AZUR-1
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).
Pages like this
not linked directly; found by shared links- Key paperCercek 2022: six months of dostarlimab alone made rectal cancer disappear in every patient with mismatch-repair deficiency
Shares Andrea Cercek, Dostarlimab, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Memorial Sloan Kettering Cancer Center.
- Key paperDostarlimab alone cures mismatch-repair-deficient rectal cancer without surgery or radiotherapy
Shares Andrea Cercek, Dostarlimab, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Memorial Sloan Kettering Cancer Center.
- TrialATOMIC (Alliance A021502)
Shares Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Colorectal cancer.
- TrialNICHE-2
Shares Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Colorectal cancer.
- IdeaA funded programme of organ-preservation trials to avoid radical surgery
Shares Dostarlimab, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Colorectal cancer.
- PersonLuis A. Diaz Jr.
Shares Dostarlimab, Memorial Sloan Kettering Cancer Center, Colorectal cancer.
- TrialRUBY / ENGOT-EN6 / GOG-3031
Shares Dostarlimab, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR).
- PairingChemotherapy + PD-1/PD-L1 blockade, first-line advanced endometrial cancer
Shares Dostarlimab, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR).