Cstone Pharmaceuticals ESMO tshaj tawm Ivosidenib AML Tuam Tshoj Kev Tshawb Fawb Cov Ntaub Ntawv, IDH1 Mutant Tumors Usher hauv Kev Kho Tshiab

Mob myeloid leukemia (AML) yog hom mob ntshav qab zib ntau tshaj plaws thiab paub tias yog" npau suav phem" ntawm cov neeg laus thiab cov laus. Hauv Tebchaws Meskas, muaj txog 20,000 tus neeg mob tshiab txhua xyoo, thiab cov neeg mob muaj sia nyob tsib xyoos yog 29%.

Mob myeloid leukemia (AML) yog hom mob ntshav qab zib ntau tshaj plaws thiab paub tias yog" npau suav phem" ntawm cov neeg laus thiab cov laus. Hauv Tebchaws Meskas, muaj txog 20,000 tus neeg mob tshiab txhua xyoo, thiab cov neeg mob muaj sia nyob tsib xyoos yog 29%. Hauv Suav teb, nrog kev laus ntawm cov pejxeem, qhov xwm txheej ntawm tus kabmob hauv Suav teb kuj tseem nce xyoo los ntawm xyoo. Kwv yees li 6-10% ntawm AML cov neeg mob uas muaj tus mob tshiab txhua xyoo muaj kev hloov pauv IDH1, thiab tam sim no tsis muaj cov neeg kho mob hauv Suav teb. Targeted tshuaj rau AML cov neeg mob raug rau IDH1 kev hloov pauv. Yog li ntawd, cov kev kho mob tshiab thiab kev tshawb fawb txog tus kab mob no kuj tau nyiam ntau yam hauv kev lag luam.

Tsis ntev los no, ntawm 2021 European Society of Medical Oncology (ESMO) lub rooj sib tham txhua xyoo, Cstone Pharmaceuticals tau tshaj tawm cov ntaub ntawv kho mob ntawm Ivosidenib Tuam Tshoj Cov Ntawv Sau Npe Kawm Bridging CS3010-101 hauv daim ntawv qhia qhov ncauj nyiam. Cov ntaub ntawv qhia tau hais tias Ivosidenib muaj txiaj ntsig zoo hauv kev kho mob ntawm isocitrate dehydrogenase 1 (IDH1) mutated neeg laus rov qab los lossis refractory mob myeloid leukemia (R / R AML) Suav cov neeg mob tau pom tias muaj txiaj ntsig zoo heev, kev zam zoo, thiab kev nyab xeeb.

Qhov no kuj yog cov ntaub ntawv kawm thib peb uas tau tshaj tawm los ntawm Cstone Pharmaceuticals ntawm lub rooj sib tham ESMO no. Thawj ob yog cov txiaj ntsig ntawm kev tshawb fawb blockbuster ntawm cov piam thaj rau theem III NSCLC cov neeg mob, thiab CS1002 (CTLA-4 monoclonal antibody). ) Cov txiaj ntsig ua ntej ntawm Phase Ib txoj kev tshawb fawb ntawm kev kho mob ua ke nrog CS1003 (PD-1 monoclonal antibody) hauv cov neeg mob uas muaj cov qog nqaij hlav siab heev.

IvosidenibAML Suav bridging kev tshawb fawb cov ntaub ntawv zoo siab heev

Nws tau nkag siab tias CS3010-101 txoj kev tshawb fawb tso tawm lub sijhawm no yog theem I, ntau qhov chaw, ib sab caj npab kawm tau ua nyob rau hauv Suav teb los ntsuas cov tshuaj pharmacokinetic ntawm Ivosidenib hauv kev kho qhov ncauj ntawm cov neeg laus R / R AML cov neeg mob nrog IDH1 kev hloov pauv. . Pharmacodynamic yam ntxwv, kev nyab xeeb thiab kev kho mob ua tau zoo, thiab raws li kev sib txuas ntawm kev tshawb fawb thoob ntiaj teb tseem ceeb AG120-C-001, muab cov ntaub ntawv ntawm R / R AML cov neeg mob hauv Suav teb.

