Incyte announces data from two studies evaluating INCA033989
Incyte (INCY) announced the first clinical data from two studies evaluating the safety, tolerability and efficacy of INCA033989, a novel, first in class, Incyte-discovered, targeted monoclonal antibody in patients with mutant calreticulin-expressing myeloproliferative neoplasms, MPNs. These data – featured today in the Late-Breaking Oral Session at the European Hematology Association 2025, EHA 2025, Congress in Milan, Italy – focus on the dose escalation portion of the studies in patients with high risk essential thrombocythemia who are resistant/intolerant to prior cytoreductive therapy. The studies evaluated the safety and efficacy of INCA033989 in patients with ET as measured by hematologic response and reduction in mutCALR variant allele frequency. Results as of April 4, 2025, showed rapid and durable normalization of platelet counts across all dose levels, with a trend toward improved responses in higher doses, in patients with ET treated with INCA033989. Notably, 86% of patients at doses 400 mg and above achieved a complete or partial hematologic response, with the majority of patients achieving complete response. Eighty-nine percent of evaluable patients showed a reduction in mutCALR VAF from baseline. A partial molecular response was observed in 21% of evaluable patients after only 3 cycles of treatment.
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