Diseembar 04, 2024, Codsiga Daawada Cusub (NDA) ee isku-darka TYVYT® (durista sintilimab) iyo ELUNATE® (fruquintinib) ayaa laga siiyay Shiinaha ogolaansho shuruudaysan oo loogu talagalay daaweynta bukaanada qaba kansarka endometrial-ka ee horumarsan oo leh burooyinka Mismatch Repair proficient (pMMR) kuwaas oo ku guuldareystay daaweynta nidaamsan ee hore oo aan ahayn musharaxiinta qalliinka daaweynta ama shucaaca. Ansixintan waxay raacaysaa xaaladda dib u eegista mudnaanta leh iyo magacaabista daaweynta horumarsan ee Maamulka Qaranka ee Badeecadaha Caafimaadka (NMPA) ee Shiinaha waxayna calaamad u tahay tilmaanta siddeedaad ee la ansixiyay ee TYVYT® (durista sintilimab).
Ansixinta shuruudaysan ee NMPA waxaa taageeray xogta marxaladda diiwaangelinta ee FRUSICA-1, oo ah koox diiwaangelin kansar endometrial ah oo ka tirsan daraasad furan oo Wajiga 2 ah oo lagu baarayo sintilimab oo lagu daray fruquintinib bukaannada kansarka endometrial ee la kulmay soo noqoshada cudurka, horumarka cudurka ama sun aan loo dulqaadan karin iyadoo la adeegsanayo daaweynta kiimoterabiga labajibbaaran ee ku salaysan platinum. Natiijooyinka ka soo baxay FRUSICA-1 waxaa lagu soo bandhigay shirkii sanadlaha ahaa ee Bulshada Mareykanka ee Kiliinikada Oncology bishii Juun 2024.
AWadarta guud ee 98 dhibcood oo leh xaaladda pMMR ayaa la diiwaan geliyay waxaana la siiyay daawaynta isku dhafan. Dhammaan bukaannada ayaa hore u helay ugu yaraan daaweynta nidaamsan ee platinum-ka ku jira safka hore, 22.4% bukaannada ayaa helay daaweynta bevacizumab. Taariikhaha cudurrada ee faahfaahsan ayaa lagu soo koobay jadwalka. Iyada oo muddada dabagalka dhexdhexaadka ah (95% CI) ay ahayd 15.7m (14.6, 17.7), 87/98 bukaannada ayaa lahaa ugu yaraan hal natiijo oo qiimeyn burooyinka ka dib bilowga (dhibco qiimeyn waxtar leh), kuwaas oo ka mid ah, ORR iyo DCR-ka IRC-ga lagu qiimeeyay waxay ahaayeen 35.6% (CR: 2/87 iyo PR: 29/87) iyo 88.5% siday u kala horreeyaan; DoR lama gaarin heerka 9m-DoR-na wuxuu ahaa 80.7%. 98 dhibcood gudahood, celceliska (95% CI) PFS iyo OS waxay ahaayeen 9.5m (5.6, -) iyo 21.3m (17.3, -) siday u kala horreeyaan. Iyada oo lagu saleynayo daaweynta bevacizumab ee hore, ORR waxay ahayd 40.9% marka loo eego 30.3%, dhexdhexaadka (95% CI) PFS-na wuxuu ahaa 13.8m (4.1, -) marka loo eego 9.5m (5.5, -).
Dhacdooyinka xun waxay la jaan qaadayaan kuwa lagu soo sheegay daawaynta isku-dhafka ah ee difaaca jirka iyo daawooyinka ka hortagga anjiojiinta.
Ku saabsan Sintilimab
Sintilimab, oo loo suuq geeyo TYVYT (durista sintilimab) ee Shiinaha, waa antibody monoclonal PD-1 immunoglobulin G4 oo ay si wadajir ah u sameeyeen Innovent iyo Eli Lilly iyo Company. Sintilimab waa nooc ka mid ah antibody-ga immunoglobulin G4 monoclonal, kaas oo ku xidha molecules-ka PD-1 ee dusha sare ee unugyada T, wuxuu xannibaa marinnada PD-1 / PD-Ligand 1 (PD-L1), wuxuuna dib u kiciyaa unugyada T si ay u dilaan unugyada kansarka. Shiinaha, sintilimab waa la ansixiyay waxaana lagu daray NRDL-ka la cusbooneysiiyay toddobo tilmaamood. Baaxadda magdhowga NRDL ee la cusbooneysiiyay ee duritaanka TYVYT (sintilimab) waxaa ka mid ah:
Daaweynta lymphoma-ka Hodgkin ee soo noqnoqda ama aan firfircoonayn ka dib laba xariiq ama ka dib oo ah kiimoterabiga nidaamsan;
Daaweynta safka hore ee kansarka sambabada ee aan la tirtiri karin ee maxalliga ah ama kansarka unugyada yaryar ee aan lahayn unugyada yaryar ee aan lahayn isbeddellada hidde-sidaha ee darawalka EGFR ama ALK;
Daaweynta bukaanada qaba kansarka sambabada ee unugyada yaryar ee aan ahayn kuwa aan ahayn kuwa aan ahayn kuwa EGFR ee ku dhacay kansarka gudaha ama kansarka sambabada ee aan ahayn kuwa aan ahayn kuwa aan ahayn kuwa aan ahayn kuwa aan ahayn kuwa aan ahayn kuwa EGFR-TKI ee ku dhacay kansarka sambabada ee aan ahayn kuwa EGFR-TKI;
Daaweynta safka hore ee kansarka sambabka ee aan la tirtiri karin ee maxalliga ah ama kansarka unugyada yaryar ee aan la jari karin;
Daaweynta safka hore ee kansarka beerka ee aan la jari karin ama aan la jari karin iyada oo aan lahayn daaweyn nidaamsan oo hore;
Daaweynta safka hore ee kansarka unugyada squamous ee aan la tirtiri karin ee maxalliga ah, soo noqnoqda ama metastatic esophageal;
Daaweynta safka hore ee kansarka caloosha ama caloosha ee aan la tirtiri karin ee maxalliga ah, soo noqnoqda ama metastatic ah.
