Shots:
- The US FDA has accepted the sBLA under Project Orbis & granted priority review to Jemperli in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (PDUFA: Feb 2027), with eligibility for an earlier decision through the NPV program
- sBLA was based on the global P-II (AZUR-1) trial assessing Jemperli (dostarlimab) monotx. (500mg, IV, Q3W for 9 cycles) in 154 pts with stage II/III dMMR/MSI-H locally advanced rectal cancer
- Trial met its 1EP, with a meaningful & sustained clinical complete response rate at 12mos., with no detectable signs of cancer for ≥1yr. data will be submitted for a presentation at a future congress later in 2026
Ref: GSK | Image: GSK | Press Release
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