Lilly's First Type II JAK2 Inhibitor Phase 1 Study Shows 70% of Patients Achieve Spleen Reduction
2026-06-15 17:00
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en.Wedoany.com Reported - Eli Lilly and Company (Lilly) has announced the first clinical data for its investigational drug AJ1-11095, showing that this oral type II selective JAK2 inhibitor produced a high response rate in patients with previously treated myelofibrosis: 70% of patients achieved a best response of spleen volume reduction of 35% or greater (SVR35), and at week 12, 70% of patients experienced a 50% or greater improvement in symptom burden (TSS50). These data will be presented as an oral presentation at the 2026 European Hematology Association (EHA) Annual Meeting, abstract number S218.

AJ1-11095 is a first-in-class drug designed to bind to the inactive conformation of JAK2. Lilly acquired the program following its acquisition of Ajax Therapeutics. The study is the Phase 1 AJX-101 trial, which enrolled 23 patients with primary or secondary myelofibrosis in the dose-escalation phase, who had received a median of 2 prior therapies and had all previously used type I JAK2 inhibitors. The study evaluated five once-daily dose levels: 25, 50, 75, 100, and 125 mg.

As of the data cutoff date of May 28, 2026, 21 of 23 patients showed a decrease in variant allele frequency (VAF) of driver mutations; as of May 12, 2026, among 17 patients at week 24, 59% had a VAF decrease of 20% or greater for JAK2, MPL, and CALR mutations, and 35% had a decrease of 50% or greater. In terms of safety, the overall profile was generally manageable, with no dose-limiting toxicities observed, and 78% of patients in the dose-escalation phase remained on study treatment. Common treatment-emergent adverse events included anemia, dysgeusia, decreased platelet count, and elevated alanine aminotransferase. AJ1-11095 is currently being evaluated in an expansion cohort in patients with second-line myelofibrosis, and studies are planned in high-risk polycythemia vera and treatment-naïve myelofibrosis (NCT06343805).

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