Summary by Moomoo AI
GSK announced that Jemperli (dostarlimab) has received FDA Breakthrough Therapy Designation for treating locally advanced dMMR/MSI-H rectal cancer. The designation is based on remarkable clinical trial results showing 100% complete response rate in all 42 treated patients, with the first 24 patients maintaining sustained response over a median follow-up of 26.3 months.The breakthrough status aims to expedite development and review of drugs showing substantial improvement over existing therapies. This marks Jemperli's second regulatory designation for this indication, following its Fast Track designation in January 2023. The treatment demonstrated a favorable safety profile with no grade 3 or higher adverse events reported.Current standard treatment for dMMR/MSI-H rectal cancer involves chemotherapy, radiation, and surgery, which can lead to significant quality-of-life impacts including bowel dysfunction and infertility. GSK's ongoing phase II AZUR-1 trial seeks to confirm these promising results, potentially offering a paradigm-shifting treatment option for patients with this condition.
