GSK said Jemperli (dostarlimab) met the primary goal in an AZUR-1 phase 2 study in dMMR/MSI-H locally advanced rectal cancer, setting up an FDA submission with the company targeting an accelerated approval route based on clinical complete response rates at 12 months. GSK characterized the responses as “meaningful and sustained,” positioning the PD-1 inhibitor as a potential way to reduce reliance on chemoradiation and surgery in a smaller but high-attention niche. Separately, CSPI’s “one pivotal trial” critique underscores the evidentiary debate shaping late-stage oncology submissions and label expectations, particularly where single-arm or single-trial designs are under consideration for regulatory pathways.