Thaum Lub Peb Hlis 21, 2025, Junshi Biosciences tshaj tawm tias Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws ("NMPA") tau pom zoo rau daim ntawv thov tshuaj tshiab ntxiv ("sNDA") rau cov khoom lag luam ntawm lub tuam txhab, toripalimab, ua ke nrog bevacizumab rau kev kho mob thawj kab ntawm cov neeg mob uas tsis tuaj yeem phais lossis metastatic hepatocellular carcinoma ("HCC").
Daim ntawv pom zoo ntxiv NDA yog raws li cov ntaub ntawv los ntawm kev tshawb fawb HEPATORCH (NCT04723004), uas yog kev tshawb fawb txog ntau lub chaw kho mob thoob ntiaj teb, kev xaiv tsa, qhib daim ntawv lo, kev tswj hwm theem 3. Xibfwb Jia FAN, tus kws tshawb fawb ntawm Suav Academy of Sciences, los ntawm Tsev Kho Mob Zhongshan koom tes nrog Fudan University, tau ua tus kws tshawb fawb tseem ceeb. HEPATORCH tau pib siv hauv 57 lub chaw kho mob hauv Suav teb, Taiwan thiab Singapore, thiab muaj tag nrho 326 tus neeg mob tau sau npe. Kev tshawb fawb no tsom mus rau kev ntsuam xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm toripalimab ua ke nrog bevacizumab rau kev kho mob thawj kab ntawm HCC uas tsis tuaj yeem phais lossis kis mus rau lwm qhov piv rau kev kho mob tus qauv nrog sorafenib.
Thaum lub Cuaj Hlis 2024, cov txiaj ntsig ntawm txoj kev tshawb fawb HEPATORCH tau tshwm sim thawj zaug ntawm 27th National Clinical Oncology Conference thiab 2024 Chinese Society of Clinical Oncology (CSCO) Academic Annual Meeting. Cov txiaj ntsig ntawm txoj kev tshawb fawb qhia tau hais tias cov ntsiab lus tseem ceeb, kev ciaj sia tsis muaj kev nce qib ("PFS," raws li kev tshuaj xyuas radiographic ywj pheej) thiab OS, ob qho tib si tau txais txiaj ntsig zoo.
HEPATORCH tau qhia tias piv rau sorafenib, toripalimab ua ke nrog bevacizumab tuaj yeem ua rau PFS thiab OS ntawm cov neeg mob ntev dua, nrog rau PFS nruab nrab ntawm 5.8 lub hlis vs. 4.0 lub hlis, txo qhov kev pheej hmoo ntawm kev mob hnyav lossis kev tuag los ntawm 31% (qhov piv txwv txaus ntshai [HR] = 0.69, 95% CI: 0.525-0.913; P = 0.0086), nrog rau OS nruab nrab ntawm 20.0 lub hlis vs. 14.5 lub hlis, thiab txo qhov kev pheej hmoo ntawm kev tuag los ntawm 24% (HR = 0.76, 95% CI: 0.579-0.987; P = 0.0394). Tus nqi teb hom phiaj ("ORR") ntawm pawg toripalimab thiab bevacizumab siab dua li ntawm pawg sorafenib. ORR ntawm ob pawg yog 25.3% thiab 6.1%, raws li. Tsis tas li ntawd xwb, kev kho mob ua ke muaj cov ntaub ntawv kev nyab xeeb zoo rau cov neeg mob uas muaj HCC theem siab heev. Qhov tshuaj lom neeg sib xws nrog cov tshuaj lom neeg paub ntawm kev kho mob ib leeg, thiab tsis muaj cov cim qhia kev nyab xeeb tshiab tau pom.
Txog Toripalimab
Toripalimab yog ib qho antibody monoclonal antibody uas tsim los rau nws lub peev xwm los thaiv kev sib cuam tshuam ntawm PD-1 nrog nws cov ligands, PD-L1 thiab PD-L2, thiab los ua kom PD-1 receptor internalization (endocytosis function). Kev thaiv kev sib cuam tshuam ntawm PD-1 nrog PD-L1 thiab PD-L2 txhawb nqa lub cev tiv thaiv kab mob lub peev xwm los tawm tsam thiab tua cov hlwb qog.
