NgoMashi 21, 2025, i-Junshi Biosciences yamemezela ukuthi i-National Medical Products Administration (“NMPA”) ivumile isicelo esisha somuthi esengeziwe (“sNDA”) somkhiqizo wenkampani, i-toripalimab, kanye ne-bevacizumab yokwelashwa kokuqala kweziguli ezinesifo somdlavuza wesibindi esingasuswa noma esisakazekile (“HCC”).
Ukuvunyelwa kwe-NDA okwengeziwe kusekelwe kudatha evela ocwaningweni lwe-HEPATORCH (NCT04723004), oluwucwaningo lwezokwelapha lwesigaba sesi-3 oluhlanganisa izikhungo eziningi, olungahleliwe, oluvulekile, olulawulwa ngokusebenzayo. USolwazi Jia FAN, isazi se-Chinese Academy of Sciences, esivela eZhongshan Hospital exhumene neFudan University, wasebenza njengomphenyi oyinhloko. I-HEPATORCH yethulwa ezikhungweni zezokwelapha ezingu-57 ezwenikazi laseShayina, eTaiwan naseSingapore yaseShayina, futhi kwabhaliswa iziguli ezingu-326. Lolu cwaningo luhlose ukuhlola ukusebenza kahle nokuphepha kwe-toripalimab ngokuhlanganiswa ne-bevacizumab ekwelashweni kokuqala kwe-HCC engasuswa noma esakazeka uma kuqhathaniswa nokwelashwa okujwayelekile nge-sorafenib.
NgoSepthemba 2024, imiphumela yocwaningo lwe-HEPATORCH yaqala ukubonakala eNgqungqutheleni Kazwelonke Ye-Clinical Oncology yama-27 kanye noMhlangano Waminyaka Yonke Wezemfundo We-Chinese Society of Clinical Oncology (CSCO) ka-2024. Imiphumela yocwaningo ibonise ukuthi amaphuzu okugcina ayinhloko, ukusinda okungenakho ukuqhubekela phambili (“PFS,” ngokusekelwe ekubuyekezweni okuzimele kwe-radiographic) kanye ne-OS, kokubili kuthole imiphumela emihle.
I-HEPATORCH ikhombisile ukuthi uma kuqhathaniswa ne-sorafenib, i-toripalimab ehlanganiswe ne-bevacizumab ingandisa kakhulu i-PFS kanye ne-OS yeziguli, nge-PFS ephakathi kwezinyanga ezingu-5.8 uma kuqhathaniswa nezinyanga ezingu-4.0, inciphise ingozi yokuqhubeka kwesifo noma ukufa ngo-31% (isilinganiso sengozi [HR]=0.69, 95% CI: 0.525-0.913; P=0.0086), nge-OS ephakathi yezinyanga ezingu-20.0 uma kuqhathaniswa nezinyanga ezingu-14.5, futhi inciphise ingozi yokufa ngo-24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). Izinga lokuphendula eliqondile (“ORR”) leqembu le-toripalimab kanye ne-bevacizumab laliphezulu kakhulu kuneleqembu le-sorafenib. I-ORR yamaqembu amabili yayingu-25.3% kanye no-6.1%, ngokulandelana. Ngaphezu kwalokho, ukwelashwa okuhlanganisiwe kunephrofayili enhle yokuphepha ezigulini ezine-HCC ethuthukisiwe. Ububanzi bobuthi buhambisana nobubanzi bobuthi obaziwayo be-monotherapy ejwayelekile, futhi akukho signali entsha yokuphepha etholakele.
Mayelana ne-Toripalimab
I-Toripalimab iyi-antibody ye-monoclonal anti-PD-1 eyenzelwe ikhono layo lokuvimba ukusebenzisana kwe-PD-1 nama-ligand ayo, i-PD-L1 kanye ne-PD-L2, kanye nokukhuthaza ukwenziwa kwe-PD-1 receptor internalization (umsebenzi we-endocytosis). Ukuvimba ukusebenzisana kwe-PD-1 ne-PD-L1 kanye ne-PD-L2 kukhuthaza ikhono lesistimu yomzimba lokuhlasela nokubulala amangqamuzana esimila.
