<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>

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Incyte Corporation 在 2025 年美國血液學會年會上公佈了關於 INCA033989 在突變 CALR 表達的骨髓增生性腫瘤的第一階段研究的新臨牀數據。研究顯示該藥物在攜帶 CALR 突變的 MF 患者中具有潛在的疾病修飾活性，表現為脾臟體積顯著縮小、貧血反應和症狀改善。INCA033989 在單藥治療和與 ruxolitinib 聯合使用時均耐受良好。Incyte 計劃在 2026 年為攜帶 CALR 突變的 ET 患者開展註冊程序。在盤前交易中，Incyte 的股價下跌了 2.46%，報 99.99 美元

因塞特醫療的新療法在罕見血液癌症中展現出 “改變疾病” 潛力的跡象