Cov ntaub ntawv thoob ntiaj teb theem III ntawm ivosidenib ua ke nrog azacitidine rau thawj txoj kab kev kho mob ntawm IDH1 hloov pauv mob myeloid leukemia

Thaum Lub Yim Hli 4, CStone tus koom tes thoob ntiaj teb kev lag luam kws tshuaj Servier tshaj tawm tias ivosidenib thiab tshuaj siv tshuaj kho mob Azacitidine tau siv los kho IDH1 yav dhau los tsis kho tus mob myeloid leukemia (AML) cov neeg laus nrog ntiaj teb theem III ob-dig muag placebo tswj AGILE txoj kev tshawb fawb mus txog qhov kawg ntawm kev tshwm sim tsis pub muaj sia nyob (EFS). Qhov no txhais tau tias ivosidenib yog thawj qhov kev kho mob uas ua ke nrog azacitidine nrog azacitidine txhawm rau txhim kho kev muaj sia nyob tsis muaj xwm txheej thiab muaj sia nyob tag nrho.

Piv nrog azacitidine ua ke nrog cov placebo, ivosidenib ua ke nrog azacitidine kev kho mob tau ua tiav qhov kev txheeb cais tseem ceeb hauv EFS. Ib qho ntxiv, kev sim mus txog tag nrho nws cov ntsiab lus tseem ceeb thib ob, suav nrog kev tshem tawm tag nrho (CR) tus nqi, kev muaj sia nyob tag nrho (OS), CR thiab kev tshem tawm tag nrho (CRh) tus nqi nrog rau ib nrab ntawm kev rov ua haujlwm hematological, thiab lub hom phiaj kev zam txim (ORR). Kev nyab xeeb ntawm ivosidenib ua ke nrog Azacitidine zoo ib yam nrog cov ntaub ntawv tshaj tawm yav dhau los. Hauv kev pom ntawm qhov sib txawv ntawm qhov tseem ceeb ntawm kev kho mob ntawm pab pawg kho mob thiab pab pawg tswj hwm, raws li kev pom zoo ntawm Pawg Saib Xyuas Cov Ntaub Ntawv Ywj Pheej (IDMC), txoj kev tshawb fawb tau nres ntxov thaum yav tom ntej.

Cov ntaub ntawv ntxaws ntxaws ntawm AGILE kev tshawb fawb yuav tshaj tawm rau yav tom ntej kev kawm sablaj. Cov txiaj ntsig ntawm qhov kev tshawb fawb no tseem yuav muab qhia thiab sib tham nrog zej zog kho mob thoob ntiaj teb thiab cov koom haum tswj hwm.

Thaum Lub Xya Hli 19, 2019, CStone Pharmaceuticals tshaj tawm tias AGILE, kev sau npe thoob ntiaj teb theem III sim, tau ua tiav thawj qhov kev tswj hwm tus neeg mob hauv Suav teb. Txog tam sim no, tag nrho 12 lub chaw hauv Suav teb tau koom nrog AGILE kev tshawb fawb.

Xibfwb Wang Jianxiang, tus kws tshawb fawb Suav ntawm AGILE txoj kev tshawb fawb thiab Tsev Kho Mob ntawm Hematology ntawm Suav Academy ntawm Kev Kho Mob Kev Tshawb Fawb, tau hais tias: "Kev kwv yees ntawm cov neeg laus thiab tshiab tau kuaj pom tus mob myeloid leukemia uas tsis haum rau kev siv tshuaj kho mob hnyav yog qhov tsis zoo, thiab cov kev xaiv kho mob tshiab thiab zoo yog xav tau kho mob sai. Cov txiaj ntsig tau zoo ntawm AGILE Nws yog qhov tseem ceeb rau cov neeg mob IDH1 hloov pauv mob myeloid mob qog noj ntshav uas tsis tau txais kev kho mob, thiab coj kev cia siab tshiab rau kev txhim kho kev kwv yees ntawm cov neeg mob no."

Dr. Yang Jianxin, Tus Thawj Saib Xyuas Kev Noj Qab Haus Huv ntawm CStone Pharmaceuticals, hais tias: "Peb zoo siab pom tias vim ivosidenib tau txais cov ntaub ntawv muaj txiaj ntsig zoo kawg nkaus, IDMC pom zoo tias kev kawm yuav tsum tau nres ntxov. Kev ua tiav ntawm AGILE txoj kev kawm yog qhov kev kov yeej loj hauv thaj chaw AML. Ntawm cov neeg kuaj mob tshiab IDH1 hloov pauv AML cov neeg mob uas tsis tsim nyog rau kev kho mob hnyav, ivosidenib ua ke nrog Azacitidine ua tiav kev txheeb cais tseem ceeb hauv thawj qhov kawg EFS thiab txhua qhov tseem ceeb thib ob qhov kawg. Peb ua tsaug txhua tus neeg tshawb nrhiav thiab cov ncauj lus uas koom nrog AGILE txoj kev tshawb fawb Thiab cov neeg hauv tsev neeg, thiab peb npaj yuav sib tham nrog National Medical Products Administration (NMPA) ntawm Tuam Tshoj kom coj txoj kev kho tshiab no rau cov neeg mob Suav sai li sai tau."

Tam sim no Ivosidenib tau pom zoo los ntawm Asmeskas Cov Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) rau kev kho mob ib leeg rau cov neeg laus uas muaj mob rov qab los lossis tsis tuaj yeem kho nrog AMH nrog IDH1 hloov pauv, nrog rau cov neeg mob tshiab uas tau kuaj pom ≥75 xyoo lossis tsis tuaj yeem siv tshuaj kho mob hnyav vim yog mob qog noj ntshav cov neeg mob nrog IDH1 hloov pauv AML. Tsis ntev los no, Asmeskas FDA tau lees paub ivosidenib Supplemental New Drug Application (sNDA) ua qhov muaj peev xwm kho tau rau yav dhau los kho IDH1 hloov pauv cov neeg mob cholangiocarcinoma, thiab tau txais kev tshuaj xyuas ua ntej los ntawm Asmeskas FDA.

Servier thiab CStone Pharmaceuticals txuas ntxiv ua kev koom tes tshwj xeeb hauv kev txhim kho kev kho mob thiab kev lag luam ntawm ivosidenib hauv Suav Teb Loj, suav nrog Suav Teb Loj, Hong Kong, Taiwan thiab Macau, thiab Singapore, raws li daim ntawv tso cai pom zoo.

Tam sim no, Tuam Tshoj Cov Khoom Siv Kho Mob Hauv Tebchaws tau lees txais daim ntawv thov tshuaj tshiab rau ivosidenib rau kev kho mob ntawm cov neeg laus uas muaj mob rov qab los lossis tsis tuaj yeem mob myeloid leukemia nrog IDH1 hloov pauv tau thiab suav nrog lawv hauv kev tshuaj xyuas thawj zaug.