Shanghai Henlius Biotech, Inc. ayaa ku dhawaaqday in falanqaynta ku-meel-gaadhka ah ee ugu horreysa ay la kulantay barta ugu dambeysa ee daraasadda guud ee badbaadada (OS) ee daraasadda 3 bukaan-socodka (NCT04063163) ee cusub ee PD-1 inhibitor serplulimab oo ay weheliso kiimoterabi ee bukaannada aan hore loo daaweynin ee leh kansarka sanbabada unugyada yaryar ee heer-balaadhan (ES-SCLC). Ma jiro ka-hortagga PD-1 mAb oo loo oggolaaday daawaynta kansarka sambabada unugyada yaryar ee heer-balaadhan (ES-SCLC) adduunka oo dhan.
Ujeedada ugu weyn ee daraasadda ayaa ah in la sahamiyo waxtarka iyo badbaadada serplulimab oo ay weheliso kiimoterabi ee bukaannada aan hore loo daweyn ee ES-SCLC. Iyada oo ku saleysan natiijooyinka falanqaynta ku-meel-gaadhka ah ee horay loo sii qeexay oo ay samaysay Guddiga Kormeerka Xogta Madaxa-bannaan (IDMC), serplulimab oo lagu daray kiimoterabiga ayaa muujiyay horumar weyn oo OS ah oo ka dhan ah kiimoterabiga, kaas oo la kulmay shuruudaha waxtarka ee horay loo qeexay, oo leh badbaado wanaagsan iyo maya. ogaanshaha calaamad cusub oo badbaado ah. IDMC waxay soo jeedisay in shirkadu ay markaa la xidhiidhi karto maamulka caafimaadka qaba.
SCLC aad bay u xun tahay, daawaynta la heli karaana way xadidan tahay
Marka loo eego xogta GLOBOCAN, kansarka sanbabada (LC) waa kansarka labaad ee sida caadiga ah lagu ogaado adduunka oo dhan wuxuuna xisaabiyaa 11.4% ee dhacdooyinka kansarka adduunka sanadka 2020. sababta ugu weyn ee kansarka iyo dhimashada. SCLC waxay ku xisaabtantaa 810,000%-2020% LC, waana nooca ugu qallafsan ee LC, kaas oo u qaybsan heerka xaddidan ee kansarka sambabada unugyada yaryar (LS-SCLC) iyo ES-SCLC. Bukaanjiifka badankoodu waxay mar horeba ku jireen marxalad ballaaran marka la ogaado. Bukaanka qaba ES-SCLC waxay had iyo jeer leeyihiin korriin buro oo degdeg ah iyo saadaal xumo. Qaar iyaga ka mid ah waxay leeyihiin badbaado gaaban oo ay ugu wacan tahay metastasis ballaaran oo buro ah iyo xaalad jireed oo liita oo keliya oo leh daryeel taageero.
In ka badan 20 sano, etoposide iyo carboplatin / cisplatin ayaa weli ah heerka daryeelka ES-SCLC, laakiin 80% bukaannada qaba cudurka marxaladda xaddidan iyo ku dhawaad dhammaan bukaannada qaba cudurka marxaladda ballaaran waxay soo noqdaan hal sano gudaheed, iyada oo badbaadada dhexdhexaadka ah ee kaliya 4 ilaa 5. 1 bilood ka dib soo noqoshada. Soo ifbaxa horjoogayaasha isbaarada difaaca ayaa bixisa doorasho cusub. Waqtigan xaadirka ah, ka-hortagga PD-L1 mAb oo ay weheliso kiimoterabi ayaa lagu taliyay habraacyadii ugu dambeeyay ee NCCN iyo tilmaamaha CSCO sida daawaynta safka hore ee ES-SCLC. Si kastaba ha ahaatee, codsiga tallaalka difaaca jirka ee ES-SCLC ayaa weli wajahaya caqabado. Sanadihii la soo dhaafay, tiro PD-1 mAbs ah ayaa ku guuldareystay aagga. Sidaa darteed, daaweynta safka hore ee waxtarka leh ee PD-XNUMX inhibitors ayaa si degdeg ah loogu baahan yahay.
Udub dhexaad u ah baahiyaha aan la daboolin ee bukaanka, daboolaya daaweynta safka hore ee dhammaan noocyada kansarka sanbabada
Henlius waxa uu qaatay istiraatijiyad kala duwan "Combo+Global" oo ku saabsan serplulimab. Hadda, serplulimab ayaa loo oggolaaday tijaabooyinka bukaan-socodka ee Shiinaha, Mareykanka, Midowga Yurub iyo dalalka iyo gobollada kale. Wadarta 10-ka daaweynta immuo-oncology ee tijaabooyinka kiliinikada ee serplulimab ayaa socda si loo qiimeeyo badbaadada iyo waxtarkeeda ee noocyo kala duwan oo burooyin adag ah oo daboolaya LC, kansarka hepatocellular, kansarka hunguriga, kansarka unugyada madaxa iyo qoorta squamous cell carcinoma iyo kansarka caloosha iwm. taariikhda, qiyaastii 2300 bukaan ayaa la diiwaan geliyay adduunka oo dhan, taasoo caddaynaysa in tayada serplulimab ay dhistay kalsoonida suuqyada shisheeye. Bishii Abriil, Codsiga Dawooyinka Cusub (NDA) ee serplulimab ee daawaynta burooyinka adag ee MSI-H waxaa aqbalay Maamulka Alaabooyinka Caafimaadka Qaranka (NMPA) waxaana la siiyay dib u eegis mudnaan leh, kaas oo la filayo in la ansixiyo qeybta hore ee 2022.
Marka loo eego sifooyinka bukaannada kansarka labadaba caalamka iyo Shiinaha, shirkaddu waxay diiradda saartaa kansarka sanbabada iyo kansarka mindhicirka oo leh serplulimab oo ah laf dhabarta. Henlius wuxuu ku guuleystey qaabayn caafimaad oo dhamaystiran oo safka koowaad ah ee LC, wuxuuna ku sameeyay tijaabooyin ku saabsan serplulimab ee sqNSCLC, kansarka sambabada unugyada yaryar ee aan-squamous ahayn iyo SCLC, oo daboolaya in ka badan 90% bukaannada kansarka sanbabada. Iyadoo lagu salaynayo randomized, double-inard, international multi-center trials 3 Wajiga . Mustaqbalka, xogta cilmi-baarista caalamiga ah ee badan, Henlius wuxuu sii wadi doonaa ballaarinta qaybinta caalamiga ah ee serplulimab wuxuuna ka faa'iideysan doonaa bukaanno badan oo adduunka ah.
