GSK moved closer to an FDA filing for Jemperli after AZUR-1 Phase 2 results in a small but high-stakes rectal cancer subgroup. The company said Jemperli (pd-1 inhibitor) met the main goal, with a “meaningful and sustained” clinical complete response rate at 12 months in stage 2/3 dMMR/MSI-H locally advanced rectal cancer. GSK said it plans to submit to regulators and share data with global health authorities, including the FDA, under an accelerated approval pathway supported by prior single-arm complete-response data and an FDA oncologic advisory committee vote in favor of the approach. The trial outcome was positioned as potential evidence that some patients may avoid chemotherapy, radiation, and surgery while remaining free of detectable cancer. The move keeps pressure on the limited treatment options in locally advanced dMMR/MSI-H rectal cancer, where care is typically defined by aggressive multimodality intervention and associated long-term quality-of-life impacts.