Cov txiaj ntsig ntawm txoj kev tshawb fawb pom tau tias 36.7% ntawm cov neeg mob tau mus txog qhov kawg ntawm qhov ua tau zoo, ua tiav kev tshem tawm thiab ua tiav kev tshem tawm nrog ib nrab hematological rov qab (CR+CRh); qhov nruab nrab qhov kev muaj sia nyob tsis pub muaj sia nyob (EFS) yog 5.52 lub hlis, Qhov nruab nrab tag nrho cov ciaj sia taus (OS) mus txog 9.1 lub hlis; kev nyab xeeb yog qhov zoo, thiab tsis pom muaj kev nyab xeeb tshiab.

Xib fwb Wang Jianxiang, tus kws tshawb fawb tseem ceeb ntawm CS3010-101 thiab Hematology Tsev Kho Mob ntawm Suav Academy ntawm Kev Tshawb Fawb Txog Kev Kho Mob, tau hais tias, "Peb zoo siab heev uas pom tias nws txoj kev tshawb fawb hauv Suav teb tau ua tiav cov txiaj ntsig xav tau thiab ua tau zoo thiab muaj kev nyab xeeb. Peb tos ntsoov yuav muaj txiaj ntsig zoo rau Tuam Tshoj cov neeg mob AML."

Raws li qhov kev tshawb fawb no, thaum Lub Yim Hli xyoo no, Lub Chaw Ntsuam Xyuas Tshuaj ntawm Tuam Tshoj Cov Khoom Siv Kho Mob Kev Tswj Xyuas tau lees txais Ivosidenib' daim ntawv thov tshuaj tshiab rau kev kho tus neeg laus R/R AML nrog rau kev hloov pauv IDH1 thiab suav nrog hauv saib xyuas qhov tseem ceeb. Xyoo 2020, Ivosidenib tau suav nrog hauv Suav teb' s" Kev Kho Mob Nthuav Txog Cov Tshuaj Kho Mob Tshiab Hauv Tebchaws Meskas (Third Batch)", thiab kuj tau suav nrog hauv 2020 version ntawm" Tuam Tshoj Clinical Tumor Association Cov Lus Qhia rau Kev Ntsuas thiab Kev Kho Mob Ntawm Cov Kab Mob Hematological".

Dr. Yang Jianxin, Tus Thawj Saib Xyuas Kev Kho Mob ntawm Cstone Pharmaceuticals, tau hais tias cov ntaub ntawv zoo heev ntawm Ivosidenib hauv kev kho mob ntawm cov neeg mob Suav tau nthuav tawm hauv daim ntawv tshaj tawm qhov ncauj nyiam ntawm ESMO lub rooj sib tham txhua xyoo, uas yog kev lees paub siab ntawm Ivosidenib los ntawm thoob ntiaj teb kev kawm zej zog." Peb yuav ua haujlwm ze nrog NMPA thiab tos ntsoov yuav nqa cov tshuaj tshiab thib peb ntawm nws zoo rau cov neeg mob Suav sai li sai tau tom qab Pugethua® thiab Taijihua®."

Ivosidenib yog lub ntiaj teb' thawj lub zog qhov ncauj qhov ncauj inhibitor rau IDH1 mutant qog noj ntshav. Nws tau raug pom zoo hauv Tebchaws Meskas rau ob qhov kev qhia, suav nrog kev kho tus neeg laus ib leeg ntawm cov neeg laus R / R AML cov neeg mob nrog IDH1 cov kev hloov pauv hloov tau thiab cov kev kuaj mob tshiab Cov neeg laus AML cov neeg mob IDH1 muaj kev hloov pauv uas muaj hnub nyoog ≥75 xyoos lossis tsis tuaj yeem siv tshuaj kho mob hnyav vim mus rau lwm yam comorbidities, thiab siv rau hauv zos advanced los yog metastatic IDH1 kev hloov pauv uas tau kho yav dhau los nrog IDH1 kev hloov pauv tau pom los ntawm FDA-pom zoo nrhiav pom cov neeg laus cov neeg mob cholangiocarcinoma. Kev lag luam cia siab tias Ivosidenib yuav raug pom zoo rau thawj qhov qhia hauv Suav teb hauv lub quarter thib plaub ntawm lub xyoo no lossis thawj peb lub hlis twg ntawm xyoo tom ntej.

