Shots:
- Kyverna has reported P-II (KYSA-8) trial data assessing a single dose of mivocabtagene autoleucel (miv-cel; KYV-101) in 26 SPS pts having an inadequate response with non-approved treatment options
- Trial met its 1EP with 46% median improvement in T25FW & 81% pts achieving a clinically meaningful ≥20% gain, plus significant benefits were seen across all 2EPs, incl. mRS, DSI, HAI & HSS. Of the 12 pts who required a walking aid device, 67% no longer needed assistance, while 100% remained immunotherapy-free with no rescue therapy required
- Kyverna is planning to submit BLA to the FDA in H1’26 based on these data, with full SPS data to be shared in a medical meeting in 2026
Ref: Kyverna| Image: Kyverna | Press Release
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