GSK said its PD-1 antibody Jemperli met the main goal in the pivotal Phase 2 AZUR-1 study in stage 2/3 dMMR/MSI-H locally advanced rectal cancer, setting up an FDA filing. The company reported a “meaningful and sustained” clinical complete response rate at 12 months and said it plans to share data with regulators, including under an accelerated approval pathway. GSK framed the result as a potential shift away from standard chemoradiotherapy and surgery for some patients, where current care can entail major quality-of-life impacts. The company said the regulatory strategy is based on complete response data in the single-arm study. GSK is also leaning into prior momentum: investigators previously reported complete remissions in a small Memorial Sloan Kettering study, and GSK said an FDA advisory committee supported the accelerated path for this biomarker-defined population. The indication is relatively small, with GSK citing an estimated 50,000 rectal cancer cases in the U.S. for 2026 and dMMR/MSI-H present in roughly 5% to 10% of rectal tumors.