Maarso 21, 2025, Junshi Biosciences waxay ku dhawaaqday in Maamulka Badeecadaha Caafimaadka Qaranka ("NMPA") uu ansixiyay codsiga daawada cusub ee dheeraadka ah ("sNDA") ee badeecada shirkadda, toripalimab, iyadoo lagu darayo bevacizumab si loogu daaweeyo bukaanka kansarka beerka ee aan la jari karin ama aan la jari karin ("HCC").
Ansixinta dheeraadka ah ee NDA waxay ku salaysan tahay xog laga helay daraasadda HEPATORCH (NCT04723004), oo ah daraasad caafimaad oo heer caalami ah oo xarun badan leh, aan kala sooc lahayn, calaamad furan, oo firfircoon oo la xakameeyey wejiga 3aad. Professor Jia FAN, oo ah aqoonyahan ka tirsan Akadeemiyada Sayniska Shiinaha, oo ka socda Isbitaalka Zhongshan oo xiriir la leh Jaamacadda Fudan, ayaa u adeegay baare weyn. HEPATORCH waxaa laga bilaabay 57 xarumood oo caafimaad oo ku yaal dhul-weynaha Shiinaha, Taiwan iyo Singapore ee Shiinaha, waxaana la diiwaangeliyey wadarta 326 bukaan. Daraasaddu waxay ujeeddadeedu ahayd in lagu qiimeeyo waxtarka iyo badbaadada toripalimab iyadoo lala kaashanayo bevacizumab si loogu daaweeyo safka koowaad ee HCC aan la jari karin ama aan la jari karin marka la barbar dhigo daaweynta caadiga ah ee sorafenib.
Bishii Sebtembar 2024, natiijooyinka daraasadda HEPATORCH waxay markii ugu horreysay ka soo baxeen Shirweynihii 27-aad ee Caafimaadka Qaranka ee Kansarka iyo Shirweynihii Sannadlaha ahaa ee Bulshada Shiinaha ee Kansarka Caafimaadka (CSCO) ee 2024. Natiijooyinka daraasadda waxay muujiyeen in qodobbada ugu horreeya, badbaadada aan horumarka lahayn ("PFS," oo ku salaysan dib u eegista shucaaca madaxa-bannaan) iyo OS, labaduba waxay gaareen natiijooyin wanaagsan.
HEPATORCH waxay muujisay in marka la barbardhigo sorafenib, toripalimab oo lagu daray bevacizumab ay si weyn u kordhin karto PFS iyo OS ee bukaanada, iyadoo PFS dhexdhexaad ah oo ah 5.8 bilood iyo 4.0 bilood, ay yareyn karto khatarta cudurka ama dhimashada 31% (saamiga khatarta [HR] = 0.69, 95% CI: 0.525-0.913; P = 0.0086), iyadoo OS dhexdhexaad ah oo ah 20.0 bilood iyo 14.5 bilood, ayna yaraynayso khatarta dhimashada 24% (HR = 0.76, 95% CI: 0.579-0.987; P = 0.0394). Heerka jawaab celinta ujeeddada ("ORR") ee kooxda toripalimab iyo bevacizumab wuxuu si weyn uga sarreeyay kan kooxda sorafenib. ORR ee labada kooxood waxay ahaayeen 25.3% iyo 6.1%, siday u kala horreeyaan. Intaa waxaa dheer, daaweynta isku-dhafka ah waxay leedahay astaamo badbaado oo wanaagsan oo loogu talagalay bukaanada qaba HCC-ga horumarsan. Noocyada sunta waxay la jaan qaadayaan noocyada sunta ee la yaqaan ee daaweynta monotherapy-ga caadiga ah, mana jirin calaamad badbaado oo cusub oo la aqoonsaday.
Ku saabsan Toripalimab
Toripalimab waa antibody monoclonal ah oo ka hortagga PD-1 oo loo sameeyay awooddiisa ah inuu xannibo isdhexgalka PD-1 ee ligands-kiisa, PD-L1 iyo PD-L2, iyo inuu kiciyo gudaha soo-dhoweeyaha PD-1 (shaqada endocytosis). Joojinta isdhexgalka PD-1 ee PD-L1 iyo PD-L2 waxay kor u qaadaysaa awoodda habdhiska difaaca jirka ee weerarka iyo dilidda unugyada burooyinka.
