Incyte Announces New Positive Data at EHA 2026 Showed INCA033989 Achieved Rapid, Robust and Sustained Clinical and Molecular Responses and Was Well Tolerated in Patients with Myelofibrosis and Essential Thrombocythemia

Incyte (Nasdaq:INCY) today announced updated clinical data from two Phase 1 studies evaluating the safety, tolerability and efficacy of INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms (MPNs). INCA033989 demonstrated rapid, clinically meaningful responses and consistent molecular activity across both myelofibrosis (MF) and essential thrombocythemia (ET), with convergent evidence supporting the potential for disease modification.

These findings are being presented in oral and poster presentations at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden (Session: Myeloproliferative neoplasms – Clinical, Presentation numbers: S216, PS1983, PF884).

“The data presented at EHA 2026 demonstrate clinically meaningful and consistent responses with INCA033989 across both myelofibrosis and essential thrombocythemia,” said Pablo J. Cagnoni, M.D., President of Incyte and Global Head of Research and Development. “What distinguishes INCA033989 is its potential to deliver disease control while targeting the biology that drives it. We remain on track to initiate our pivotal ET study by mid-2026 and are actively engaging regulators on a pivotal MF program.”

Results in Patients with Myelofibrosis (MF)

The safety, tolerability, and efficacy of INCA033989 in Type 1 and non-Type 1 patients with MF harboring a CALR mutation is being evaluated in two ongoing Phase 1 studies. Results demonstrate that INCA033989 delivers broad, clinically meaningful improvements across spleen volume, symptom burden and anemia in patients with MF. As a monotherapy and in combination with ruxolitinib, INCA033989 had a manageable safety profile and the majority of patients remained on treatment – no dose-limiting toxicities were observed, and a maximum tolerated dose was not reached.

Monotherapy: INCA033989 was evaluated as monotherapy in patients who were resistant, refractory or intolerant to JAK inhibitor treatment after >12 weeks (JAK R/R/I), or ineligible to JAK inhibitor therapy. The dose escalation cohort evaluated INCA033989 from 24-3500 mg, and the dose expansion cohort evaluated 250 mg and 2000 mg.

INCA033989 monotherapy demonstrated durable clinical benefit, with clinically meaningful improvements across spleen volume, symptoms and anemia across both JAK R/R/I and JAK ineligible patients.

• Spleen Volume Reduction (SVR): Rapid and robust spleen volume reductions were observed in patients, with 55% (38/69) and 39% (27/69) of patients achieving the best SVR25 and SVR35 reduction, respectively. At Week 24, 27% (17/62) patients achieved SVR35, including 47% (8/17) JAK ineligible and 20% (9/45) JAK R/R/I. Robust responses were observed in JAK ineligible patients regardless of mutation type (60% [6/10] Type-1 vs. 29% [2/7] non-Type 1). In JAK R/R/I patients, clinically meaningful reductions were observed in 31% (8/26) of Type-1 patients across all evaluated doses at Week 24, and 33% (1/3) of non-Type-1 patients evaluated at 2500 mg, the highest evaluated dose.
• Symptom Improvement: Improvements in symptoms were also observed in the majority of patients, with 53% of patients achieving at least a 50% best TSS reduction (TSS50). At Week 24, 32% of patients achieved TSS50, including 29% and 33% of JAK ineligible and JAK R/R/I patients, respectively.
• Anemia: Rapid and durable anemia improvements were observed in most patients, with anemia response occurring in 60% of evaluable anemic patients, and 52% of patients achieved a major anemia response. Improvements in anemia were observed across patients regardless of prior JAK exposure, including 63% of JAK R/R/I patients and 55% of JAK ineligible patients.
• Molecular: Consistent reductions in variant allele frequency (VAF) were observed across most patients, regardless of prior JAK exposure and mutation type, with 89% of patients achieving a reduction in whole blood mutCALR VAF (Type 1: 90%, Non-Type 1: 88%), and 81% of patients achieving a ≥25% reduction in mutCALR peripheral blood mononuclear cells (PBMC) from baseline (Type 1: 62%, Non-Type 1: 38%).

INCA033989 was generally well-tolerated, with 84% (70/83) of patients remaining on therapy at the time of the data cut off. Treatment emergent adverse events (TEAEs) occurred in 92% (76) of patients, with 27% (22) of patients experiencing Grade ≥3 TEAEs, the most frequent of which were cytopenias. No dose-limiting toxicities were observed, and discontinuations due to TEAEs were limited (n=2).

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