EU pom zoo Opdivo + Yervoy txoj haujlwm tiv thaiv kab mob thib ob

Bristol-Myers Squibb (BMS) tsis ntev los no tshaj tawm tias European Commission (EC) tau pom zoo tiv thaiv PD-1 txoj kev kho Opdivo (nivolumab) ua ke nrog tiv thaiv CTLA-4 txoj kev kho Yervoy (ipilimumab) rau kev kho mob ntawm cov neeg mob uas yav tas los tau txais tshuaj fluoropyrimidine-based ua ke tshuaj kho cov neeg laus uas muaj kev txhim kho, kho tsis zoo (dMMR) lossis siab microsatellite instability (MSI-H) mob qog noj ntshav qog nqaij hlav qog noj ntshav (mCRC).

Nws tsim nyog hais tias Opdivo + Yervoy yog thawj qhov tshuaj tiv thaiv kab mob thib ob tau pom zoo los ntawm European Union rau cov qog nqaij hlav qog noj ntshav hauv plab. Txog tam sim no, txoj haujlwm tau pom zoo hauv European Union los kho 5 hom sib txawv ntawm kev mob qog noj ntshav: mesothelioma, tsis yog mob qog noj ntshav ntawm lub ntsws me, melanoma, qog nqaij hlav hauv lub raum, thiab mob qog noj ntshav.

Thaum Lub Xya Hli 2018, Opdivo + Yervoy tau pom zoo hauv Tebchaws Meskas rau kev kho kab mob kev loj hlob, dMMR lossis MSI-H metastatic disease tom qab kho nrog fluoropyrimidine,oxaliplatin tshuaj, irinotecanMob qog noj ntshav (mCRC) cov neeg laus thiab cov menyuam yaus hnub nyoog 12 xyoos thiab laus dua. Thaum lub Cuaj Hli 2020, Opdivo + Yervoy tau pom zoo hauv Nyij Pooj rau kev kho cov neeg mob uas tsis tuaj yeem kho tau, qib siab lossis rov tshwm sim dua MSI-H mob qog noj ntshav uas tau nce mus tom qab siv tshuaj tua kab mob qog noj ntshav.

Kev pom zoo los ntawm EU yog ua raws cov txiaj ntsig ntawm Opdivo + Yervoy sib koom ua ke hauv ntau lub chaw, qhib-daim ntawv qhia Phase 2 CheckMate-142 txoj kev tshawb fawb. Txoj kev tshawb no tau ua los ntawm Bristol-Myers Squibb. Cov neeg mob uas tau cuv npe yog dMMR lossis MSI-H siab dua lossis rov ua dua CRC cov neeg mob uas tau nce qib thaum lossis tom qab siv tshuaj kho mob (suav nrog fluoropyrimidine), lossis tsis ua siab ntev rau cov tshuaj kho mob no.

Cov txiaj ntsig ntawm kev taug qab yam tsawg kawg ntawm 46.9 lub hlis pom tias hauv txoj kev tshawb fawb no, lub hom phiaj cov lus teb (ORR) ntawm Opdivo + Yervoy kev tiv thaiv kab mob sib kis yog 64.7% (95% CI: 55.4-73.2), ua tiav cov lus teb (CR) yog 12.6%, thiab qhov nruab nrab Lub sijhawm ntawm kev zam txim (DOR) tsis tau mus txog (ntau: 1.4 hli, 58.0 lub hlis lossis ntau dua). Hauv txoj kev tshawb fawb, kev nyab xeeb ntawm Opdivo + Yervoy kev tiv thaiv kev tiv thaiv kab mob zoo ib yam nrog cov txiaj ntsig tau tshaj tawm hauv cov kev tshawb fawb yav dhau los, thiab tsis muaj teeb meem kev nyab xeeb tshiab.

