Thaum Lub Plaub Hlis 23, Akeso's penpulimab tau txais kev pom zoo los ntawm Lub Chaw Saib Xyuas Khoom Noj thiab Tshuaj nrog cisplatin lossis carboplatin thiab gemcitabine rau kev kho mob thawj kab ntawm cov neeg laus uas muaj mob qog nqaij hlav rov tshwm sim lossis kis mus rau lwm qhov (NPC). FDA kuj tau pom zoo penpulimab-kcqx ua ib tus neeg sawv cev rau cov neeg laus uas muaj mob qog nqaij hlav metastatic non-keratinizing NPC nrog kev nce qib ntawm tus kab mob rau lossis tom qab platinum-based chemotherapy thiab tsawg kawg yog ib kab kev kho mob ua ntej.
Kev siv tshuaj penpulimab-kcqx nrog cisplatin lossis carboplatin thiab gemcitabine tau raug soj ntsuam hauv Kev Kawm AK105-304 (NCT04974398), kev sim tshuaj randomized, ob chav dig muag, ntau lub chaw hauv 291 tus neeg mob uas muaj NPC rov tshwm sim lossis metastatic uas tsis tau txais kev kho mob chemotherapy yav dhau los rau tus kab mob rov tshwm sim lossis metastatic. Cov neeg mob tau raug xaiv (1:1) kom tau txais penpulimab-kcqx nrog cisplatin lossis carboplatin thiab gemcitabine, ua raws li penpulimab-kcqx, lossis placebo nrog cisplatin lossis carboplatin thiab gemcitabine, ua raws li placebo. Cov txheej txheem kho mob chemotherapy tau piav qhia hauv cov ntaub ntawv sau tshuaj tag nrho.
Qhov kev ntsuas qhov ua tau zoo tshaj plaws yog kev ciaj sia tsis muaj kev nce qib (PFS), raws li tau soj ntsuam los ntawm Pawg Neeg Saib Xyuas Kev Ywj Pheej Blinded raws li RECIST v1.1. Tag nrho kev ciaj sia (OS) yog qhov tseem ceeb thib ob. PFS nruab nrab yog 9.6 lub hlis (95% CI: 7.1, 12.5) hauv pawg penpulimab-kcqx thiab 7.0 lub hlis (95% CI: 6.9, 7.3) hauv pawg placebo (qhov piv txwv txaus ntshai [HR] 0.45 [95% CI: 0.33, 0.62], ob sab p-tus nqi <0.0001), nrog 31% thiab 11% ntawm cov neeg mob muaj sia nyob thiab tsis muaj kev nce qib tom qab 12 lub hlis ntawm kev saib xyuas hauv pawg penpulimab-kcqx thiab placebo, raws li. Txawm hais tias cov txiaj ntsig OS tseem tsis tau paub tab, nrog 70% ntawm cov neeg tuag uas tau teev tseg rau qhov kev tshuaj xyuas zaum kawg tau tshaj tawm, tsis muaj qhov sib txawv tsis zoo tau pom.
Kev siv tshuaj penpulimab-kcqx ib leeg tau raug soj ntsuam hauv Kev Kawm AK105-202 (NCT03866967), uas yog kev sim tshuaj qhib, ntau lub chaw, ib sab caj npab uas tau ua hauv ib lub tebchaws. Kev sim tshuaj no suav nrog tag nrho 125 tus neeg mob uas muaj NPC uas tsis tuaj yeem phais lossis kis mus rau lwm qhov uas tsis yog keratinizing uas muaj kev mob hnyav tom qab kev kho mob platinum thiab tsawg kawg yog ib txoj kev kho mob ntxiv. Cov neeg mob tau txais penpulimab-kcqx kom txog thaum mob hnyav zuj zus lossis muaj kev lom tsis zoo, rau siab tshaj plaws 24 lub hlis.
Cov kev ntsuas tseem ceeb ntawm qhov ua tau zoo yog qhov teb sai (ORR) thiab lub sijhawm teb (DOR) raws li RECIST v1.1 raws li tau soj ntsuam los ntawm Pawg Neeg Saib Xyuas Kev Tshawb Fawb Txog Kev Siv Hluav Taws Xob. Thaum hnub kawg ntawm cov ntaub ntawv (Cuaj Hlis 28, 2022), 1 tus neeg mob tau teb tiav thiab 34 tus neeg mob tau teb ib nrab. ORR yog 28.0% (95% CI 20.3–36.7%). Cov lus teb tau ruaj khov, nrog rau 66.8% tseem teb tau thaum 9 lub hlis. Peb caug peb tus neeg mob (26.4%) tseem tau kho mob. Qhov nruab nrab PFS thiab OS yog 3.6 lub hlis (95% CI = 1.9–7.3 lub hlis) thiab 22.8 lub hlis (95% CI = 17.1 lub hlis tsis tau txog), raws li. Kaum (7.6%) cov neeg mob tau ntsib qib 3 lossis siab dua irAEs. Penpulimab muaj cov haujlwm tiv thaiv qog nqaij hlav zoo thiab cov tshuaj lom uas siv tau rau cov neeg mob NPC metastatic uas tau kho mob hnyav, txhawb nqa kev txhim kho ntxiv rau kev kho mob kab thib peb ntawm NPC metastatic.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Plaub Hlis-25-2025