autoleucel, Tecartus)
Status: Disatujuan pikeun pamasaran (FDA)
Nalika: 1 Oktober 2021
Introduction: A CAR-CD19 T cell therapy previously approved for the treatment of limfoma sél mantel.
Indikasi: Leukemia limfositik B (pasien déwasa anu kambuh sareng leukemia limfositik B refrakter)
Uji klinis sareng data anu relevan:
[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..
Injeksi Yijililenxe
(Aquilon Race; Yescarta, Axicabtagene Ciloleucel, Axi-Cel; FKC876)
Status: Disatujuan pikeun Pamasaran (NMPA)
Iraha: 23 Juni 2021
Harga: 190,000 USD
Bubuka: Produk sél CAR-T munggaran diluncurkeun di Cina nyaéta terapi sél CAR-CD19-T.
Pentingna: 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 tumor, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma.
Uji klinis sareng data anu relevan: [Uji coba ZUMA-5] Laju réspon sadayana ngahontal 91%, sareng tingkat réspon lengkep saluhur 60%; durasi median respon teu kahontal dina median nurutan-up of 14.5 bulan, sarta 74% pasien miboga durasi respon leuwih ti 18 bulan.
Ruiki Orenza suntik
(Relma-cel, JWCAR029)
Status: Disatujuan pikeun Pamasaran (NMPA)
Iraha: 3 Séptémber 2021
Harga: 200,000 USD
Bubuka: Produk sél CAR-T kadua diluncurkeun di Cina, sareng ogé terapi CAR-CD19-T domestik munggaran anu resmi disatujuan pikeun pamasaran, dikembangkeun ku Shanghai WuXi Junuo.
Indikasi: Limfoma-sél B ageung (pasien sawawa sareng limfoma-sél B ageung kambuh atanapi refractory saatos terapi sistemik kadua atanapi langkung luhur)
Uji klinis sareng data anu relevan:
Laju respon sakabéh éta 60.3%.
Sidaki Aurexa suntik
(LCAR-B38M, JNJ-4528, Cilta-cel, Carvykti)
Status: Disatujuan pikeun Pamasaran (NMPA)
Nalika: Pébruari 28, 2022
Harga: US $ 465,000 / jarum
Bubuka: Produk sél CAR-T katilu anu diluncurkeun di Cina nyaéta terapi CAR-BCMA-T anu dikembangkeun ku Janssen sareng Legenda Bio.
Indications: Multiple myeloma (adult patients with relapsed/refractory multiple myeloma. Relevant clinical trials and data:
Laju respon sakabéh éta 98%, nu 83% pasien ngahontal respon lengkep ketat; laju survival bébas progression 18 bulan éta 66%, sarta laju survival bébas progression 2 taun éta 61%; tingkat survival sakabéh 18-bulan éta 81%, sarta laju survival sakabéh 2-taun éta 74%.
Salian produk anu didaptarkeun di luhur, aya deui produk sél CAR-T anu aya dina tahap pra-pasar, bertahap ngumpulkeun data uji klinis, atanapi parantos ngalebetkeun aplikasi pamasaran, sareng ngan ukur saléngkah tina pendak sareng pasien sacara resmi.
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)
Status: (FDA) Prioritas Review
Indikasi: Multiple myeloma (kambuh/refractory multiple myeloma)
bubuka: CAR-BCMA-T Terapi Cell
Uji klinis sareng data anu relevan:
[CARTITUDE-1 trial] Laju respon sakabéh éta 98%, nu 83% pasien ngahontal respon lengkep ketat; laju survival bébas progression 18 bulan éta 66%, sarta laju survival bébas progression 2 taun éta 61%; tingkat survival sakabéh 18-bulan éta 81%, sarta laju survival sakabéh 2-taun éta 74%.
ALLO-715
status: (FDA) RMAT designation, yatim Narkoba designation
Indikasi: Multiple myeloma (kambuh/refractory multiple myeloma)
bubuka: CAR-BCMA-T Terapi Cell
Uji klinis sareng data anu relevan:
Uji coba universal: Dina pasien anu nampi 3.2 × 10 ^ 6 (320 juta) infus sél CAR-T, tingkat réspon sakabéh ngahontal 60%. Jumlah rata-rata garis perawatan pikeun pasien nyaéta 5.
Kymriah
(Tisagénlecleucel)
Status: (FDA) Tinjauan Prioritas pikeun Indikasi Anyar
Indikasi: limfoma follicular (jalur kadua atanapi luhur pengobatan limfoma follicular kambuh atanapi refractory)
Perkenalan: Terapi sél CAR-CD19-T, disatujuan pikeun penderita sawawa sareng limfoma sél B ageung kambuh / refractory.
Uji klinis sareng data anu relevan:
[JULIET trial] The overall remission rate of 613 patients was 57.4%, of which 42.4% were in complete remission.
CTX110
status: (FDA) RMAT designation
Indikasi: malignancies sél B (kambuh atawa refractory CD19-positip malignancies B-sél)
bubuka: Allogeneic CAR-CD19-T Terapi Cell
Uji klinis sareng data anu relevan:
[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
Status: (FDA) Yatim Narkoba Designation
Indikasi: leukemia limfoblastik akut
Introduction: CD19/CD22 Dual Targeting Chimeric Antigen Receptor (CAR) T Cell Therapy
C-CAR039
status: (FDA) RMAT designation, lagu gancang
Indikasi: limfoma sél B badag diffuse
bubuka: CD19 / CD20 Dual Targeting Chimeric Antigen Reséptor-T Terapi Cell
Uji klinis sareng data anu relevan:
【Percobaan Fase I】 Laju réspon sakabéh pasien anu kambuh atanapi refractory diffuse lymphoma sél B ageung nyaéta 91.7%, dimana tingkat réspon lengkep nyaéta 83.3%.
CT103A
Status: (FDA) Yatim Narkoba Designation
Indikasi: multiple myeloma
bubuka: CAR-BCMA-T Terapi Cell
Uji klinis sareng data anu relevan:
[Fase I sidang] Diantara 18 penderita relapsed jeung / atawa sababaraha myeloma refractory, laju respon sakabéh CT103A éta 100%, nu 72.2% tina penderita ngahontal standar respon lengkep; laju survival bébas progression 1 taun éta 58.3%.
Liso-Cel
(Lisocabtagene maraleucel, Breyanzi)
Status: (FDA) Tinjauan Prioritas, parantos nampi aplikasi pikeun persetujuan pamasaran
bubuka: CAR-CD19-T Terapi sél
Indikasi: Limfoma-sél B ageung (pasien sawawa sareng limfoma-sél B ageung kambuh atanapi refractory anu gagal terapi lini kahiji)
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
status: (FDA) RMAT designation, yatim Narkoba designation
Indications: Gastric cancer (Claudin18.2 positive advanced gastric cancer and gastroesophageal junction adénokarsinoma)
bubuka: CAR-Claudin 18.2-T Terapi Cell
Uji klinis sareng data anu relevan:
Laju réspon sakabéh pasien nyaéta 48.6%, sareng tingkat kontrol panyakit nyaéta 73%; tingkat respon sakabéh sakabéh penderita kanker lambung éta 57.1%. Laju réspon sakabéh pasien kanker lambung anu gagal sahenteuna 2 jalur terapi dina jaman baheula nyaéta 61.1%, sareng tingkat kontrol panyakit nyaéta 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
Status: (FDA) Fast Track
indikasi: kanker tiroid (anaplastic thyroid cancer and refractory, poorly differentiated thyroid cancer)
bubuka: CAR-ICAM-1-T Terapi Cell
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.
