Thaum Lub Peb Hlis 5, 2025, Ascentage Pharma tshaj tawm tias nws cov tshuaj, olverembatinib, tau txais Kev Tsim Kho Tshiab (BTD) los ntawm Lub Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Tuam Tshoj Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA), rau kev sib xyaw nrog kev kho mob chemotherapy qis qis rau kev kho mob thawj kab ntawm cov neeg mob tshiab uas muaj Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
Qhov no yog BTD thib peb uas tau muab rau olverembatinib hauv Suav teb, nrog rau BTD thawj zaug tau muab rau lub Peb Hlis 2021, rau kev kho mob rau cov neeg mob uas muaj mob chronic myeloid leukemia (CML-CP) uas tiv taus thiab/lossis tsis kam rau thawj thiab tiam thib ob tyrosine kinase inhibitors (TKIs); thiab BTD thib ob tau muab rau lub Rau Hli 2023, rau kev kho mob rau cov neeg mob uas muaj succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) uas tau txais kev kho mob thawj kab.
Tshaj tawm ntawm Lub Rooj Sib Tham Txhua Xyoo 66th ntawm American Society of Hematology (ASH) Kev Nyab Xeeb thiab Kev Ua Haujlwm ntawm Olverembatinib (HQP1351) Ua Ke nrog Lisaftoclax (APG-2575) hauv Cov Menyuam Yaus thiab Cov Hluas uas Muaj Mob Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (R/R Ph ALL): Daim Ntawv Qhia Thawj Zaug los ntawm Kev Kawm Theem 1.
Olverembatinib, yog ib hom tshuaj TKI tiam thib peb tshiab, uas siv tau zoo thiab muaj zog tiv thaiv kab mob qog ntshav hauv cov menyuam yaus uas muaj CP-CML kho mob ntau zaus nrog lossis tsis muaj T315I mutation. Kev tshawb nrhiav txog lisaftoclax, yog ib hom tshuaj BCL-2 inhibitor tshiab, tau pom tias muaj txiaj ntsig zoo rau kev tiv thaiv qog ntshav hauv cov menyuam yaus uas muaj ntau yam kab mob ntshav. Tam sim no, tsis muaj kev kho mob zoo rau cov menyuam yaus uas muaj R/R Ph+ ALL. Kev tshawb fawb no tau tsim los tshawb nrhiav kev nyab xeeb, kev ua tau zoo, thiab pharmacokinetic (PK) profile ntawm olverembatinib ib leeg lossis ua ke nrog lisaftoclax hauv cov menyuam yaus thiab cov hluas uas muaj R/R Ph ALL.+
Qhov no yog kev tshawb nrhiav qhib, theem 1b (NCT05495035) uas tau sau npe cov menyuam yaus thiab cov hluas hnub nyoog qis dua 18 xyoo uas tiv taus R/R Ph ALL lossis tsis kam rau tsawg kawg 1 tyrosine kinase inhibitor (TKI) (kev siv TKIs ua ntej tsis tau txiav txim siab yog tias pts muaj T315I mutation). Pts yuav tsum muaj qhov qhab nia Karnofsky/Lansky kev ua tau zoo thiab kev ua haujlwm ntawm lub cev. Pts nrog cov tsos mob ntawm cov kab mob hauv lub paj hlwb lossis los ntshav ntau, uas tsis muaj feem cuam tshuam rau PhALL, raug tshem tawm. Olverembatinib tau noj ntawm 40 mg tus neeg laus sib npaug koob tshuaj (AED) txhua ob hnub rau 2 lub lis piam (Hnub [D] 1-14), ua raws li tib koob tshuaj ntawm olverembatinib ua ke nrog lisaftoclax ntawm koob tshuaj 200/400/600 mg (AED) txhua hnub (QD) rau D13-42 (xav tau 3-hnub koob tshuaj nce ntxiv los ntawm D13-15). Dexamethasone 6 mg/m++ 2/hnub tau muab noj rau hauv qhov ncauj QD txij hnub tim 15-42. Cov ntsiab lus tseem ceeb kawg suav nrog kev ntsuam xyuas kev nyab xeeb, tus nqi teb tag nrho (ORR), tus nqi tsis zoo ntawm cov kab mob seem uas ntsuas tau (MRD), thiab cov yam ntxwv PK ntawm olverembatinib ib leeg/ua ke nrog lisaftoclax.
