GSK is moving toward an FDA filing after Jemperli (dostarlimab) met its primary goal in a pivotal Phase 2 study in stage 2/3 dMMR/MSI-H locally advanced rectal cancer, with GSK describing a meaningful and sustained clinical complete response rate at 12 months. The company’s broader strategy hinges on converting that signal into a regulatory submission for a small but high-stakes population. In the AZUR-1 program, GSK said its PD-1 inhibitor delivered “substantial improvement” versus historical experience, and it plans to share data with regulators including the FDA under an accelerated approval pathway. GSK also highlighted the potential for some patients to avoid chemotherapy, radiation, and surgery. A separate report notes that Jemperli received a voucher to speed review under a new FDA pilot program, underscoring the intent to accelerate timelines. The move places GSK’s rectal cancer data directly into the near-term regulatory decision track.