Press release
Incyte Presents Updated Positive Data at ASH 2025 Reinforcing the Potential of INCA033989, its First-in-Class mutCALR-Targeted Monoclonal Antibody, in Patients with Essential Thrombocythemia
Nearly all (90%) of essential thrombocythemia (ET) patients treated with INCA033989 at the higher dose achieved a hematologic response (HR) with 83.3%
About this update from Incyte Corporation
[{"type":"text","content":"\n\nNearly all (90%) of essential thrombocythemia (ET) patients treated with INCA033989 at the higher dose achieved a hematologic response (HR) with 83.3% achieving a complete HR\n\n\n\nMolecular responses were frequent, rapid, durable and correlated with hematologic responses; a reduction in mutCALR variant allele frequency (VAF) from baseline occurred in 96.2% of patients with ≥1 post-baseline VAF measurement\n\n\n\nExploratory analyses from the clinical studies show potential direct disease-modifying activity of INCA033989\n\n\n\nResults demonstrate a favorable safety profile – no dose limiting toxicities were reported and a maximum tolerated dose was not reached\n\n\n\nThe FDA granted Breakthrough Therapy designation to INCA033989 for the treatment of patients with ET harboring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (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, as a treatment for patients with mutCALR-expressing myeloproliferative neoplasms (MPNs). These data, which are featured in oral presentations at the 2025 American Society of Hematology (ASH) Annual Meeting in Orlando (Session 634, Publication #1024; Session 631, Publication #71), focus on the dose escalation portion of the studies in patients with essential thrombocythemia (ET) harboring a CALR mutation who are resistant or intolerant to at least one cytoreductive therapy.\n\n“The compelling efficacy and safety data presented today at the 2025 ASH Annual Meeting provide additional evidence of the potential for INCA033989 to provide disease modification for high-risk ET patients harboring a CALR mutation,” said Pablo J. Cagnoni, M.D., President, Head of Research and Development, Incyte. “We are proud to be advancing a portfolio of novel targeted therapies, including INCA033989, that could offer a mutation-specific treatment for patients with mutCALR-expressing MPNs.”\n\nResults presented today evaluate the safety and efficacy of INCA033989 in patients with ET, as measured by hematologic response and reduction in mutCALR variant allele frequency (VAF), and build upon previously announced data presen...