The phase 2 AZUR-1 trial has met its main goal, showing that dostarlimab (Jemperli) alone can produce a lasting complete response in patients with stage II/III dMMR/MSI-H locally advanced rectal cancer.
An interim analysis found that many patients had no detectable signs of cancer 12 months or longer after starting treatment. The results suggest that some patients may be able to avoid chemotherapy, radiation therapy, and surgery, reducing the side effects and long-term complications of these treatments.
The study also found no new safety concerns with dostarlimab.
The global, single-arm AZUR-1 trial enrolled 154 patients who received nine cycles of dostarlimab over six months, with a 500 mg dose every three weeks.
The findings build on an earlier study from Memorial Sloan Kettering Cancer Center, where all 42 patients achieved a complete clinical response with no cancer recurrence during follow-up. Dostarlimab has received FDA Breakthrough Therapy and Fast Track designations for this group of rectal cancer patients.