{"entity":{"id":"codebreak-100","kind":"trial","name":"CodeBreaK 100 (pancreatic cancer cohort)","aka":["CodeBreaK100","CodeBreak 100","AMG 510 phase 1/2"],"tldr":"CodeBreaK 100 gave the first KRAS inhibitor to 38 people whose pancreatic cancer carried the rare G12C mutation and had progressed after chemotherapy; one in five tumours shrank and patients lived a median 6.9 months, proof that KRAS can be drugged in this disease even though the target is uncommon here.","summary":"The pooled phase 1 and 2 pancreatic cohort of CodeBreaK 100 treated 38 patients, all metastatic and previously treated (median two prior lines, range one to eight). Eight had a centrally confirmed objective response (21 percent, 95 percent confidence interval 10 to 37); median progression-free survival was 4.0 months (2.8 to 5.6) and median overall survival 6.9 months (5.0 to 9.1). Treatment-related adverse events occurred in 16 patients (42 percent), grade 3 in six (16 percent), with no fatal events or discontinuations. Sotorasib has no pancreatic indication from the FDA (label: KRAS G12C lung cancer and, with panitumumab, colorectal cancer) or the EMA, and NICE's TA781 covers lung cancer only; NCCN lists sotorasib and adagrasib (KRYSTAL-1: 7 of 21 responses) as options for KRAS G12C pancreatic cancer after first-line therapy, and daraxonrasib, which covers G12C among all RAS G12 mutations, is now approved in the United States for previously treated metastatic disease regardless of subtype.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03600883","url":"https://clinicaltrials.gov/study/NCT03600883"},{"label":"Strickler et al., sotorasib in KRAS p.G12C-mutated advanced pancreatic cancer (NEJM 2023)","url":"https://doi.org/10.1056/NEJMoa2208470"},{"label":"Lumakras label (openFDA): indications, no pancreatic cancer indication","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22LUMAKRAS%22"}],"tags":[],"related":[],"cancers":["pancreatic","kras-g12c-pdac","metastatic-pdac"],"sections":[],"technologies":["kras-inhibitors"],"targets":["kras"],"drugs":["sotorasib"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":["kras-mutation-subtypes"],"trials":["nct03785249","rasolute-302"],"people":["john-strickler"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03600883","phase":"1/2","setting":"Previously treated metastatic KRAS G12C-mutated pancreatic cancer (about 1 to 2 percent of pancreatic tumours), single group: sotorasib 960 mg once daily, with centrally confirmed objective response as the phase 2 primary endpoint","sponsor":"Amgen","result":"Objective response 21 percent (8 of 38; 95 percent confidence interval 10 to 37); median progression-free survival 4.0 months; median overall survival 6.9 months; grade 3 treatment-related adverse events 16 percent.","yearReported":2023,"enrolled":38,"enrolledBasis":"treated","enrolledNote":"ClinicalTrials.gov NCT03600883 lists 713 participants across every tumour cohort of CodeBreaK 100; 38 is the pooled phase 1 and 2 pancreatic cancer cohort treated in the NEJM 2023 report.","outcomes":[{"endpoint":"Objective response (central review)","primary":true,"unit":"%","arms":[{"name":"Sotorasib 960 mg daily","n":38,"value":21,"note":"8 of 38; 95% CI 10 to 37"}],"source":"https://doi.org/10.1056/NEJMoa2208470"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sotorasib 960 mg daily","n":38,"value":6.9,"note":"95% CI 5.0 to 9.1"}],"source":"https://doi.org/10.1056/NEJMoa2208470"}]},"route":"/trials/codebreak-100/","neighbours":{"cancer":[{"id":"kras-g12c-pdac","kind":"cancer","name":"KRAS G12C-mutant pancreatic ductal adenocarcinoma","route":"/cancers/kras-g12c-pdac/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"kras-inhibitors","kind":"technology","name":"KRAS & RAS inhibitors","route":"/technologies/kras-inhibitors/"}],"target":[{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"}],"drug":[{"id":"daraxonrasib","kind":"drug","name":"Daraxonrasib","route":"/drugs/daraxonrasib/"},{"id":"sotorasib","kind":"drug","name":"Sotorasib","route":"/drugs/sotorasib/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"}],"term":[{"id":"kras-mutation-subtypes","kind":"term","name":"KRAS mutation subtypes (G12C, G12D, G12V)","route":"/terms/kras-mutation-subtypes/"}],"trial":[{"id":"nct03785249","kind":"trial","name":"Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1","route":"/trials/nct03785249/"},{"id":"rasolute-302","kind":"trial","name":"RASolute 302","route":"/trials/rasolute-302/"}],"person":[{"id":"john-strickler","kind":"person","name":"John H. Strickler","route":"/people/john-strickler/"}]}}