I-KN026-CSP-001 luphando lwezonyango olungakhethiyo, oluphakathi, lwesigaba II/III ukuvavanya ukusebenza kunye nokhuseleko lwe-KN026 ludityaniswe nechemotherapy kwizigulana ezinomhlaza wesisu se-HER2 (kubandakanywa nomhlaza we-gastroesophageal junction) abangaphumelelanga kumgca wokuqala. unyango, kunye noNjingalwazi Jianming Xu ovela kwiSibhedlele soMkhosi weNkululeko yaBantu baseTshayina njengomphandi oyintloko.
I-GC / GEJ yenye yeethumba eziqhelekileyo ezinobungozi kwaye kukho ngaphezu kwe-1 yezigidi zeemeko ezintsha ngonyaka ngamnye kwihlabathi. Isiganeko somhlaza wesisu siphezulu e-China, malunga neemeko ezintsha ze-410,000 kunye nokufa kwe-294,000 ngonyaka, kubalwa ngaphezu kwe-40% yeemeko ezintsha kunye nokufa kwe-GC / GEJ kwihlabathi jikelele. Umhlaza wesisu e-China ubonakaliswe ngezinga eliphantsi lokuxilongwa komhlaza wesisu sokuqala, umlinganiselo ophezulu wenqanaba le-metastatic (> 80%) kunye neqondo eliphantsi lokusinda kweminyaka emi-5 (malunga ne-35.1%), ebeka engozini ubomi kunye nempilo yabantu. I-HER2 igxininise kakhulu kwiithumba ezininzi, kubandakanywa malunga ne-15-20% kumhlaza wesisu. I-HER2 i-overexpression inxulumene nokuba ndlongondlongo kwethumba kunye ne-prognosis embi. Ngophuhliso lonyango ekujoliswe kulo, i-HER2-positive advanced somhlaza wesisu baye baphumelela ukusebenza ngcono xa kuthelekiswa nechemotherapy yesintu xa benyangwa ngendibaniselwano yamachiza ekujoliswe kuwo. Nakuba kunjalo, kwizigulana ezinomhlaza wesisu esine-HER2 oye waqhubeleka okanye ophinde wavela emva konyango lodidi lokuqala, akukho chiza lisebenzayo elivunyiweyo e-China, kwaye kukho imfuno enkulu yonyango engekafikelelwa.
I-KN026 yi-HER2 ye-bispecific antibody ephuhliswe yi-Alphamab Oncology. Idatha evela kwiSigaba sesi-II sophononongo lwezonyango lwe-KN026, epapashwe e-ASCO ngo-2021, ibonise ukhuseleko oluncomekayo kunye nokusebenza okuthembisayo kwi-HER2 yaseTshayina ebonisa i-GC/GEJ izigulane ezigqithisekileyo, ezithotywe ngonyango okanye ngaphandle kwe-anti HER2. Kwizigulane ezinenkcazo ephezulu, i-ORR yayingu-55.6% kunye ne-DCR yi-72.2%, kunye ne-9-inyanga ye-PFS ye-60.4%. Phakathi kwezigulane ezifumana unyango lwangaphambili lwe-HER2, i-ORR yayiyi-44.4%, kwaye i-DCR yayingu-66.7%. Ukuvunywa kwesicelo solingo lwezonyango sisithintelo sentsebenziswano phakathi kwe-Alphamab Oncology kunye ne-CSPC ukukhawulezisa uphuhliso lwezonyango kunye norhwebo lwe-KN026 kwilizwe laseTshayina. Sinethemba lokubona idatha elungileyo evela kuphononongo, kwaye izise ithemba kwizigulana ezinomhlaza wesisu esinesidingo esingxamisekileyo sokhetho olutsha lonyango.
INTO ONOKUYITHATHA KWELI NQAKU:
- The approval of the clinical trial application is a touchstone for the cooperation between Alphamab Oncology and CSPC to accelerate the clinical development and commercialization of KN026 in mainland China.
- I-KN026-CSP-001 luphando lwezonyango olungakhethiyo, oluphakathi, lwesigaba II/III ukuvavanya ukusebenza kunye nokhuseleko lwe-KN026 ludityaniswe nechemotherapy kwizigulana ezinomhlaza wesisu se-HER2 (kubandakanywa nomhlaza we-gastroesophageal junction) abangaphumelelanga kumgca wokuqala. unyango, kunye noNjingalwazi Jianming Xu ovela kwiSibhedlele soMkhosi weNkululeko yaBantu baseTshayina njengomphandi oyintloko.
- The incidence of gastric cancer is high in China, with about 410,000 new cases and 294,000 deaths each year, accounting for more than 40% of both new and death cases of GC/GEJ worldwide.