U-Amgen namhlanje ubhengeze ukunikezelwa kwedatha esebenzayo kunye nedatha yokhuseleko kwi-CodeBreaK 100 Phase 1/2 yolingo kwizigulane ezine-KRAS G12C-eziguquliweyo zomhlaza we-pancreatic eziphambili ezifumene i-LUKRAS® (sotorasib). Idatha iya kunikezelwa kwi-American Society of Clinical Oncology (ASCO) yePlenary Series ngoFebruwari 15, 2022. Idatha ibonisa umsebenzi okhuthazayo kunye neklinikhi enentsingiselo ye-anticancer kunye nenzuzo enhle: iprofayili yomngcipheko.
"Ngokusekelwe kule datha inomdla, sandisa i-CodeBreaK 100 ukubhalisa izigulane ezininzi ezine-pancreatic kunye nezinye iintlobo ze-tumor ukuze siqonde ngcono ukusebenza kunye nokhuseleko lwe-LUMAKRAS kumathumba angaphandle kweeseli zemiphunga ezingencinci kunye nomhlaza we-colorectal," watsho uDavid M. Reese. , MD, usekela-mongameli olawulayo woPhando kunye noPhuhliso e-Amgen. "I-CodeBreaK yeyona nkqubo inkulu kwaye ibanzi yehlabathi yovavanyo lwezonyango ukuza kuthi ga ngoku kunye nolona lwazi lunamandla, lujongiwe embindini wedatha. Njengoko sifunda ngakumbi kwidatha ebanzi esiyiqokelelayo, siza kuqhubeka nokutyala imali kule nkqubo ngokwandisa amaqela kunye nokujonga indibaniselwano emitsha ukuze sikwazi ukunceda izigulana ezininzi kangangoko sinako.
I-LUKRAS ibonise inqanaba lempendulo yenjongo eqinisekisiweyo ephakathi (ORR) ye-21% kunye nezinga lokulawula isifo (DCR) lama-84% kwizigulane ezingama-38 ezinyangelwe kakhulu kwangaphambili zomhlaza we-pancreatic. Phantse i-80% yezigulane zafumana i-LUKRAS njengonyango lodidi lwesithathu okanye unyango lwamva. Izigulane ezisibhozo kwezingama-38 zifumene impendulo engaphelelanga eqinisekisiweyo (PR) eyenziwa ngophononongo oluzimeleyo oluyimfama (BICR). Izigulane ezimbini kwezisibhozo ezine-PR zineempendulo eziqhubekayo. Ubude bexesha eliphakathi lokuphendula laliziinyanga ze-5.7 kunye nokulandelelwa okuphakathi kweenyanga ze-16.8 ukususela ngomhla we-data cutoff ngomhla we-Nov. 1, 2021. Iziphumo zikwabonisa i-median progression free survival (PFS) yeenyanga ze-4 kunye ne-median jikelele yokuphila ( OS) phantse iinyanga ezisi-7. Akukho miqondiso mitsha yokhuseleko ichongiwe kolu phononongo lwezigulane ezinomhlaza wepancreatic. Iziganeko ezimbi ezinxulumene nonyango (TRAEs) zaliphi na ibakala zenzeke kwi-16 (42%) izigulane ezine-diarrhea (5%) kunye nokukhathala (5%) njengeyona nto iqhelekileyo ye-TRAEs ye-3. Akukho zi-TRAEs eziye zabulala okanye zakhokelela ekuyekisweni konyango.
"Emva kwamashumi eminyaka yophando, unyango lwangoku lwezigulane ezinomhlaza we-pancreatic lubonelela ngenzuzo elinganiselweyo yokuphila, ebonisa imfuno ebalulekileyo yenoveli, ukhetho olukhuselekileyo nolusebenzayo zonyango," utshilo uJohn Strickler, unjingalwazi onxulumene nezonyango, iDuke University School of Medicine kunye ne-oncologist yesisu. . "Kwidatha enkulu evavanya ukusebenza kunye nokhuseleko lwe-KRASG12C inhibitor kumhlaza wepancreatic onyangelwe kakhulu, i-sotorasib iphumelele inqanaba lokuphendula eliqinisekisiweyo le-21% kunye nenqanaba lolawulo lwesifo lama-84%. Oku kunentsingiselo ngokwezonyango kwizigulana kuba akukho nyango lumiselweyo olumiselweyo kwezi zigulana nje ukuba zifike kudidi lwesithathu lonyango.”
Umhlaza wepancreas sisifo esibulala kakhulu. Ingowesine unobangela wokusweleka okunxulumene nomhlaza kumadoda nabasetyhini e-US abanezinga lokusinda leminyaka emi-5 malunga ne-10%. Kukho imfuneko ephezulu engafezekiswanga yezigulane ezinomhlaza wepancreatic oqhubela phambili emva konyango lodidi lokuqala, apho unyango lodidi lwesibini oluvunywe yi-FDA lubonelele ngempilo emalunga neenyanga ezintandathu kunye nezinga lokuphendula le-16%. Emva kokuqhubela phambili kwi-chemotherapy yomgca wokuqala nowesibini, akukho nyango lubonisa inzuzo yokusinda. Ngaphandle kokuhambela phambili kunyango, uphuculo olumbalwa lwenziwe ukuphucula ukuxilongwa kunye nokunyangwa komhlaza we-pancreatic.
Kuqikelelwa ukuba malunga ne-90% yezigulana ezinomhlaza wepancreatic zinotshintsho lwe-KRAS kunye ne-KRAS G12C ethatha malunga ne-1-2% yolu tshintsho.