Izifundo zezokwelapha ze-toripalimab ezingaphezu kwamashumi amane ezixhaswe yinkampani ezihlanganisa izinkomba ezingaphezu kweshumi nanhlanu zenziwe emhlabeni wonke yi-Junshi Biosciences, okuhlanganisa ne-China, i-United States, i-Europe kanye ne-Southeast Asia. Izivivinyo zezokwelapha ezibalulekile eziqhubekayo noma eziqediwe ezihlola ukuphepha nokusebenza kahle kwe-toripalimab zihlanganisa izinhlobo eziningi zezimila, okuhlanganisa umdlavuza wamaphaphu, i-nasopharynx, i-esophagus, isisu, isinye, ibele, isibindi, izinso kanye nesikhumba.
Ezweni laseShayina, i-toripalimab yayiyi-antibody yokuqala yasekhaya yokulwa ne-PD-1 monoclonal evunyelwe ukumaketha (evunyelwe eShayina njenge-TUOYI®). Njengamanje, kunezinkomba eziyishumi nanye ezivunyelwe ze-toripalimab ezweni laseShayina:
i-melanoma engasuswa noma esakazeka ngemuva kokwehluleka kokwelashwa okujwayelekile kwesistimu;
i-carcinoma ye-nasopharyngeal ephindaphindayo noma esakazeka kalula (i-NPC) ngemva kokwehluleka okungenani kwemigqa emibili yokwelashwa kwesistimu kwangaphambilini;
i-urothelial carcinoma ethuthukisiwe noma esakazeke endaweni ethile ehlulekile ukwelashwa ngamakhemikhali ane-platinum noma eqhubekele phambili zingakapheli izinyanga eziyi-12 zokwelashwa ngamakhemikhali ane-neoadjuvant noma adjuvant platinum ane-chemotherapy;
kuhlanganiswe ne-cisplatin kanye ne-gemcitabine njengokwelashwa kokuqala kweziguli ezine-NPC ephindaphindayo noma esakazekile endaweni;
ngokuhlanganiswa ne-paclitaxel kanye ne-cisplatin ekwelapheni kokuqala kweziguli ezine-carcinoma ye-squamous cell ephindaphindayo noma ehlala kude engasuswanga endaweni ethile (ESCC);
ngokuhlanganiswa ne-pemetrexed kanye ne-platinum njengokwelashwa kokuqala kumdlavuza wamaphaphu we-EGFR ongenayo i-mutation kanye ne-ALK-negative, ongasuleki, othuthukisiwe endaweni noma osakazeke ku-metastatic non-squamous non-small cell lung cancer (NSCLC);
kuhlanganiswe ne-chemotherapy njengokwelashwa okwenziwa ngaphambi kokuhlinzwa kanye nokwelashwa okukodwa njengokwelashwa okusizayo ekwelapheni iziguli ezindala ezinesigaba se-IIIA-IIIB NSCLC esingasuswa;
kuhlanganiswe ne-axitinib yokwelashwa kokuqala kweziguli ezine-renal cell carcinoma (RCC) enobungozi obuphakathi kuya phezulu noma enokusabalala kwe-metastatic renal cell carcinoma;
kuhlanganiswe ne-etoposide kanye ne-platinum yokwelapha umdlavuza wamaphaphu wesigaba esikhulu (i-ES-SCLC);
kuhlanganiswe ne-paclitaxel yokujova (eboshelwe kwi-albhamu) yokwelapha umdlavuza webele ophindaphindayo noma osakazeka kathathu (TNBC);
Kuhlanganiswe ne-bevacizumab ekwelapheni kokuqala kweziguli ezinesifo somdlavuza wesibindi (i-HCC) esingasuswa noma esisakazeke kakhulu.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Mashi-27-2025