Muaj ntau tshaj plaub caug txoj kev tshawb fawb txog kev siv toripalimab uas lub tuam txhab txhawb nqa tau ua thoob ntiaj teb los ntawm Junshi Biosciences, suav nrog hauv Suav teb, Tebchaws Meskas, Tebchaws Europe thiab Southeast Asia. Cov kev sim tshuaj tseem ceeb uas tseem tab tom ua lossis ua tiav uas ntsuas kev nyab xeeb thiab kev ua tau zoo ntawm toripalimab npog ntau hom qog nqaij hlav, suav nrog mob qog nqaij hlav ntawm lub ntsws, nasopharynx, esophagus, plab, zais zis, mis, siab, raum, thiab tawv nqaij.
Hauv Suav teb, toripalimab yog thawj lub tshuaj anti-PD-1 monoclonal antibody uas tau pom zoo rau kev lag luam (pom zoo hauv Suav teb ua TUOYI®). Tam sim no, muaj kaum ib qho kev qhia pom zoo rau toripalimab hauv Suav teb:
melanoma uas tsis tuaj yeem phais tau lossis kis mus rau lwm qhov tom qab tsis ua tiav kev kho mob ib txwm muaj;
mob qog nqaij hlav nasopharyngeal carcinoma (NPC) uas rov tshwm sim lossis kis mus rau lwm qhov tom qab tsis ua haujlwm tsawg kawg yog ob txoj kev kho mob thoob plaws lub cev yav dhau los;
mob qog nqaij hlav urothelial uas tau kis mus rau lwm qhov chaw lossis kis mus rau lwm qhov chaw uas tsis tau kho mob chemotherapy uas muaj platinum lossis tau nce qib hauv 12 lub hlis ntawm kev kho mob chemotherapy uas muaj platinum lossis adjuvant;
ua ke nrog cisplatin thiab gemcitabine ua thawj kab kev kho mob rau cov neeg mob uas muaj NPC rov tshwm sim hauv zos lossis metastatic;
ua ke nrog paclitaxel thiab cisplatin hauv kev kho mob thawj kab ntawm cov neeg mob uas tsis tuaj yeem phais tau qhov mob siab heev / rov tshwm sim lossis deb ntawm esophageal squamous cell carcinoma (ESCC);
ua ke nrog pemetrexed thiab platinum ua thawj kab kev kho mob hauv EGFR mutation-negative thiab ALK mutation-negative, tsis tuaj yeem phais tau, mob qog nqaij hlav hauv zos lossis metastatic non-squamous non-small cell lung cancer (NSCLC);
ua ke nrog chemotherapy ua kev kho mob perioperative thiab tom qab ntawd nrog monotherapy ua adjuvant therapy rau kev kho mob ntawm cov neeg laus nrog resectable theem IIIA-IIIB NSCLC;
ua ke nrog axitinib rau kev kho mob thawj kab ntawm cov neeg mob uas muaj kev pheej hmoo nruab nrab mus rau siab uas tsis tuaj yeem phais lossis metastatic renal cell carcinoma (RCC);
ua ke nrog etoposide ntxiv rau platinum rau kev kho mob thawj kab ntawm mob qog nqaij hlav me me theem siab (ES-SCLC);
ua ke nrog paclitaxel rau kev txhaj tshuaj (albumin-bound) rau thawj kab kev kho mob ntawm cov mob qog noj ntshav mis triple-negative uas rov tshwm sim lossis kis mus rau lwm qhov (TNBC);
ua ke nrog bevacizumab rau kev kho mob thawj kab ntawm cov neeg mob uas tsis tuaj yeem phais lossis metastatic hepatocellular carcinoma (HCC).
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: Lub Peb Hlis-27-2025