Press release
Incyte Announces New Positive Data for INCA033989, its First-In-Class mutCALR-Targeted Monoclonal Antibody, in Patients with Myelofibrosis Presented at ASH 2025
Rapid and robust reductions in spleen volume and symptoms, and improvements in anemia were observed with INCA033989 as monotherapy and in combination with
About this update from Incyte Corporation
[{"type":"text","content":"\n\nRapid and robust reductions in spleen volume and symptoms, and improvements in anemia were observed with INCA033989 as monotherapy and in combination with ruxolitinib (Jakafi®) in patients with myelofibrosis (MF) harboring a CALR mutation (mutCALR)\n\n\nResults demonstrate a favorable safety profile for INCA033989 as a monotherapy and in combination with ruxolitinib – no dose limiting toxicities were reported and a maximum tolerated dose was not reached\n\n\nA reduction in peripheral blood mutCALR variant allele frequency (VAF) from baseline was observed in MF patients in the INCA033989 monotherapy arm with ≥1 post-baseline VAF measurement\n\n\nExploratory analyses from the clinical studies of INCA033989 demonstrate the potential for disease-modifying activity in MF patients with a CALR mutation\n\n\nIncyte will host an investor event and webcast highlighting these data today, Sunday, December 7, 2025, from 11:00 a.m.-12:30 p.m. ET\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced new 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, for patients with mutCALR-expressing myeloproliferative neoplasms (MPNs). These preliminary results are from the dose escalation portion of the studies evaluating INCA033989 as a monotherapy in patients with myelofibrosis (MF) harboring a CALR mutation who are resistant, intolerant to or ineligible for JAK inhibitor treatment, and INCA033989 in combination with ruxolitinib (Jakafi®) in patients who experienced a suboptimal response to ruxolitinib monotherapy. These data are being featured in oral presentations (Session 634, Publication #484; Session 631, Publication #71) at the 2025 American Society of Hematology (ASH) Annual Meeting in Orlando.\n\n“These positive study results reinforce our confidence in INCA033989’s transformative potential, both as a targeted monotherapy and combination therapy for MF, building on the positive results previously reported in essential thrombocythemia (ET),” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “Our goal is to bring new targeted treatment options to patients across the MPN disease spectrum. In line with this commitment, we plan to initiate a registrational ...