Ua kom nthuav dav AML thawj kab kev kho mob thiab xa mus rau lwm hom mob qog noj ntshav

Kev nthuav dav ntawm cov cim qhia qhia txog kev lag luam loj loj

Qhov tseeb, hauv thaj tsam ntawm AML, Ivosidenib kuj tau ua tiav tseem ceeb raws li kev kho thawj zaug ntxiv rau nws siv rau cov neeg mob rov qab los thiab rov ua dua.

Thaum lub Yim Hli xyoo no, lub ntiaj teb theem III ob qhov muag tsis pom kev placebo-tswj AGILE txoj kev tshawb fawb ntawm Ivosidenib ua ke nrog cov tshuaj kho mob azacitidine hauv kev kho mob ntawm cov neeg laus uas tsis tau kho yav dhau los nrog IDH1 mutant AML tau mus txog qhov kawg ntawm EFS. Raws li 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 los ntawm Pawg Neeg Saib Xyuas Cov Ntaub Ntawv Independent (IDMC), txoj kev tshawb fawb tau nres thaum ntxov nyob rau yav tom ntej.

Ntxiv nrog rau AML, Ivosidenib kuj tau ua rau muaj kev cuam tshuam hauv lwm cov kev qhia, suav nrog ntau qhov chaw xws li qib siab glioma thiab cholangiocarcinoma. Ntawm lawv, nws yog siv los kho cov neeg laus cov neeg mob uas rov qab los thiab refractory myelodysplastic syndrome (MDS) nqa IDH1 hloov pauv tau yooj yim, thiab nws kuj tau lees paub tias yog" kev kho mob" nyob rau hauv lub tebchaws United States.

Tsis tas li ntawd xwb, hauv kev sim pob tawb ntawm Ivosidenib, cov ntaub ntawv los ntawm ib pawg ntawm cov neeg mob nrog IDH1 mutant advanced glioma qhia tau hais tias muaj kev nyab xeeb zoo, kev tswj kab mob mus sij hawm ntev, thiab txo cov qog loj hlob. Nws tau nkag siab tias tus naj npawb ntawm cov neeg tuag vim yog glioma hauv Suav teb nce mus txog 30,000 txhua xyoo, thiab qhov tshwm sim ntawm IDH1 hloov pauv hauv cov neeg mob glioma yog siab heev. Hauv cov neeg mob glioma qib qis thiab cov neeg mob ntshav qab zib glioblastoma, IDH1 kev hloov pauv qhov piv tuaj yeem ncav cuag li 70%.

Thaum lub Yim Hli xyoo no, Ivosidenib tau pom zoo rau ib qho kev qhia tshiab hauv Tebchaws Meskas rau kev siv rau yav dhau los kho cov neeg laus cov neeg mob uas muaj mob qog noj ntshav hauv zos lossis metastatic cholangiocarcinoma kuaj pom los ntawm FDA-pom zoo nrhiav txoj hauv kev. Nws kuj yog tib yam khoom pom zoo ntawm nws hom. Raws li kev suav ntawm" 2018 Tuam Tshoj Cancer Report", muaj txog 40,000 tus neeg mob cholangiocarcinoma hauv Suav teb txhua xyoo, thiab txog li 20% ntawm cov neeg mob muaj kev hloov pauv IDH1.

Nws tuaj yeem pom tau tias nrog kev nthuav dav ntawm cov lus qhia tshiab rau Ivosidenib thiab kev nthuav dav ntxiv ntawm cov neeg muaj, cov tshuaj kuj tseem yuav tawg mus rau hauv kev lag luam ntau dua.