Intaa waxaa dheer, calaamadda siddeedaad ee sintilimab, oo ay weheliso fruquintinib oo loogu talagalay daaweynta bukaanada qaba kansarka endometrial-ka ee horumarsan ee qaba burooyinka pMMR kuwaas oo ku guuldareystay daaweynta nidaamsan ee hore oo aan ahayn musharaxiinta qalliinka daaweynta ama shucaaca, waxaa ansixiyay NMPA bishii Diseembar 2024.
Intaa waxaa dheer, laba daraasadood oo caafimaad oo ku saabsan sintilimab ayaa la kulmay natiijooyinkoodii ugu horreeyay:
Daraasadda wejiga 2aad ee daaweynta sintilimab monotherapy oo ah daaweynta safka labaad ee kansarka unugyada squamous ee hunguriga;
Daraasadda wejiga 3aad ee daaweynta sintilimab monotherapy oo ah daaweynta labaad ee kansarka sambabada ee unugyada yaryar ee aan squamous ahayn oo leh cudur sii kordhaya ka dib kiimoterabiga ku salaysan platinum.
Ku saabsan Fruquintinib
Fruquintinib waa daawo afka laga qaato oo ka hortagta dhammaan saddexda qaybood ee soo-dhoweeyaha koritaanka xididdada dhiigga ("VEGF") (VEGFR-1, -2 iyo -3). Daawooyinka joojiya VEGFR waxay door muhiim ah ka ciyaaraan joojinta angiogenesis-ka burooyinka. Fruquintinib waxaa loogu talagalay inuu yeesho xulasho la xoojiyay oo xaddidaysa dhaqdhaqaaqa kinase-ka ee ka baxsan bartilmaameedka, taasoo u oggolaanaysa soo-gaadhista daroogada oo gaarta joojinta bartilmaameedka joogtada ah iyo dabacsanaanta isticmaalka suurtagalka ah iyadoo qayb ka ah daaweynta isku-darka ah.
Fruquintinib waxaa loo oggolaaday suuqgeynta daaweynta bukaanada qaba kansarka mindhicirka ee metastatic kuwaas oo hore u qaatay fluoropyrimidine, oxaliplatin iyo kiimoterabiga ku salaysan irinotecan, iyo kuwa hore u qaatay ama aan ku habboonayn helitaanka daaweynta anti-VEGF ama daaweynta anti-epidermal growth factor receptor ("EGFR") (RAS wild-type) ee Shiinaha, halkaas oo ay si wada jir ah u sameeyeen oo ay si wada jir ah u suuq-geeyeen HUTCHMED iyo Eli Lilly iyo Company oo leh magaca summada ELUNATE. Waxaa lagu daray Liiska Dawooyinka Lacag-bixinta Qaranka ee Shiinaha ("NRDL") bishii Janaayo 2020. Tan iyo markii laga bilaabay Shiinaha, in ka badan 100,000 oo bukaan ah oo qaba kansarka mindhicirka ayaa lagu daweeyay fruquintinib.
Bishii Diseembar 2024, fruquintinib waxaa ansixiyay NMPA iyadoo lagu daray sintilimab si loogu daaweeyo bukaanada qaba kansarka endometrial-ka ee horumarsan ee qaba burooyinka pMMR kuwaas oo ku guuldareystay daaweynta nidaamsan ee hore oo aan ahayn musharaxiinta qalliinka daaweynta ama shucaaca.
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.
Lambarka Taleefanka: 4008803716
Iimayl:myimmnet@163.com
Tixraacyada
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241203153537120.html
2.https://cn.innoventbio.com/#/news/592
3.https://meetings.asco.org/abstracts-presentations/234546
4.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
5.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
Waqtiga boostada: Diseembar-16-2024