<div id="readability-page-1">Incyte Corporation ( INCY ) on Sunday revealed new clinical data from two Phase 1 studies of INCA033989 for mutCALR-expressing myeloproliferative neoplasms (MPNs) at the 2025 American Society of Hematology (ASH) Annual Meeting. The preliminary analysis (data cut off September 25, 2025) evaluated the safety and efficacy of INCA033989 in myelofibrosis (MF) patients with as measured by spleen volume reduction ≥25% (SVR25) and ≥35% (SVR35), change in MPN-Symptom Assessment Form (SAF), total symptom score (TSS), anemia response and mutCALR variant allele frequency (VAF) reduction. Exploratory analyses from the clinical studies of INCA033989 demonstrate the potential for disease-modifying activity in MF patients with a CALR mutation, the company said in a press release. Also Read: FDA Expands Incyte’s Opzelura Approval To Treat Atopic Dermatitis In Children <h2>Monotherapy Arm of the Trials</h2> In the monotherapy arms, patients treated with INCA033989 experienced rapid and robust spleen and anemia responses and symptom improvements. At Week 24, 41.7% of all evaluable patients achieved SVR25, and 33.3% (12/36) achieved SVR35. Among patients not previously treated with a JAK inhibitor, 71.4% (5/7) achieved SVR25, and 57.1% (4/7) achieved SVR35. Among those resistant or intolerant to JAK inhibitor treatment, 34.5% (10/29) and 27.6% (8/29) achieved SVR25 and SVR35 at Week 24, respectively. Anemia response occurred in more than half (56%; 14/25) of evaluable anemic patients, with 40% (10/25) of patients achieving a major response with INCA033989 treatment. Nearly all patients treated with INCA033989 (93.3%) experienced improved symptoms, with 60% (27/45) achieving a ≥50% reduction in TSS (TSS50) as best response. At Week 24, 39.4% (13/33) of patients achieved a TSS50. Most patients (89.4%; 42/47) with ≥1 post-baseline VAF measurement experienced a reduction in mutCALR VAF, and 10.6% (5/47) achieved a ≥25% best reduction in VAF. Most patients (76.5%) in the studies had co-occurring mutations. Of those, 40.5% of response-eligible patients achieved SVR35 or an anemia response. Single-cell analyses in MF patients with high clonal complexity showed consistent reductions in all CALR-mutant clones, regardless of the presence of co-occurring variants. <h2> Ruxolitinib Combination Arm of the Trials</h2> In the INCA033989 and ruxolitinib combination arms, most MF patients experienced spleen volume reductions and symptom improvements. At Week 24, half (50%; 6/12) of all evaluable MF patients achieved SVR25, and 25% (3/12) achieved SVR35. Among the 14 evaluable patients, 86% had stable anemia, and one patient with non-transfusion dependent anemia had a major anemia response. The majority of patients (81.3%; 13/16) treated with INCA033989 in combination with ruxolitinib experienced symptom improvement, and 33.3% (3/9) achieved TSS50 at Week 24. INCA033989 was well-tolerated, both as a monotherapy and in combination with ruxolitinib In addition to myelofibrosis (MF), INCA033989 is also being evaluated in Phase 1 studies for the treatment of patients with essential thrombocythemia (ET). The company plans to initiate a registrational program evaluating INCA033989 for ET patients harboring a Type 1 or non-Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy in 2026. INCY Price Action: Incyte ( INCY ) shares were down 2.46% at $99.99 during premarket trading on Monday, according to Benzinga Pro data. Read Next: <ul> <li>Southwest Airlines Gets $11 Million Fine Waiver By Trump Administration Over 2022 Holiday Travel Crisis</li> </ul> Photo via Shutterstock</div>

因塞特医疗

Incyte Corporation 在 2025 年美国血液学会年会上公布了关于 INCA033989 在突变 CALR 表达的骨髓增生性肿瘤的第一阶段研究的新临床数据。研究显示该药物在携带 CALR 突变的 MF 患者中具有潜在的疾病修饰活性，表现为脾脏体积显著缩小、贫血反应和症状改善。INCA033989 在单药治疗和与 ruxolitinib 联合使用时均耐受良好。Incyte 计划在 2026 年为携带 CALR 突变的 ET 患者开展注册程序。在盘前交易中，Incyte 的股价下跌了 2.46%，报 99.99 美元

因塞特医疗的新疗法在罕见血液癌症中展现出 “改变疾病” 潜力的迹象