# AZUR-1

Source: https://onco.cc/trials/azur-1/  
OnCo record `azur-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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).

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: 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
- Enrolled: 154
- Result: Primary endpoint (sustained cCR at 12 months) met; rates pending congress presentation.
- Outcomes: Sustained clinical complete response at 12 months (independent central review): Dostarlimab monotherapy (single arm)
- 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.

## Sources

- ClinicalTrials.gov NCT05723562: https://clinicaltrials.gov/study/NCT05723562
- GSK priority review announcement: https://www.gsk.com/en-gb/media/press-releases/jemperli-dostarlimab-accepted-for-priority-review-by-the-us-fda/

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Mismatch-repair deficient (MSI-high) colorectal cancer](https://onco.cc/cancers/msi-high-colorectal/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Dostarlimab](https://onco.cc/drugs/dostarlimab/)
- institutions: [Memorial Sloan Kettering Cancer Center](https://onco.cc/institutions/mskcc/)
- terms: [Clinical complete response (cCR)](https://onco.cc/terms/clinical-complete-response/), [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/)
- people: [Andrea Cercek](https://onco.cc/people/andrea-cercek/)
- pairings: [Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer](https://onco.cc/pairings/neoadjuvant-io-dmmr/)
- key papers: [Nonoperative management of mismatch repair-deficient tumors](https://onco.cc/key-papers/paper-cercek-nonoperative-management-mismatch-repair-deficient-tumours-nejm-2025/)
- roadmaps: [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](https://onco.cc/roadmaps/colorectal-roadmap/), [Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work](https://onco.cc/roadmaps/surgery-roadmap/)
- ideas: [A funded programme of organ-preservation trials to avoid radical surgery](https://onco.cc/ideas/idea-fund-organ-preservation-programme/), [Randomise organ preservation against surgery in mismatch repair-proficient rectal cancer, with bowel function as a co-primary endpoint](https://onco.cc/ideas/idea-crc-organ-preservation-randomised-in-pmmr-rectal/)
- trials: [International Watch & Wait Database](https://onco.cc/trials/iwwd/), [Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer](https://onco.cc/trials/nct05855200/)

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