Ua hoʻolaha ʻo Amgen i kēia lā i ka hōʻike ʻana i ka ʻikepili pono a me ka palekana mai ka CodeBreaK 100 Phase 1/2 hoʻāʻo i nā mea maʻi me KRAS G12C-mutated advanced pancreatic cancer i loaʻa iā LUMAKRAS® (sotorasib). E hōʻike ʻia ka ʻikepili i kēlā me kēia mahina ʻAmelika Hui Pū ʻIa o Clinical Oncology (ASCO) Plenary Series ma Feb. 15, 2022. Hōʻike ka ʻikepili i ka hana anticancer hoʻoikaika a me ka hoʻoikaika kino kino a me kahi pōmaikaʻi maikaʻi: ʻike pilikino.
"Ma muli o kēia mau ʻikepili hoihoi, ke hoʻonui nei mākou i ka CodeBreaK 100 e hoʻopaʻa inoa i nā mea maʻi me ka pancreatic a me nā ʻano tumo ʻē aʻe e hoʻomaopopo maikaʻi i ka pono a me ka palekana o LUMAKRAS i nā maʻi maʻi ma waho o nā pūpū liʻiliʻi liʻiliʻi a me nā maʻi maʻi colorectal," wahi a David M. Reese , MD, hope pelekikena hoʻokō o Research and Development ma Amgen. "ʻO CodeBreaK ka papahana hoʻokolohua lapaʻau nui loa a ākea loa a hiki i kēia lā me kekahi o nā ʻikepili koʻikoʻi i loiloi ʻia. Ke aʻo hou nei mākou mai ka ʻikepili nui a mākou e hōʻiliʻili ai, e hoʻomau mākou i ka hoʻopukapuka kālā i ka papahana ma o ka hoʻonui ʻana i nā cohorts a me ka ʻimi ʻana i nā hui hou i hiki iā mākou ke kōkua i nā mea maʻi e like me ka hiki.
Ua hōʻike ʻo LUMAKRAS i ka helu o ka pane ʻana i ka pahuhopu (ORR) o 21% a me ka helu hoʻomalu maʻi (DCR) o 84% ma waena o 38 mau mea maʻi maʻi maʻi maʻi pancreatic holomua. Ma kahi kokoke i 80% o nā maʻi i loaʻa iā LUMAKRAS ma ke ʻano he kolu o ka lāʻau lapaʻau a ma hope paha. ʻEwalu o nā maʻi 38 i loaʻa i kahi pane ʻāpana i hoʻopaʻa ʻia (PR) i hana ʻia e kahi loiloi kikowaena kūʻokoʻa makapō (BICR). ʻElua o nā maʻi ʻewalu me PR e mau ana nā pane. ʻO ka lōʻihi o ka pane ʻana he 5.7 mahina me ka hahai ʻana ma waena o 16.8 mahina mai ka lā ʻoki ʻikepili o Nov. 1, 2021. Hōʻike pū nā hopena i ka median progression free survival (PFS) o 4 mau mahina a me ke ola holoʻokoʻa. OS) kokoke i 7 mahina. ʻAʻohe hōʻailona palekana hou i ʻike ʻia me kēia noiʻi ʻana i nā poʻe maʻi me nā maʻi maʻi pancreatic holomua. Loaʻa nā hanana ʻino e pili ana i ka lāʻau (TRAE) o kēlā me kēia papa ma 16 (42%) nā mea maʻi me ka maʻi maʻi maʻi (5%) a me ka luhi (5%) ma ke ʻano he 3 TRAE maʻamau. ʻAʻohe TRAE i make a i hoʻopau ʻia ka mālama ʻana.
"Ma hope o nā makahiki he nui o ka noiʻi ʻana, ʻo ka mālama ʻana i kēia manawa no ka poʻe maʻi me ka maʻi maʻi pancreatic e hāʻawi i ka pōmaikaʻi ola liʻiliʻi, e hōʻike ana i ka pono koʻikoʻi no ka moʻolelo, palekana a maikaʻi hoʻi nā koho lapaʻau," wahi a John Strickler, MD hoa kaukaʻi o ka lāʻau lapaʻau, Duke University School of Medicine and gastrointestinal oncologist. . "I loko o ka ʻikepili nui loa e loiloi ana i ka maikaʻi a me ka palekana o kahi inhibitor KRASG12C i ka maʻi maʻi pancreatic holomua pretreated, ua hoʻokō ʻo sotorasib i kahi helu pane i hoʻopaʻa ʻia i waena o 21% a me kahi helu hoʻomalu maʻi o 84%. He mea koʻikoʻi kēia no ka poʻe maʻi no ka mea ʻaʻole i hoʻokumu ʻia kahi lāʻau lapaʻau maʻamau no kēia mau maʻi i ka wā i hiki ai lākou i kahi laina ʻekolu o ka lāʻau lapaʻau.
ʻO ka maʻi maʻi o ka pancreas kahi maʻi ʻino nui loa. ʻO ia ke kumu nui ʻehā o ka make e pili ana i ka maʻi kanesa i nā kāne a me nā wahine ma US me kahi ola ola 5 makahiki ma kahi o 10%. Loaʻa kahi pono kūpono ʻole no nā poʻe maʻi me ka maʻi maʻi pancreatic holomua i holomua ma hope o ka lāʻau lapaʻau mua, kahi i hoʻolako ʻia ai ka lāʻau lapaʻau lua i ʻae ʻia e FDA i ke ola ma kahi o ʻeono mahina a me ka helu pane o 16%. Ma hope o ka holomua ʻana i ka chemotherapy laina mua a me ka lua, ʻaʻohe lāʻau lapaʻau me kahi pōmaikaʻi ola i hōʻike ʻia. ʻOiai ka holomua o ka mālama ʻana, ua liʻiliʻi nā hoʻomaikaʻi e hoʻomaikaʻi i ka maʻi maʻi a me ka mālama ʻana i ka maʻi maʻi pancreatic.
Ua manaʻo ʻia aia ma kahi o 90% o nā mea maʻi me ka maʻi maʻi pancreatic i hoʻololi i ka KRAS me KRAS G12C e helu ana ma kahi o 1-2% o kēia mau hoʻololi.
