Nov 2021: Pembrolizumab (Keytruda, Merck) ngokuhambisana nokwelashwa ngamakhemikhali, ene-bevacizumab noma ngaphandle kwayo, kugunyazwe i-Food and Drug Administration ezigulini ezinomdlavuza womlomo wesibeletho ophikelelayo, ophindaphindayo, noma onesimila esiveza i-PD-L1 (CPS 1), njengoba kunqunywe ukuhlolwa okugunyazwe yi-FDA.
I-Pembrolizumab iphinde yanikezwa ukugunyazwa okujwayelekile njengokwelashwa okukodwa yi-FDA ezigulini ezinomdlavuza womlomo wesibeletho ophindelelayo noma ometastatic eziqhubeka nokukhula kwesifo ngesikhathi sokwelashwa ngamakhemikhali noma ngemva kwalokho futhi izimila zazo eziveza i-PD-L1 (CPS 1), njengoba kusungulwe ukuhlolwa okugunyazwe yi-FDA. I-FDA inikeze ukugunyazwa okusheshayo kwalesi sibonakaliso ngoJuni 2018, kanye nokuhlolwa okuhambisanayo, i-PD-L1 IHC 22C3 pharmDx (Dako North America Inc.).
I-Pembrolizumab ene-paclitaxel ne-cisplatin noma i-paclitaxel ne-carboplatin, noma ngaphandle bevacizumab, yafundwa ku-KEYNOTE-826 (NCT03635567), isivivinyo esilawulwa yi-placebo esinezindawo eziningi, esingahleliwe, esingaboni kabili, esilawulwa yi-placebo. Ukuhlolwa kwakuhilela iziguli ezingama-617 ezazingazange zelashwe nge-chemotherapy futhi ezinezifo ezingelapheki, eziphindaphindayo, noma zomugqa wokuqala we-metastatic. umdlavuza wesibeletho. Iziguli zabhaliswa kungakhathaliseki ukuthi zinenkulumo ye-PD-L1 noma. I-Pembrolizumab 200 mg ene-chemotherapy ene-bevacizumab noma i-placebo noma ngaphandle kwe-chemotherapy ene-bevacizumab noma ngaphandle kwayo yabelwa ngokungahleliwe (1:1) kwelinye lamaqembu amabili okwelapha. I-Pembrolizumab yanikezwa kuze kube yilapho ukukhula kwesifo, ubuthi obungabekezeleleki, noma sekudlule izinyanga ezingama-24 kusukela ekuqaleni kocwaningo.
Ukusinda sekukonke (i-OS) kanye ne-progression-free survival (PFS) kwakuyizinyathelo ezibalulekile zomphumela, ezahlolwa umphenyi esebenzisa i-RECIST v1.1, eyalungiswa ukuze ilandele ubuningi bezilonda eziqondiwe eziyi-10 kanye nezilonda eziqondiwe ezingu-5. ngesitho ngasinye. I-ORR nobude bokusabela nakho kusetshenziswe njengezinyathelo ezengeziwe zomphumela (DoR). I-OS emaphakathi engalweni ye-pembrolizumab ayifinyelelwanga (amaphesenti angama-95 CI: 19.8, NR) futhi yaba yizinyanga eziyi-16.3 (amaphesenti angama-95 CI: 14.5, 19.4) engalweni ye-placebo (HR 0.64; 95 amaphesenti CI: 0.50, 0.81; 1- i-p-value eseceleni = 0.0001) ezigulini ezinamathumba aveza i-PD-L1 (CPS 1, N=548). I-PFS emaphakathi engalweni ye-pembrolizumab yayiyizinyanga ezingu-10.4 (amaphesenti angu-95 CI: 9.7, 12.3), kuyilapho ingalo ye-placebo yayiyizinyanga ezingu-8.2 (amaphesenti angu-95 CI: 6.3, 8.5) (HR 0.62; 95 amaphesenti CI: 0.50, 0.77; 1-0.0001; okuseceleni kwe-p-value 68). Ezingalo ze-pembrolizumab kanye ne-placebo, amazinga okuphendula okuhlosiwe ayengamaphesenti angu-95 (amaphesenti angu-62 CI: 74, 50) namaphesenti angu-95 (amaphesenti angu-44 CI: 56, 18.0), ngokulandelana, nama-DoR aphakathi kuka-10.4 kanye nezinyanga ezingu-XNUMX.
I-Pembrolizumab, i-chemotherapy, ne-bevacizumab yayihlotshaniswa ne-peripheral neuropathy, i-alopecia, i-anemia, ukukhathala/i-asthenia, isicanucanu, i-neutropenia, isifo sohudo, umfutho wegazi ophakeme, i-thrombocytopenia, ukuqunjelwa, i-arthralgia, ukuhlanza, ukutheleleka komgudu womchamo, ukwehla kwesifo sohudo, i-lemia Amaphesenti angu-20 eziguli.
I-Pembrolizumab inikezwa ngethamo lama-200 mg njalo emavikini ama-3 noma ama-400 mg njalo emavikini ayi-6 kuze kube yilapho kuvela ukukhula kwesifo noma ubuthi obungamukeleki, obungathatha izinyanga ezingama-24.
