GSK reports Jemperli rectal cancer trial results

• GSK reported positive interim results from the AZUR-1 Phase II trial of Jemperli in dMMR/MSI-H locally advanced rectal cancer.
• The trial met its primary objective by showing sustained clinical complete responses at 12 months.
• GSK said the results support regulatory discussions for potential use of Jemperli in this patient group.

GSK (NYSE:GSK) reported positive interim results from the Phase II AZUR-1 trial of Jemperli (dostarlimab) in patients with stage II/III mismatch repair deficient or microsatellite instability-high locally advanced rectal cancer, with the study meeting its primary objective.

The results build on earlier research involving Memorial Sloan Kettering Cancer Center and evaluate whether dostarlimab alone could help some patients avoid chemotherapy, radiation and surgery, which are commonly used treatments for this type of cancer.

The AZUR-1 trial enrolled 154 participants who received nine cycles of dostarlimab over six months through 500 mg intravenous infusions every three weeks, with the study assessing sustained clinical complete responses at 12 months.

GSK said the safety and tolerability profile of dostarlimab remained consistent with its established safety profile across solid tumors.

Following the announcement, GSK shares were unchanged at $45.21.

Jemperli is a programmed death receptor-1 (PD-1) blocking antibody that is approved in certain cancer settings and is being studied across gynecologic, colorectal and head and neck cancers.

GSK said it plans to share AZUR-1 interim data with global regulatory authorities to support review, while detailed trial results will be presented at a future scientific congress.