GSK says Jemperli hits sustained complete response endpoint in phase II rectal cancer trial

• 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.
• Single-arm study met its primary endpoint, showing a sustained clinical complete response rate at 12 months.
• Results support 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; GSK plans to submit interim data to regulators.
• Safety profile in interim analysis was consistent with prior experience across solid tumors.

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