Hengrui Pharmaceutical tau tshaj tawm tsab ntawv ceeb toom rau Lub Kaum Hli 23, hais tias: Tsis ntev los no, cov neeg mob rov qab los lossis metastatic tsis yog mob qog noj ntshav ntawm tes (NSCLC) nrog PD-L1 cov qog hlwb zoo (cov qog nqaij hlav (TPS) ntau dua lossis sib npaug li 1 feem pua) thiab tsis muaj EGFR / ALK gene abnormalities kho los ntawm carrelizumab ua ke nrog kev cai lij choj mitinib, ib qho tshuaj tshiab ntawm Hengri Pharmaceutical, tau suav nrog hauv cov npe ntawm cov tshuaj kho mob ntau yam luam tawm los ntawm Lub Chaw Saib Xyuas Tshuaj ntawm National Medical Products Administration.
Raws li GLOBOCAN 2020 tsab ntawv ceeb toom, qhov tshwm sim ntawm mob ntsws cancer yog qhov thib ob ntawm tag nrho cov qog nqaij hlav, tab sis cov neeg tuag yog thawj, uas ua rau tib neeg kev noj qab haus huv hnyav [1]. NSCLC suav txog li ntawm 85 feem pua ntawm tag nrho cov hom mob ntsws cancer [2]. Vim tias tsis muaj cov tsos mob tshwm sim ntxov, feem ntau NSCLC tau kuaj pom tias mob qog noj ntshav siab metastatic, thiab tag nrho cov kev mob tshwm sim tsis zoo. Hauv 10 xyoo dhau los, kev kho mob ntawm NSCLC tau maj mam hloov los ntawm kev kho mob mus rau kev kho tus kheej raws li tus neeg tsav tsheb hloov pauv. Cov neeg uas muaj kev hloov pauv ntawm tus neeg tsav tsheb tuaj yeem tau txais txiaj ntsig zoo los ntawm kev kho mob ntau dua li kev siv tshuaj khomob. Ntxiv mus, lub hom phiaj tiv thaiv kab mob tiv thaiv kab mob xws li PD-1 / PD-L1 kuj tau ua tau zoo heev hauv kev kho mob ntawm cov neeg mob caj ces tsis zoo, ua kom muaj sia nyob ntev ntawm NSCLC. Txawm li cas los xij, tam sim no, cov txiaj ntsig kev kho mob ntawm thawj kab monotherapy rau hauv zos qib siab lossis metastatic NSCLC nrog PD-L1 TPS Ntau dua lossis sib npaug rau 1 feem pua EGFR kev hloov pauv tsis zoo thiab ALK tsis zoo yog tseem txwv [3]. Yog li ntawd, raws li kev ua tau zoo ntawm kev tiv thaiv kab mob tam sim no, yuav ua li cas txhawm rau txhim kho kev ua tau zoo ntawm cov tshuaj tiv thaiv kab mob, nthuav cov pej xeem tau txais txiaj ntsig los ntawm kev siv tshuaj tiv thaiv kab mob, thiab paub txog lub zeem muag ntawm kev kho mob tsis pub dawb rau cov neeg tsav tsheb gene-negative NSCLC yog qhov tseem ceeb tsis tau txais kev kho mob.
Carrelizumab rau kev txhaj tshuaj yog humanized PD-1 monoclonal antibody ntawm nws tus kheej tsim los ntawm Hengrui Pharmaceutical thiab nrog rau cov tswv cuab kev txawj ntse. Nws tuaj yeem khi rau tib neeg PD-1 receptor thiab thaiv PD-1 / PD-L1 txoj hauv kev los kho lub cev tiv thaiv qog noj ntshav, yog li tsim lub hauv paus ntawm kev kho mob qog noj ntshav. Txij li thaum nws pib thaum lub Tsib Hlis 2019, nws tau raug pom zoo rau 8 qhov qhia txog mob qog noj ntshav, mob qog noj ntshav, mob qog noj ntshav, mob qog noj ntshav, mob qog nqaij hlav nasopharyngeal thiab lymphoma, uas 2 yog thawj kab kev kho mob rau NSCLC. Nws yog ib qho ntawm cov khoom siv hauv tsev PD-1 nrog rau tus naj npawb ntawm cov ntawv pom zoo thiab hom qog. Famitinib malate capsule yog ib qho me me molecule multi-target tyrosine kinase inhibitor ntawm nws tus kheej tsim los ntawm Henrui, uas muaj cov haujlwm inhibitory ntawm ntau yam receptor tyrosine kinases thiab belongs rau ntau lub hom phiaj anti-angiogenesis tsom tshuaj.
Tam sim no, Herui Pharmaceutical tab tom ua ib qho randomized, qhib, tswj, multicenter theem III kev soj ntsuam kev sim ntawm carrelizumab ua ke nrog famitinib malate piv rau pembrolizumab ua thawj kab kev kho mob rau rov tshwm sim lossis metastatic uas tsis yog-me me ntawm lub ntsws cancer nrog qhov zoo PD-L1 qhia.