The FDA granted accelerated approval to dostarlimab (Jemperli) for adults with stage II or III locally advanced rectal cancer that is MSI-H or mismatch repair-deficient (dMMR). The decision is based on the single-arm AZUR-1 trial in previously untreated patients, where the primary endpoint was sustained clinical complete response (cCR) for 12 months. In AZUR-1, the 12-month cCR rate was 47% by independent central review, with an objective response rate of 79%. Among patients achieving clinical complete response during initial post-treatment assessments, investigators initiated a nonoperative management period under multimodal surveillance. The approval adds another checkpoint-based option to the MSI-H/dMMR rectal cancer pathway and intensifies the ongoing shift toward response-adapted, non-surgical strategies in carefully selected patients.
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