In ka badan afartan daraasadood oo kiliinikada toripalimab ah oo ay shirkaddu maalgeliso oo daboolaya in ka badan shan iyo toban tilmaamood ayaa lagu sameeyay adduunka oo dhan Junshi Biosciences, oo ay ku jiraan Shiinaha, Mareykanka, Yurub iyo Koonfur-bari Aasiya. Tijaabooyin caafimaad oo muhiim ah oo socda ama la dhammaystiray oo qiimeynaya badbaadada iyo waxtarka toripalimab waxay daboolayaan noocyo badan oo burooyinka ah, oo ay ku jiraan kansarka sambabka, nasopharynx, hunguriga, caloosha, kaadi haysta, naasaha, beerka, kelyaha, iyo maqaarka.
Dhul-weynaha Shiinaha, toripalimab wuxuu ahaa antibody-gii ugu horreeyay ee gudaha ah ee ka hortagga PD-1 monoclonal antibody oo loo oggolaaday suuq-geynta (oo laga ansixiyay Shiinaha sida TUOYI®). Hadda, waxaa jira kow iyo toban tilmaamood oo la ansixiyay oo loogu talagalay toripalimab dhul-weynaha Shiinaha:
melanoma aan la daaweyn karin ama aan la daaweyn karin ka dib markii uu ku guuldareysto daaweynta nidaamsan ee caadiga ah;
kansarka sanbabada ee soo noqnoqda ama metastatic (NPC) ka dib markii uu ku guuldareysto ugu yaraan laba saf oo daaweyn nidaamsan oo hore;
kansarka kaadi-mareenka ee maxalliga ah ee horumarsan ama metastatic ah oo ku guuldareystay kiimoterabiga ku jira platinum ama sii socday 12 bilood gudahood kemoterabiga ku jira platinum-ka neoadjuvant ama adjuvant;
iyadoo lagu darayo cisplatin iyo gemcitabine oo ah daaweynta koowaad ee bukaanada qaba NPC-ga maxalliga ah ee soo noqnoqda ama soo noqnoqda;
iyadoo lala kaashanayo paclitaxel iyo cisplatin daaweynta safka hore ee bukaanada qaba kansarka unugyada squamous ee aan la tirtiri karin ee maxalliga ah/soo noqnoqda ama fog ee metastatic esophageal squamous cell carcinoma (ESCC);
iyadoo lala kaashanayo pemetrexed iyo platinum oo ah daaweynta safka hore ee isbeddelka EGFR iyo isbeddelka ALK ee taban, aan la tirtiri karin, horumarsan oo maxalli ah ama kansarka sambabada ee aan koonka ahayn ee unugyada yaryar (NSCLC);
iyadoo lagu darayo kiimoterabiga daaweynta qalliinka kadib iyo daaweynta monotherapy oo ah daaweyn dheeraad ah oo loogu talagalay daaweynta bukaanada qaangaarka ah ee leh marxaladda IIIA-IIIB NSCLC ee la jari karo;
iyadoo lala kaashanayo axitinib si loogu daaweeyo bukaanka qaba kansarka unugyada kelyaha ee aan la jari karin ama aan la jari karin (RCC);
iyadoo lagu darayo etoposide iyo platinum si loogu daaweeyo kansarka sambabada ee unugyada yaryar ee heerka ballaaran (ES-SCLC);
iyadoo lala kaashanayo paclitaxel oo loogu talagalay duritaanka (albumin-ku xiran) si loogu daaweeyo kansarka naasaha ee saddex-geesoodka ah ee soo noqnoqda ama metastatic-ka ah (TNBC);
iyadoo lala kaashanayo bevacizumab si loogu daaweeyo bukaanka kansarka beerka ee aan la jari karin ama aan la jari karin (HCC).
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Waqtiga boostada: Maarso-27-2025