Thaum Lub Kaum Hli 10, Merck tshaj tawm tias nws cov PD-1 inhibitor, Keytruda (aborizumab, lub npe lag luam Creida), tau pom zoo los ntawm Tuam Tshoj Lub Xeev Food and Drug Administration (NMPA) rau kev kho mob monotherapy hauv cov neeg mob hepatocellular carcinoma (HCC) uas yav dhau los tau txais sorafenib lossis oxaliplatin-muaj tshuaj khomob. Txog tam sim no, muaj cuaj qhov kev pom zoo rau Keytruda hauv Suav teb.
Keytruda, PD-1 inhibitor tsim los ntawm Merck, thaiv kev cuam tshuam ntawm PD-1 thiab nws cov ligands PD-L1 thiab PD-L2, yog li ua kom T lymphocytes uas tuaj yeem cuam tshuam cov qog hlwb thiab cov hlwb noj qab haus huv, thiab tom qab ntawd txhim kho lub peev xwm ntawm tib neeg lub cev tiv thaiv kab mob txhawm rau txheeb xyuas thiab tshem tawm cov qog nqaij hlav cancer.
Qhov kev pom zoo tshiab qhia txog kev mob qog noj ntshav siab yog raws li cov ntaub ntawv los ntawm theem III kev sim tshuaj ntsuam xyuas, KEYNOTE-394, tsim los ntsuas qhov ua tau zoo ntawm Keytruda ua ke nrog kev txhawb nqa zoo tshaj plaws piv rau cov placebo ua ke nrog kev txhawb nqa zoo tshaj plaws hauv Asian, yav tas los kho cov neeg mob nrog cov kab mob siab hepatocellular carcinoma. Qhov kev tshawb fawb thawj qhov kawg ntawm qhov kev sim yog tag nrho cov ciaj sia taus (OS), thiab cov kev tshawb fawb theem nrab suav nrog kev muaj sia nyob tsis muaj sia nyob (PFS), lub hom phiaj teb tus nqi (ORR), ncua sij hawm tshem tawm, thiab tus nqi tswj kab mob.
Cov txiaj ntsig tau pom tias pab pawg sim txo qhov kev pheej hmoo tuag los ntawm 21 feem pua piv rau pawg placebo. Qhov nruab nrab OS yog 14.6 lub hlis, piv rau 13.0 hli hauv cov placebo pab pawg. Tsis tas li ntawd, kev sib xyaw ua ke yuav txo tau txoj kev pheej hmoo ntawm kev kis kab mob lossis tuag los ntawm 26 feem pua. ORR yog 12.7 feem pua hauv pab pawg sim thiab 1.3 feem pua hauv pawg placebo. Hais txog kev nyab xeeb, kev kho mob ntsig txog cov xwm txheej tsis zoo (TRAE) tshwm sim hauv 66.9 feem pua ntawm cov neeg mob thiab 49.7 feem pua ntawm cov neeg mob hauv pawg placebo, thiab qib 3 - 5 tshwm sim hauv 14.4 feem pua ntawm pab pawg sim thiab 5.9 feem pua ntawm cov placebo pab pawg nrog TRAE.
Thaum lub Cuaj Hlis 2014, Keytruda tau pom zoo thawj zaug hauv Tebchaws Meskas hauv kev kho mob melanoma, dhau los ua thawj FDA pom zoo PD-1 inhibitor, thiab tam sim no nws tau pom zoo rau ntau tshaj 30 qhov qhia hauv Tebchaws Meskas. Thaum Lub Xya Hli 2018, Keytruda tau pom zoo thawj zaug rau kev kho mob melanoma hauv Suav teb. Tsis suav nrog qhov qhia tshiab no, yim qhov qhia tau pom zoo los ntawm Keytruda hauv Suav teb yog:
●: unresectable los yog metastatic melanoma nrog ua tsis tiav thawj kab kev kho mob;
● ua ke nrog pemetrexed thiab platinum chemotherapy yog siv rau thawj kab kev kho mob ntawm metastatic non-squamous non-small-cell ntsws cancer (NSCLC) nrog epidermal growth factor receptor (EGFR) noob mutation-negative thiab anaplastic lymphoma kinase (ALK) - Cov xwm txheej tsis zoo;
Lub ● tau soj ntsuam los ntawm NMPA-pom kev ntsuam xyuas raws li PD-L1 qog feem feem feem (TPS) ntawm 1 feem pua EGFR noob mutation-negative thiab ALK-negative hauv zos advanced lossis metastatic NSCLC thawj kab monotherapy;
Muab carboplatin thiab paclitaxel rau thawj kab kev kho mob ntawm cov neeg mob metastatic squamous NSCLC;
● monotherapy tau siv los ntawm NMPA-pom kev ntsuam xyuas los ntsuas kev kho mob ntawm cov neeg mob qog nqaij hlav qhia PD-L1 [composite positive score (CPS) 10], yav dhau los thawj kab kab mob kev kho tsis ua haujlwm, hauv zos qib siab lossis metastatic esophageal squamous cell carcinoma.
●, ua ke nrog platinum thiab fluorouracil chemotherapeutics, yog siv rau thawj kab kev kho mob ntawm cov neeg mob uas nyob rau hauv lub zos advanced unresectable los yog metastatic esophageal los yog gastroesophageal junction cancer;
● monotherapy tau siv los ntsuas thawj kab kev kho mob ntawm cov neeg mob uas muaj metastatic lossis tsis tuaj yeem rov ua dua lub taub hau thiab NS cell carcinoma nrog cov qog nthuav tawm PD-L1 [CPS 20] los ntawm kev kuaj pom zoo;
Lub ● monotherapy yog siv rau kev kho thawj kab ntawm cov neeg mob uas muaj KRAS, NRAS, thiab BRAF cov noob uas yog txhua hom tsiaj qus, tsis tuaj yeem kho lossis metastatic siab microsatellite instability (MSI-H), lossis kho cov noob tsis zoo (dMMR) cov kab mob hauv lub cev. mob qog noj ntshav.
Dr. Li Zhengqing, Tus Lwm Thawj Coj Loj, Thawj Tswj Hwm ntawm Tuam Tshoj R & D Center, Merck, tau hais tias:
Txoj kev tshawb fawb KEYNOTE-394, uas tau tshaj tawm ntawm lub rooj sib tham thoob ntiaj teb kev kawm ua ntej xyoo no, tam sim no txhawb kom pom zoo rau Keytruda thib ob-kab kev kho mob rau cov kab mob siab hepatocellular hauv Suav teb. Tam sim no, tom qab kev kho mob muaj sia nyob tau txais txiaj ntsig ntawm cov neeg mob nrog HCC qib siab qis, thiab tseem muaj cov kev kho mob loj heev uas yuav tsum tau ua. Kev pom zoo ntawm daim ntawv pov thawj Keytruda tshiab muab ' riam phom' tshiab tiv thaiv hom refractory ntawm hepatocellular carcinoma, thiab tseem muab kev kho mob tshiab rau cov kws kho mob thiab cov neeg mob.
Keytruda lub ntiaj teb kev muag khoom tau mus txog $ 17.2 nphom xyoo tas los, thiab nws tau tsim $ 10.061 nphom hauv cov nyiaj tau los hauv thawj ib nrab ntawm lub xyoo no, nce ze li 30 feem pua ntawm xyoo dhau los.