Ngomhla wama-21 kuMatshi 2025, iJunshi Biosciences yabhengeza ukuba iNational Medical Products Administration (“NMPA”) ivumile isicelo esitsha esongezelelweyo samayeza (“sNDA”) kwimveliso yenkampani, i-toripalimab, kunye ne-bevacizumab kunyango lokuqala lwezigulane ezingenakunyangwa okanye ezinesifo se-hepatocellular carcinoma (“HCC”).
Imvume eyongezelelweyo ye-NDA isekelwe kwidatha evela kuphando lwe-HEPATORCH (NCT04723004), oluluphando lwezonyango lwesigaba sesi-3 olunamaziko amaninzi, olucwangcisiweyo, oluvulelekileyo, nolulawulwa ngokusebenzayo. UNjingalwazi uJia FAN, ingcali yezemfundo ye-Chinese Academy of Sciences, evela kwiSibhedlele saseZhongshan esidityaniswe neYunivesithi yaseFudan, wayesebenza njengomphandi oyintloko. I-HEPATORCH yaqaliswa kumaziko ezonyango angama-57 kwilizwekazi laseTshayina, eTaiwan naseSingapore yaseTshayina, kwaye izigulane ezingama-326 zizonke zabhaliswa. Olu phononongo lujolise ekuvavanyeni ukusebenza kakuhle kunye nokhuseleko lwe-toripalimab kunye ne-bevacizumab kunyango lokuqala lwe-HCC engenakucocwa okanye enokusasazeka xa kuthelekiswa nonyango oluqhelekileyo lwe-sorafenib.
NgoSeptemba 2024, iziphumo zophando lwe-HEPATORCH zaqala ukusebenza kwiNgqungquthela yeSizwe ye-27 ye-Clinical Oncology kunye neNtlanganiso yoNyaka ye-2024 ye-Chinese Society of Clinical Oncology (CSCO). Iziphumo zophando zibonise ukuba iingongoma eziphambili, ukusinda okungenankqubela phambili (“PFS,” ngokusekelwe kuphononongo oluzimeleyo lwe-radiographic) kunye ne-OS, zombini zifumene iziphumo ezilungileyo.
I-HEPATORCH ibonise ukuba xa ithelekiswa ne-sorafenib, i-toripalimab xa idibene ne-bevacizumab inokwandisa kakhulu i-PFS kunye ne-OS yezigulane, kunye ne-PFS ephakathi yeenyanga ezi-5.8 xa kuthelekiswa neenyanga ezi-4.0, kunciphisa umngcipheko wokuqhubela phambili kwesifo okanye ukufa nge-31% (umlinganiselo wobungozi [HR]=0.69, 95% CI: 0.525-0.913; P=0.0086), kunye ne-OS ephakathi yeenyanga ezingama-20.0 xa kuthelekiswa neenyanga ezili-14.5, kwaye kunciphisa umngcipheko wokufa nge-24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). Izinga lokuphendula elichanekileyo (“ORR”) leqela le-toripalimab kunye ne-bevacizumab laliphezulu kakhulu kunelo leqela le-sorafenib. I-ORR yamaqela amabini yayiyi-25.3% kunye ne-6.1%, ngokwahlukeneyo. Ngaphezu koko, unyango oludibeneyo luneprofayili entle yokhuseleko kwizigulane ezine-HCC ephucukileyo. Uluhlu lwetyhefu luhambelana noluhlu lwetyhefu olwaziwayo lwe-monotherapy eqhelekileyo, kwaye akukho sibonakaliso sitsha sokhuseleko esichongiweyo.
