AZUR-1 — dostarlimab monotherapy in dMMR/MSI-H locally advanced rectal cancer

What is being studied? AZUR-1 studies dostarlimab immunotherapy alone in locally advanced rectal cancer with a specific molecular feature (dMMR/MSI-H). The aim is to shrink the tumor completely in suitable patients and potentially reduce the need for surgery and radiotherapy.

Why does it matter? Some patients achieved durable clinical complete responses. On 19 October 2026 the FDA granted accelerated approval to dostarlimab for this patient group. That approval applies in the United States.

Does this mean every patient can avoid surgery? No. In the study, some patients still needed surgery or other cancer treatments. Even after a clinical complete response, close follow-up with regular MRI, endoscopy, and other assessments is required.

What is not proven? Long-term recurrence risk, durable organ-preservation rates, overall survival, and late immunotherapy effects still need longer follow-up. Confirmatory obligations for accelerated approval continue (FDA: study completion target October 2029; final report July 2030).

Is this an available treatment today? Dostarlimab has accelerated FDA approval in the US for stage II–III dMMR/MSI-H locally advanced rectal cancer. Treatment decisions still depend on molecular features, the patient’s condition, and multidisciplinary assessment. License and access in Turkey must be evaluated separately.

n=154; single-arm; enrollment closed. Annals: INV cCR12 ~68% (≥12 mo FU); FDA label ICR cCR12 47% (n=116; 95% CI 37–56 — GSK/Annals; some FDA texts list 27–56). AA: 19 Oct 2026 (US). Confirmatory obligations through 2029/2030. Read with the pioneering MSK cohort — not as a separate second gold star.

Cancer / population: Rectum — Tedavi almamış evre II–III dMMR/MSI-H LARC

Intervention: Dostarlimab 500 mg Q3W × 9; cCR’de NOM

Primary endpoint: 12 ay sürdürülebilir cCR (ICR/investigator)

Source-verified summary: FDA AA 2026-10-19 (US). Label ICR cCR12 %47 (n=116); %95 GA 37–56 (GSK/Annals; bazı FDA metinlerinde 27–56 geçer). Annals INV cCR12 ~%68 (≥12 ay izlem). PMR: tamamlanma hedefi Eki 2029; nihai rapor Tem 2030. MSK öncü kohorta ikinci bağımsız yıldız değildir.

Limitations: Tek kollu; ICR vs INV cCR ayrışması; hızlandırılmış onay + tamamlanmamış doğrulama (2029/2030); MSK erken kohort oranlarıyla karıştırılmamalı; Türkiye ruhsatı ayrı.