GSK reported positive interim results from the phase II AZUR-1 trial of Jemperli (dostarlimab) in stage II/III dMMR/MSI-H locally advanced rectal cancer.
- The single-arm study met its primary endpoint, showing a sustained clinical complete response rate at 12 months.
- The results support the potential use of dostarlimab to eliminate or delay chemotherapy, radiation or surgery in some patients if cleared by regulators.
- Dostarlimab received FDA Breakthrough Therapy and Fast Track designations in this setting, and GSK plans to submit interim data to regulators.
- The safety profile in the interim analysis was consistent with prior experience across solid tumors.
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