Mel Mann, Patient Advocate, Chronic Myeloid Leukemia Survivor, shared on X:
“What if some rectal cancer patients could skip surgery, radiation, and chemo?
That’s what the AZUR-1 trial explored with dostarlimab (Jemperli) in dMMR/MSI-H locally advanced rectal cancer.
After more than two years of follow-up, nearly three-quarters of patients had not needed those treatments. FDA granted accelerated approval.
More data will come, but the early signal is striking for a disease that usually requires intensive therapy.”
More information on AZUR-1 trial
The phase II AZUR-1 trial is evaluating dostarlimab monotherapy in approximately 150 patients with previously untreated, locally advanced stage II/III mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer.
Participants receive intravenous dostarlimab 500 mg every three weeks for nine cycles.
- The primary endpoint is clinical complete response (cCR) at 12 months, assessed by independent central review.
- Secondary endpoints include sustained complete response at 24 and 36 months, three-year event-free survival, organ preservation, and five-year disease-specific and overall survival.
The study aims to establish the efficacy and safety of immunotherapy and assess its potential to support non-operative management.
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Mel Mann: How the ACCESS Trial Brings a ‘Donor for All’ Closer to Reality – OncoDaily
Nabil Ismaili: AZUR-1 Puts Organ Preservation in Focus at ESMO 2026
AZUR-1 at ESMO 2026: Dostarlimab monotherapy in dMMR/MSI-H Locally Advanced Rectal Cancer