Jemperli delivers lasting clinical complete responses in dMMR/MSI-H locally advanced rectal cancer

GSK has released positive interim findings from the registrational Phase II AZUR-1 trial of Jemperli in patients with stage II/III mismatch repair deficient, microsatellite instability-high locally advanced rectal cancer. The single-arm trial cleared its primary objective, demonstrating a meaningful and sustained rate of clinical complete response at twelve months.

The data raise the possibility that dostarlimab, if approved, could become the first immunotherapy with the potential to remove or defer the need for chemotherapy, radiation, and surgery in some patients within this population.

Rectal cancer, a form of bowel cancer, touches around 730,000 people globally each year, with the dMMR/MSI-H subtype accounting for roughly 5 to 10% of all rectal cancer cases. Standard treatment typically involves chemotherapy, radiation, and surgery, approaches that, while frequently effective, can leave a lasting mark on quality of life, potentially including lifelong reliance on a colostomy bag, significant physiological complications, and loss of fertility.

“The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data demonstrate that some patients may be able to avoid those interventions while remaining free of detectable signs of cancer,” said Hesham Abdullah, Senior Vice President and Global Head of Oncology Research and Development, GSK.

The AZUR-1 findings represent a notable step forward compared to what the historical standard of care has delivered, and extend a body of earlier research carried out in collaboration with Memorial Sloan Kettering Cancer Center, which first pointed to the potential of dostarlimab to achieve clinical complete responses without additional interventions in this patient group.

Safety and tolerability data from the interim analysis remained consistent with dostarlimab’s well-characterised and manageable profile as seen across solid tumours more broadly.

Dostarlimab holds both Breakthrough Therapy and Fast Track designations from the US Food and Drug Administration in this setting. GSK intends to share the interim AZUR-1 results with regulatory authorities worldwide to support formal review, with full data to be presented at a forthcoming scientific congress.

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Related Topics and Keywords

dMMR/MSI-H locally advanced rectal cancer, JEMPERLI, rectal cancer