The FDA granted accelerated approval to dostarlimab (Jemperli) for adults with stage II or III locally advanced rectal cancer with MSI-H or dMMR, based on results from the multicenter, single-arm AZUR-1 trial. The study enrolled 154 previously untreated patients and used multimodal imaging and endoscopy for response assessment. In the independent central review of 116 evaluable patients, the 12-month clinical complete response rate (cCR12) was 47%, with an objective response rate of 79%. Notably, after a median follow-up of 26.3 months, patients achieving complete response at assessed timepoints did not experience disease progression. Dostarlimab monotherapy was sufficient for 71% of participants to avoid additional treatment without progression during follow-up. Another 17% proceeded to surgery (with or without additional therapy), while 8% received additional systemic therapy or radiation, reflecting a structured nonoperative management pathway after response.
Get the Daily Brief