Steven D Wexner MD, PhD

An important milestone in rectal cancer care: the @FDA has granted accelerated approval of dostarlimab for adults with previously untreated stage II or III dMMR/MSI-H locally advanced rectal cancer. In 2022, the initial @NEJM report found a clinical complete response in all 12 patients who completed six months of dostarlimab. The result was striking, but came from a small cohort. The 2025 NEJM report expanded the evidence: all 49 patients with rectal cancer who completed treatment had a clinical complete response and chose nonoperative management. Two-year recurrence-free survival was 96% in this cohort. The approval was based primarily on AZUR-1, a multicenter phase 2 trial of 154 patients, with supporting data from the NEJM study. For eligible patients, this approach may help avoid chemoradiation and surgery, underscoring the importance of routine MMR/MSI testing at diagnosis. Close surveillance by an experienced multidisciplinary team remains critical, and longer follow-up is needed to confirm durability. #RectalCancer #Immunotherapy #ColorectalCancer #PrecisionOncology @AndreaCercek @MSKCancerCenter @ASCO @ASCRS_1 @GaertnerWB @SWexner