{"entity":{"id":"azur-1","kind":"trial","name":"AZUR-1","aka":[],"tldr":"AZUR-1 is the registrational trial of the 'no surgery, no radiation, no chemo' approach for mismatch-repair-deficient rectal cancer, built on the MSK study where every patient had a complete response.","summary":"AZUR-1 is a single-arm global trial. It met its primary objective of sustained clinical complete response at 12 months (cCR12); full data due at a 2026 congress. FDA accepted the filing with priority review and a PDUFA date of February 2027, with eligibility for the national priority voucher programme. Breakthrough designation December 2024. Follows the MSK cohort (Cercek, NEJM 2022; >40 consecutive complete responses).","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05723562","url":"https://clinicaltrials.gov/study/NCT05723562"},{"label":"GSK priority review announcement","url":"https://www.gsk.com/en-gb/media/press-releases/jemperli-dostarlimab-accepted-for-priority-review-by-the-us-fda/"}],"tags":[],"related":[],"cancers":["colorectal","msi-high-colorectal","rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":[],"institutions":["mskcc"],"pathways":[],"terms":["msi","clinical-complete-response"],"trials":[],"people":["andrea-cercek"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05723562","phase":"2","setting":"Untreated stage II/III dMMR/MSI-H locally advanced rectal cancer: dostarlimab monotherapy for 6 months, no surgery or radiation if complete response","sponsor":"GSK","result":"Primary endpoint (sustained cCR at 12 months) met; rates pending congress presentation.","started":"2023-04-03","startedType":"actual","yearReported":2026,"enrolled":154,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sustained clinical complete response at 12 months (independent central review)","primary":true,"unit":"%","arms":[{"name":"Dostarlimab monotherapy (single arm)","note":"Primary endpoint met at the interim analysis per the sponsor (13 July 2026); the rate itself is pending congress presentation. Single-arm registrational phase 2."}],"source":"https://www.cancernetwork.com/view/dostarlimab-yields-sustained-complete-responses-in-dmmr-msi-h-rectal-cancer"}],"replication":"Multicentre confirmation of the Memorial Sloan Kettering single-centre cohort (cCR in all 42 evaluable patients, NEJM 2022 / ASCO 2024). FDA granted priority review in August 2026."},"route":"/trials/azur-1/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"msi-high-colorectal","kind":"cancer","name":"Mismatch-repair deficient (MSI-high) colorectal cancer","route":"/cancers/msi-high-colorectal/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"dostarlimab","kind":"drug","name":"Dostarlimab","route":"/drugs/dostarlimab/"}],"institution":[{"id":"mskcc","kind":"institution","name":"Memorial Sloan Kettering Cancer Center","route":"/institutions/mskcc/"}],"term":[{"id":"clinical-complete-response","kind":"term","name":"Clinical complete response (cCR)","route":"/terms/clinical-complete-response/"},{"id":"msi","kind":"term","name":"Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)","route":"/terms/msi/"}],"person":[{"id":"andrea-cercek","kind":"person","name":"Andrea Cercek","route":"/people/andrea-cercek/"}],"pairing":[{"id":"neoadjuvant-io-dmmr","kind":"pairing","name":"Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer","route":"/pairings/neoadjuvant-io-dmmr/"}],"paper":[{"id":"paper-cercek-nonoperative-management-mismatch-repair-deficient-tumours-nejm-2025","kind":"paper","name":"Nonoperative management of mismatch repair-deficient tumors","route":"/key-papers/paper-cercek-nonoperative-management-mismatch-repair-deficient-tumours-nejm-2025/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"},{"id":"surgery-roadmap","kind":"roadmap","name":"Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work","route":"/roadmaps/surgery-roadmap/"}],"idea":[{"id":"idea-fund-organ-preservation-programme","kind":"idea","name":"A funded programme of organ-preservation trials to avoid radical surgery","route":"/ideas/idea-fund-organ-preservation-programme/"},{"id":"idea-crc-organ-preservation-randomised-in-pmmr-rectal","kind":"idea","name":"Randomise organ preservation against surgery in mismatch repair-proficient rectal cancer, with bowel function as a co-primary endpoint","route":"/ideas/idea-crc-organ-preservation-randomised-in-pmmr-rectal/"}],"trial":[{"id":"iwwd","kind":"trial","name":"International Watch & Wait Database","route":"/trials/iwwd/"},{"id":"nct05855200","kind":"trial","name":"Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer","route":"/trials/nct05855200/"}]}}