Ian M. Waxman, MD, lub taub hau ntawm txoj hnyuv loj hlob ntawm Bristol-Myers Squibb, hais tias:" Metastatic mob qog noj ntshav qog noj ntshav yog mob hnyav nrog kev ua haujlwm tsis zoo. Ntxiv nrog rau kev siv tshuaj kho tus qauv, cov neeg mob xav tau kev kho mob ntxiv sai. Nrog rau qhov kev pom zoo no, EU mob qog noj ntshav qog noj ntshav nrog metastatic kho tsis zoo (dMMR) lossis siab microsatellite tsis ruaj khov (MSI-H) biomarkers yuav tam sim no tau txais thawj qhov kev kho mob thib ob, thiab peb tos ntsoov rau qhov kev sib xyaw ua ke no coj cov neeg mob tsim nyog."

Cancer Colorectal (CRC) yog mob qog noj ntshav uas tshwm sim hauv cov nyuv lossis qhov quav, uas yog ib feem ntawm tib neeg txoj hnyuv lossis lub plab zom mov. Thoob plaws ntiaj teb, CRC yog qhov thib peb feem ntau kuaj mob qog noj ntshav. Nws tau kwv yees tias yuav muaj kwv yees li 1.931 lab tus neeg mob tshiab hauv xyoo 2020, uas yog qhov thib ob ua rau mob qog noj ntshav muaj feem tuag rau txiv neej thiab poj niam. Kev kho tsis zoo tsis sib xws (dMMR) hais txog qhov poob lossis tsis ua haujlwm ntawm cov protein uas kho qhov tsis sib xws hauv DNA rov ua dua, ua rau muaj cov qog microsatellite tsis ruaj khov (MSI-H). Kwv yees li 5% ntawm cov neeg mob metastatic CRC muaj dMMR lossis MSI-H qog. Cov neeg mob metastatic CRC nrog cov biomarkers no tsis zoo li yuav tau txais txiaj ntsig los ntawm kev siv tshuaj kho mob thiab feem ntau muaj qhov ua tsis zoo.

Opdivo + Yervoy (OY ua ke) yog thawj zaug thiab tsuas yog siv tshuaj tiv thaiv kab mob thib ob kom tau txais kev pom zoo raws cai. Opdivo + Yervoy yog qhov sib xyaw ua ke ntawm 2 qhov chaw tiv thaiv kab mob tiv thaiv kab mob, nrog lub peev xwm ua haujlwm sib koom ua ke. Nws lub hom phiaj 2 qhov chaw kuaj xyuas sib txawv (PD-1 thiab CTLA-4) thiab ua hauv txoj hauv kev ntxiv los pab lub cev rhuav tshem cov qog. ntawm tes. Yervoy tuaj yeem pab qhib thiab nthuav tawm T cells, thaum Opdivo tuaj yeem pab T cells uas twb muaj lawm pom cov qog. Ib qho ntxiv, qee cov T cells txhawb los ntawm Yervoy kuj dhau los ua cim xeeb T cells, uas tuaj yeem ua rau muaj kev tiv thaiv kab mob mus sij hawm ntev.

Txog tam sim no, Opdivo + Yervoy kev kho mob ua ke tau pom zoo rau 7 qhov kev qhia qhia rau 6 hom mob qog noj ntshav (melanoma, mob qog noj ntshav ntawm lub raum, mob qog noj ntshav, mob qog nqaij hlav hauv lub cev, mob qog noj ntshav tsis mob qog noj ntshav, mob qog noj ntshav tsis zoo) .

Ib qho ntxiv, Opdivo + Yervoy kev kho ua ke tau qhia pom kev txhim kho tseem ceeb hauv kev muaj sia nyob tag nrho (OS) hauv 6 theem 3 kev sim tshuaj kho mob: tsis yog mob qog noj ntshav ntawm lub ntsws me me (CheckMate-227, CheckMate-9LA), metastatic melanoma (CheckMate) -067), Cov qog nqaij hlav qog ntshav hauv qib siab (CheckMate-214), mob qog noj ntshav mesothelioma (CheckMate-743), esophageal squamous cell carcinoma (CheckMate-648).