Penpulimab waxay heshay Ansixinta NMPA ee Daaweynta Khadka Koowaad ee Kansarka Sanka

Maarso 16, 2025, Akeso waxay ku dhawaaqday in antibody-geeda cusub ee iskiis u horumarsan ee ka hortagga PD-1 monoclonal antibody, penpulimab, ay si rasmi ah u ansixisay Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) si loogu daaweeyo kansarka sanbabada ee soo noqnoqda ama metastatic metastatic (NPC) iyadoo lala kaashanayo kiimoterabiga.

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Penpulimab (PD-1 Monoclonal Antibody) hadda waa antibody-ga kaliya ee kala duwan ee PD-1 monoclonal kaas oo adeegsada nooca IgG1 oo leh Fc-nulldomain wax laga beddelay, kaas oo si wax ku ool ah u xoojin kara waxtarka difaaca jirka isla markaana yareyn kara falcelinta xun ee la xiriirta difaaca jirka. Waxaa loo isticmaalaa daaweynta cudurrada waaweyn sida kansarka sambabada, lymphoma, kansarka sanbabada, kansarka beerka, iyo kansarka caloosha, iyadoo la wanaajiyay badbaadada iyo waxtarka sida lagu muujiyay daraasadaha kiliinikada.

Tani waxay calaamad u tahay tilmaantii afraad ee la ansixiyay ee penpulimab. Marka laga soo tago labada tilmaamood ee NPC, penpulimab waxaa sidoo kale loo oggolaaday daawaynta safka hore ee kansarka sambabka ee unugyada yaryar ee unugyada yaryar (NSCLC) ee maxalliga ah ee horumarsan ama metastatic marka lagu daro kiimoterabiga, iyo sidoo kale daaweynta degdegga ah ee bukaanada qaba lymphoma-ka Hodgkin ee caadiga ah ee soo noqnoqda ama aan firfircoonayn (cHL) kuwaas oo hore u helay ugu yaraan laba xariiq oo kiimoterabiga nidaamsan ah. Intaa waxaa dheer, Codsiga Daawada Cusub ee Dheeraadka ah (sNDA) ee penpulimab oo lagu daray anlotinib si loogu daaweeyo safka hore ee kansarka beerka ee horumarsan (HCC) ayaa hadda dib loo eegayaa.

Horey, penpulimab waxaa loo ansixiyay in loo isticmaalo daawaynta safka saddexaad ee NPC-ga horumarsan. Iyada oo la raacayo oggolaanshahan cusub, penpulimab hadda waxay bixisaa daboolid daaweyn oo dhammaystiran dhammaan marxaladaha NPC, iyadoo bukaanada siinaysa ikhtiyaar daaweyn difaac oo joogto ah laga bilaabo daaweynta safka koowaad ilaa safka saddexaad.

Juun 19, 2024, "Signal Transduction iyo Bartilmaameed Daawaynta" waxay daabacday natiijooyinka daraasad wejiga II ah oo ku saabsan daaweynta kansarka nasopharyngeal ee hore loo daweeyay oo leh pembrolizumab.

Tijaabadan hal-gacan, wejiga labaad ee lagu sameeyay 20 xarumood oo daryeelka sare ah oo ku yaal Shiinaha ayaa lagu diiwaangeliyay bukaanada qaangaarka ah ee qaba kansarka nasopharyngeal (NPC) ee metastatic metastatic kuwaas oo ku dhacay laba ama in ka badan oo ah kiimoterabiga nidaamsan ee hore. Bukaannada waxay si xidid ah u qaateen 200-mg penpulimab 2dii toddobaadba mar (4 toddobaad wareeg kasta) ilaa uu cudurku sii kordho ama sun aan loo dulqaadan karin. Dhibcaha ugu horreeya waxay ahaayeen heerka jawaab celinta ujeedka ah (ORR) halkii RECIST (nooca 1.1), sida ay qiimeeyeen guddi dib u eegis shucaac oo madax-bannaan. Dhibcaha labaad waxaa ka mid ahaa badbaadada aan horumarka lahayn (PFS) iyo badbaadada guud (OS). Boqol iyo soddon bukaan ayaa la diiwaan geliyay 125-na waxaa lagu qiimeeyay waxtarka. Taariikhda goynta xogta (Sebtembar 28, 2022), 1 bukaan ayaa gaaray jawaab dhammaystiran 34 bukaanna waxay heleen jawaab qayb ahaan ah. ORR wuxuu ahaa 28.0% (95% CI 20.3–36.7%). Jawaabtu waxay ahayd mid waara, iyadoo 66.8% ay wali jawaab celin ku jiraan 9 bilood. Saddex iyo soddon bukaan (26.4%) ayaa wali ku jiray daawaynta. Celceliska PFS iyo OS waxay ahaayeen 3.6 bilood (95% CI = 1.9–7.3 bilood) iyo 22.8 bilood (95% CI = 17.1 bilood si aan loo gaarin), siday u kala horreeyaan. Toban (7.6%) bukaan ayaa la kulmay irAEs heerka 3aad ama ka sareeya. Penpulimab waxay leedahay hawlo rajo leh oo ka hortagga burooyinka iyo sunta la aqbali karo ee bukaanada NPC ee si aad ah loo daaweeyay, taasoo taageerta horumar caafimaad oo dheeraad ah oo ah daaweynta safka saddexaad ee NPC-ga metastatic.

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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: Abriil-25-2025