Txij lub Cuaj Hli 2022 txog rau Lub Rau Hli 2024, tag nrho muaj 10 pts tau sau npe. Lub hnub nyoog nruab nrab (ntau yam) yog 13.0 (11-15) xyoo, thiab 6 pts yog txiv neej. Lub cev nruab nrab (ntau yam) qhov hnyav yog 49.85 (35.9-86.0) kg. Cuaj (90.0%) pts tau qhia txog p190 transcript thiab 1 pt (10.0%) tau qhia txog p210 transcript. Peb pts tau muaj BCR-ABL1 mutations [2, T315I; 1, F317L (c.951C>A)] thaum pib. Tom qab 1 pt raug tso tseg ntawm kev sim vim muaj kev qaug dab peg ntawm D1 ntawm Chav Kawm 1 (C1D1), 9 pt tsim nyog tau suav nrog hauv tus qauv nce koob tshuaj 3 + 3 (n = 6, R / R; n = 3, tsis kam): 3 pts hauv txhua Caj Npab (A, B, thiab C) ntawm cov koob tshuaj lisaftoclax uas tau muab faib ua 200, 400, thiab 600 mg (AED), raws li. Cov pts no ua tiav 42 hnub ntawm kev kho mob thiab tau soj ntsuam rau cov ntsiab lus kawg tseem ceeb. Rau ntawm 10 pts tau ntsib qib ≥ 3 kev kho mob ntshav-cov xwm txheej tsis zoo, suav nrog anemia (3/10), neutropenia (7/10), thiab thrombocytopenia (3/10); 1 pt muaj qib 3 alanine aminotransferase nce ua rau kev kho mob raug tso tseg, thiab 1 pt muaj qaug dab peg ntawm C1D1 (leej twg tau tso tseg kev sim). Ntawm 6 cov qhab nia uas ntsuas tau rau cov lus teb morphologic, ORR (kev zam txim tiav [CR] + CR nrog kev rov qab suav tsis tiav), cov lus teb ib nrab, thiab tsis muaj lus teb yog, raws li, 2 (33.3%), 2 (33.3%), thiab 2 (33.3%) thaum kawg ntawm olverembatinib monotherapy (EOM) thiab 5 (83.3%), 0, thiab 1 (16.7%) thaum kawg ntawm olverembatinib thiab lisaftoclax ua ke (EOC). Tsib ntawm 7 cov qhab nia uas ntsuas tau tau ua tiav MRD tsis zoo, uas 1 yog ntawm EOM thiab 4 ntawm EOC. Kev tshuaj xyuas PK ua ntej qhia txog cov yam ntxwv PK zoo sib xws thiab kev sib piv ntawm cov menyuam yaus thiab cov neeg laus rau olverembatinib thiab lisaftoclax. Tsis muaj kev sib sau ua ke tseem ceeb tom qab ntau koob tshuaj, thiab tsis muaj kev sib cuam tshuam tshuaj-tshuaj tau pom ntawm olverembatinib thiab lisaftoclax.
Cov ntaub ntawv pib no qhia tau tias olverembatinib ua ke nrog lisaftoclax zoo li yog ib txoj kev kho mob zoo thiab muaj kev nyab xeeb rau cov neeg mob uas muaj R/R Ph ALL. Txoj kev kho mob no ua rau muaj kev cia siab tias CR yuav zoo yam tsis tas siv tshuaj kho mob hnyav lossis tshuaj kho mob tiv thaiv kab mob. Txoj kev tshawb fawb no tam sim no nyob rau theem kev nthuav dav ntawm cov tshuaj.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Cov ntaub ntawv siv los ua piv txwv
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.发现和开发一流的小分子癌症疗法的领导者 - (ascentage.com)
Lub sijhawm tshaj tawm: Lub Peb Hlis-12-2025