Thaum Lub Peb Hlis 16, 2025, Akeso tshaj tawm tias nws cov tshuaj antibody anti-PD-1 monoclonal tshiab, penpulimab, tau txais kev pom zoo los ntawm National Medical Products Administration (NMPA) rau kev kho mob thawj kab ntawm cov mob qog nqaij hlav nasopharyngeal rov tshwm sim lossis metastatic (NPC) ua ke nrog kev kho mob chemotherapy.
Penpulimab (PD-1 Monoclonal Antibody) tam sim no yog tib qho PD-1 monoclonal antibody uas siv IgG1 subtype nrog hloov kho Fc-nulldomain, uas tuaj yeem txhim kho kev ua haujlwm ntawm kev tiv thaiv kab mob thiab txo cov kev tsis zoo ntawm kev tiv thaiv kab mob. Nws yog siv rau hauv kev kho mob ntawm cov kab mob loj xws li mob qog noj ntshav ntsws, lymphoma, mob qog noj ntshav nasopharyngeal, mob qog noj ntshav siab, thiab mob qog noj ntshav hauv plab, nrog kev nyab xeeb thiab kev ua haujlwm zoo dua raws li tau pom hauv kev tshawb fawb hauv tsev kho mob.
Qhov no yog qhov kev qhia thib plaub uas tau pom zoo rau penpulimab. Ntxiv rau ob qho kev qhia NPC, penpulimab kuj tau pom zoo rau kev kho mob thawj kab ntawm mob qog nqaij hlav squamous non-small cell lung cancer (NSCLC) uas tau kis mus rau lwm qhov chaw thaum ua ke nrog kev kho mob chemotherapy, nrog rau kev kho mob monotherapy rau cov neeg mob uas rov qab mob lossis tsis kho tau classical Hodgkin lymphoma (cHL) uas tau txais tsawg kawg yog ob kab ntawm kev kho mob systemic chemotherapy yav dhau los. Ntxiv mus, Daim Ntawv Thov Tshuaj Tshiab (sNDA) rau penpulimab ua ke nrog anlotinib rau kev kho mob thawj kab ntawm mob qog nqaij hlav siab (HCC) uas tau kis mus rau lwm qhov tam sim no tab tom raug tshuaj xyuas.
Yav tas los, penpulimab tau pom zoo siv ua kev kho mob thib peb rau NPC theem siab. Nrog rau qhov kev pom zoo tshiab no, penpulimab tam sim no muab kev kho mob dav dav thoob plaws txhua theem ntawm NPC, muab rau cov neeg mob xaiv kev kho mob tiv thaiv kab mob txuas ntxiv mus los ntawm thawj kab mus rau kab thib peb.
Thaum Lub Rau Hli 19, 2024, "Signal Transduction and Targeted Therapy" tau tshaj tawm cov txiaj ntsig ntawm kev tshawb fawb theem II ntawm kev kho mob ntawm cov mob qog nqaij hlav metastatic nasopharyngeal carcinoma uas tau kho ua ntej nrog pembrolizumab.
Qhov kev sim theem ob no tau ua thoob plaws 20 lub chaw saib xyuas theem siab hauv Suav teb uas tau sau npe cov neeg mob laus uas muaj mob qog nqaij hlav metastatic nasopharyngeal carcinoma (NPC) uas tau ua tsis tiav ob lossis ntau kab ntawm kev kho mob chemotherapy yav dhau los. Cov neeg mob tau txais 200-mg penpulimab intravenously txhua 2 lub lis piam (4 lub lis piam ib lub voj voog) kom txog thaum tus kab mob loj hlob lossis tsis muaj kev lom. Lub ntsiab lus tseem ceeb yog qhov kev teb rov qab (ORR) ib RECIST (version 1.1), raws li tau soj ntsuam los ntawm pawg neeg saib xyuas kev tshuaj ntsuam xyuas hluav taws xob ywj pheej. Lub ntsiab lus thib ob suav nrog kev ciaj sia tsis muaj kev loj hlob (PFS) thiab kev ciaj sia tag nrho (OS). Muaj ib puas peb caug tus neeg mob tau sau npe thiab 125 tau ntsuas tau qhov ua tau zoo. Thaum hnub txiav cov ntaub ntawv (Cuaj Hlis 28, 2022), 1 tus neeg mob tau txais kev teb tiav thiab 34 tus neeg mob tau txais kev teb ib nrab. ORR yog 28.0% (95% CI 20.3–36.7%). Cov lus teb tau ruaj khov, nrog 66.8% tseem teb thaum 9 lub hlis. Peb caug peb tus neeg mob (26.4%) tseem tau txais kev kho mob. Qhov nruab nrab ntawm 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 tus neeg mob (7.6%) tau muaj irAEs qib 3 lossis siab dua. Penpulimab muaj cov haujlwm tiv thaiv qog thiab cov tshuaj lom uas txaus siab rau cov neeg mob NPC metastatic uas tau kho ua ntej lawm, txhawb nqa kev txhim kho kev kho mob ntxiv ua 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