The FDA granted accelerated approval to dostarlimab (Jemperli) as first-line therapy for adults with stage II or III locally advanced rectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR). The decision was based on results from the single-arm, open-label AZUR-1 trial. Across 154 previously untreated patients, the study reported a 12-month clinical complete response rate of 47% (by independent central review) and an objective response rate of 79%. Among patients evaluable by central review, the company said those with clinical complete responses did not experience disease progression during follow-up. The label includes a nonoperative management pathway for patients achieving clinical complete response after initial assessments. The trial design incorporated multimodal monitoring, including endoscopy and imaging, with escalation to standard-of-care when patients did not meet response criteria.