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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.
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).
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
154 enrolled.
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| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Sustained clinical complete response at 12 months (independent central review)primary | Dostarlimab monotherapy (single arm) | - | 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. | - | - | link |
Shares Andrea Cercek, A funded programme of organ-preservation trials to avoid radical surgery, Nonoperative management of mismatch repair-deficient tumors, Dostarlimab.
Shares Andrea Cercek, Nonoperative management of mismatch repair-deficient tumors, Clinical complete response (cCR), Randomise organ preservation against surgery in mismatch repair-proficient rectal cancer, with bowel function as a co-primary endpoint.
Shares Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer, Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer, Mismatch-repair deficient (MSI-high) colorectal cancer, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR).
Shares Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer, Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer, Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work, Mismatch-repair deficient (MSI-high) colorectal cancer.
Shares International Watch & Wait Database, Clinical complete response (cCR), Randomise organ preservation against surgery in mismatch repair-proficient rectal cancer, with bowel function as a co-primary endpoint, Memorial Sloan Kettering Cancer Center.
Shares Dostarlimab, Mismatch-repair deficient (MSI-high) colorectal cancer, Rectal cancer, Colorectal cancer.
Shares A funded programme of organ-preservation trials to avoid radical surgery, Dostarlimab, Colorectal cancer, Immune checkpoint inhibitors.
Shares Randomise organ preservation against surgery in mismatch repair-proficient rectal cancer, with bowel function as a co-primary endpoint, Memorial Sloan Kettering Cancer Center, 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, Rectal cancer.