Incyte announces new data for INCA033989 from Phase 1 study

Incyte (INCY) announced new clinical data from two Phase 1 studies evaluating the safety, tolerability and efficacy of INCA033989, a first-in-class mutant calreticulin-targeted monoclonal antibody, for patients with mutCALR-expressing myeloproliferative neoplasms. These preliminary results are from the dose escalation portion of the studies evaluating INCA033989 as a monotherapy in patients with myelofibrosis harboring a CALR mutation who are resistant, intolerant to or ineligible for JAK inhibitor treatment, and INCA033989 in combination with ruxolitinib in patients who experienced a suboptimal response to ruxolitinib monotherapy. Key points: Rapid and robust reductions in spleen volume and symptoms, and improvements in anemia were observed with INCA033989 as monotherapy and in combination with ruxolitinib in patients with myelofibrosis harboring a CALR mutation; Results 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; A reduction in peripheral blood mutCALR variant allele frequency from baseline was observed in MF patients in the INCA033989 monotherapy arm with greater than or equal to1 post-baseline VAF measurement; Exploratory analyses from the clinical studies of INCA033989 demonstrate the potential for disease-modifying activity in MF patients with a CALR mutation