GSK has reported a main-goal win in a pivotal Phase 2 rectal cancer study and is now positioning Jemperli for an FDA submission under an accelerated pathway. In the AZUR-1 trial, the PD-1 inhibitor met its primary endpoint 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 said it plans to share results with global regulators and pursue FDA review speed via a prior voucher. Standard of care in this setting typically includes chemotherapy, radiation and surgery, so GSK framed the response durability as potential evidence that some patients could avoid those interventions while remaining free of detectable disease. In parallel, GSK disclosed that FDA oncologic advisory committee experts voted 8 to 5 in support of the regulatory path based on complete response data from a single-arm design. The U.S. incidence of rectal cancer and the small fraction of cases with dMMR/MSI-H were cited as context for the trial scope and submission strategy.