Malunga neToripalimab
I-Toripalimab yi-antibody ye-monoclonal antibody elwa ne-PD-1 eyenzelwe ukukwazi kwayo ukuthintela ukusebenzisana kwe-PD-1 kunye ne-ligands zayo, i-PD-L1 kunye ne-PD-L2, kunye nokukhuthaza i-PD-1 receptor internalization (umsebenzi we-endocytosis). Ukuthintela ukusebenzisana kwe-PD-1 kunye ne-PD-L1 kunye ne-PD-L2 kukhuthaza amandla omzimba okuhlasela nokubulala iiseli zethumba.
Izifundo zeklinikhi ezingaphezu kwamashumi amane ezixhaswe yinkampani ze-toripalimab ezigubungela iimpawu ezingaphezu kweshumi elinesihlanu zenziwe kwihlabathi liphela yiJunshi Biosciences, kuquka eTshayina, eMelika, eYurophu nakuMzantsi-mpuma we-Asia. Uvavanyo lweklinikhi oluqhubekayo okanye olugqityiweyo oluvavanya ukhuseleko kunye nokusebenza kakuhle kwe-toripalimab lugubungela uluhlu olubanzi lwee-tumor, kubandakanya umhlaza wemiphunga, i-nasopharynx, i-esophagus, isisu, isinyi, ibele, isibindi, izintso kunye nolusu.
Kwilizwekazi laseTshayina, i-toripalimab yayiyeyona antibody yokuqala yasekhaya yokulwa ne-PD-1 monoclonal eyamkelweyo ukuba ithengiswe (yamkelwe eTshayina njenge-TUOYI®). Okwangoku, kukho imiqondiso elishumi elinanye evunyiweyo ye-toripalimab kwilizwekazi laseTshayina:
i-melanoma engasuswayo okanye esasazekayo emva kokungaphumeleli konyango oluqhelekileyo lwenkqubo;
i-recurrent okanye i-metastatic nasopharyngeal carcinoma (NPC) emva kokungaphumeleli konyango lwenkqubo yangaphambili oluphindwe kabini;
i-urothelial carcinoma eqhubele phambili okanye esasazekileyo kwindawo ethile engakhange iphumelele kwi-chemotherapy equlethe i-platinum okanye eqhubekele phambili kwiinyanga ezili-12 ze-neoadjuvant okanye i-adjuvant platinum-containing chemotherapy;
kunye ne-cisplatin kunye ne-gemcitabine njengonyango lokuqala kwizigulane ezine-NPC ephindaphindayo okanye esasazekayo;
kunye ne-paclitaxel kunye ne-cisplatin kunyango lokuqala lwezigulane ezine-carcinoma ye-squamous cell ekhula ngokukhawuleza/ephindaphindayo okanye ekude ekhula ngokukhawuleza (ESCC);
ngokudibeneyo ne-pemetrexed kunye ne-platinum njengonyango lokuqala kwi-EGFR mutation-negative kunye ne-ALK mutation-negative, engasuswayo, i-local advanced okanye i-metastatic non-squamous non-small cell lung cancer (NSCLC);
kunye ne-chemotherapy njengonyango oluqhutywa emva kotyando kwaye emva koko kunye ne-monotherapy njengonyango oluncedisayo kunyango lwezigulane zabantu abadala abane-IIIA-IIIB NSCLC enokucocwa;
kunye ne-axitinib kunyango lokuqala lwezigulane ezine-metastatic renal cell carcinoma (RCC) enomngcipheko ophakathi ukuya phezulu okanye enomhlaza weeseli zezintso osasazekayo (i-RCC);
kunye ne-etoposide kunye neplatinum kunyango lokuqala lomhlaza wemiphunga weeseli ezincinci zesigaba esibanzi (ES-SCLC);
kunye ne-paclitaxel yokujova (ebotshelelwe kwi-albumin) kunyango lokuqala lomhlaza webele ophindaphindayo okanye osasazekayo (TNBC);
kunye ne-bevacizumab kunyango lokuqala lwezigulane ezingakwaziyo ukucocwa okanye ezine-metastatic hepatocellular carcinoma (HCC).
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Ixesha leposi: Matshi-27-2025