Kyverna Therapeutics (KYTX) announced positive longer-term follow-up data from the Phase 2 portion of its registrational KYSA-6 trial of miv-cel in patients with generalized myasthenia gravis. The data will be presented today during an oral presentation at the American Academy of Neurology Annual Meeting in Chicago. The updated data demonstrate deep and durable clinical responses across all key clinical outcome measures with sustained benefit observed out to one year following a single dose of miv-cel. Further, miv-cel was well-tolerated. Efficacy highlights from the updated Phase 2 trial following a single dose of miv-cel are as follows: 100% of patients achieved clinically sustained reductions in MG-ADL and QMG scores from baseline, regardless of prior biologic exposure and at deeper levels observed compared to prior interim analysis. 100% of patients were free of nonsteroidal immunosuppressants, high-dose steroids (greater than10mg), and FcRn and complement inhibitors through Week 24. Additionally, Miv-cel demonstrated a well-tolerated safety profile supporting the potential for outpatient administration
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