Amgen a yau ya sanar da gabatar da inganci da bayanan aminci daga gwajin CodeBreaK 100 Phase 1/2 a cikin marasa lafiya tare da KRAS G12C-mutated ci-gaban ciwon daji na pancreatic wanda ya karɓi LUMAKRAS® (sotorasib). Za a gabatar da bayanan a cikin al'ummar Ofishin Kasar Clinical na wata-wata a ranar 15 ga ASCO a ranar 2022 ga watan Fabrairu, XNUMX
"Dangane da waɗannan bayanai masu ban sha'awa, muna faɗaɗa CodeBreaK 100 don yin rajistar ƙarin marasa lafiya tare da pancreatic da sauran nau'ikan ƙari don ƙarin fahimtar inganci da amincin LUMAKRAS a cikin ciwace-ciwacen ƙwayoyin cuta a waje da ƙananan huhu da kuma ciwon daji," in ji David M. Reese. , MD, mataimakin shugaban zartarwa na Bincike da Ci gaba a Amgen. "CodeBreaK shine mafi girma kuma mafi girman shirin gwaji na asibiti na duniya har zuwa yau tare da ɗayan mafi ƙarfi, bayanan da aka yi bita a tsakiya. Yayin da muke kara koyo daga dimbin bayanan da muke tattarawa, za mu ci gaba da saka hannun jari a cikin shirin ta hanyar fadada kungiyoyin hadin gwiwa da kuma binciko sabbin hanyoyin hadewa domin mu taimaka wa majinyata da yawa gwargwadon iko."
LUMAKRAS ya nuna ƙimar mayar da martani ta tsakiya (ORR) na 21% da ƙimar kula da cututtuka (DCR) na 84% a cikin 38 da aka rigaya an riga an yi maganin ciwon daji na pancreatic. Kusan kashi 80% na marasa lafiya sun karɓi LUMAKRAS azaman layin layi na uku ko kuma daga baya. Takwas daga cikin marasa lafiya na 38 sun sami tabbataccen amsawar juzu'i (PR) da aka yi ta hanyar bita ta tsakiya mai zaman kanta (BICR). Biyu daga cikin marasa lafiya takwas tare da PR suna da martani mai gudana. Tsawon tsaka-tsaki na amsa shine watanni 5.7 tare da bin tsaka-tsaki na watanni 16.8 kamar na ranar yanke bayanai na Nuwamba 1, 2021. Sakamakon kuma ya nuna matsakaicin ci gaba na rayuwa kyauta (PFS) na watanni 4 da matsakaicin rayuwa gabaɗaya ( OS) kusan watanni 7. Ba a gano sabon alamun aminci tare da wannan binciken na marasa lafiya da ciwon daji na pancreatic ba. Abubuwan da ke da alaƙa da jiyya (TRAEs) na kowane nau'i sun faru a cikin 16 (42%) marasa lafiya tare da gudawa (5%) da gajiya (5%) a matsayin mafi yawan sa 3 TRAEs. Babu TRAEs da suka yi kisa ko ya haifar da katsewar magani.
"Bayan shekarun da suka gabata na bincike, jiyya na yanzu ga marasa lafiya da ciwon daji na pancreatic suna ba da iyakacin fa'idar rayuwa, yana nuna mahimmancin buƙatar labari, zaɓuɓɓukan magani mai aminci da inganci," in ji John Strickler, farfesa na likitanci na MD, Makarantar Magunguna ta Jami'ar Duke da kuma likitan cututtukan gastrointestinal. . "A cikin mafi girman bayanan da ke kimanta inganci da amincin mai hanawa KRASG12C a cikin ciwon daji na pancreatic wanda aka riga aka rigaya ya rigaya, sotorasib ya sami matsakaicin adadin amsawar da aka tabbatar na 21% da adadin kula da cututtuka na 84%. Wannan yana da ma'ana ta asibiti ga marasa lafiya saboda babu ƙayyadaddun tsarin jiyya ga waɗannan majiyyatan da zarar sun isa layi na uku na jiyya."
Ciwon daji na pancreatic cuta ce mai saurin kisa. Shi ne babban sanadi na huɗu da ke haifar da mace-mace masu alaƙa da kansa a cikin maza da mata a cikin Amurka tare da adadin rayuwa na shekaru 5 kusan kashi 10%. Akwai babban buƙatu ga marasa lafiya da ke fama da ciwon daji na pancreatic wanda ya ci gaba bayan jiyya na farko, inda FDA ta amince da layin layi na biyu ya ba da rayuwa na kusan watanni shida da ƙimar amsawa na 16%. Bayan ci gaba akan chemotherapy na farko da na biyu, babu hanyoyin kwantar da hankali tare da fa'idar rayuwa. Duk da ci gaban da aka samu a jiyya, an sami 'yan gyare-gyare don inganta ganewar asali da kuma maganin ciwon daji na pancreatic.
An kiyasta cewa kusan kashi 90% na marasa lafiya da ke da ciwon daji na pancreatic suna da tashar maye gurbin KRAS tare da KRAS G12C da ke lissafin kusan 1-2% na waɗannan maye gurbi.
