HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to Be Presented at the Upcoming EHA2024 Congress
HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to Be Presented at the Upcoming EHA2024 Congress
HONG KONG, SHANGHAI and FLORHAM PARK, N.J., May 17, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that topline and subgroup results from the ESLIM-01 Phase III study of sovleplenib, as well as new and updated data related to novel investigational hematological malignancy therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at the upcoming European Hematology Association ("EHA") Hybrid Congress, taking place on June 13-16, 2024 in Madrid, Spain and online.
香港、上海和新泽西州弗洛勒姆公园，2024 年 5 月 17 日（GLOBE NEWSWIRE）— 和黄医药（中国）有限公司（“和黄医药”）（纳斯达克/AIM: HCM；HKEX: 13）今天宣布，索弗莱尼布 ESLIM-01 III 期研究的主要和亚组结果，以及与新型研究性血液学恶性肿瘤 HMPL-306 疗法有关的新数据和更新数据，HMPL-760 和tazemetostat，将在即将于2024年6月13日至16日在西班牙马德里举行的欧洲血液学协会（“EHA”）混合大会上发表，并将在网上举行。
ESLIM-01 is a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in adult patients with primary Immune Thrombocytopenia ("ITP") who have received at least one prior line of standard therapy (NCT05029635). In 188 patients randomized to receive oral sovleplenib or placebo, sovleplenib demonstrated a clinically meaningful early and sustained durable platelet response in patients with primary ITP with durable response rate of 48.4% compared to zero with placebo (p<0.0001). The median time to response was 1.1 weeks with sovleplenib. It demonstrated a tolerable safety profile with grade 3 or above treatment-emergent adverse events (TEAEs) in 25.4% of patients with sovleplenib and 24.2% with placebo. Sovleplenib also significantly improved quality of life in physical functioning and energy/fatigue (p<0.05).
ESLIM-01 是sovleplenib在中国进行的一项随机、双盲、安慰剂对照的III期试验，该试验对象是先前接受过至少一种标准疗法（NCT05029635）的原发性免疫血小板减少症（“ITP”）的成年患者。在随机接受口服sovleplenib或安慰剂的188名患者中，sovleplenib在原发性ITP患者中表现出具有临床意义的早期持续血小板反应，持久缓解率为48.4％，而安慰剂为零（p
Most patients were heavily pretreated with a median of four prior lines of ITP therapy and a majority (71.3%) of the patients had received prior TPO/TPO-RA1 treatment. Further post-hoc subgroup analysis of the study demonstrated consistent clinical benefits across ITP patients regardless of prior lines of ITP therapies or prior TPO/TPO-RA exposure, regardless of TPO/TPO-RA treatment types and number of prior regimens.
大多数患者接受了大量预治疗，中位数为先前四种ITP疗法，而且大多数（71.3％）的患者之前曾接受过TPO/TPO-RA1治疗。对该研究的进一步事后亚组分析表明，无论之前的ITP疗法系列或之前的TPO/TPO-RA暴露如何，无论TPO/TPO-RA治疗类型和先前方案数量如何，ITP患者的临床益处始终如一。
In addition to the promising data in ITP, results from Phase II part of the ongoing ESLIM-02 Phase II/III study (NCT05535933) of sovleplenib for warm antibody autoimmune hemolytic anemia (wAIHA) will also be presented at the congress demonstrating encouraging hemoglobin (Hb) benefit compared with placebo, with overall response rate of 43.8% vs. 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo). A favorable safety profile was also demonstrated.
除了ITP中令人鼓舞的数据外，正在进行的sovleplenib治疗温抗体自身免疫性溶血性贫血（WaiHA）的 ESLIM-02 II/III 期研究（NCT05535933）的第二阶段结果也将在大会上公布，与安慰剂相比，血红蛋白（Hb）的益处令人鼓舞，前8周的总体缓解率为0％，总体缓解率为66.7％ 为期24周的sovleplenib治疗（包括与安慰剂交叉治疗的患者）。还显示了良好的安全性。
Details of the presentations are as follows:
演讲详情如下：
Abstract title |
Presenter / Lead author |
Presentation details |
Efficacy and Safety of The Syk Inhibitor Sovleplenib (HMPL-523) in Adult Patients with Primary Immune Thrombocytopenia in China (ESLIM-01): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study |
Renchi Yang |
#S316 |
Sovleplenib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): Results from the Randomized, Double-Blind, Placebo-Controlled, Phase 2 Part of the Study |
Fengkui Zhang |
#S297 |
Sovleplenib In Primary Immune Thrombocytopenia (ITP) Patients by Prior Lines of Therapy: Subgroup Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (ESLIM-01) |
Xiaofan Liu |
#P1629 |
Sovleplenib In Primary Immune Thrombocytopenia (ITP) Pts with Prior TPO/TPO-RA Treatment: Subgroup Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (ESLIM-01) |
Heng Mei |
#P1631 |
Safety and Efficacy of Syk Inhibitor Sovleplenib in Heavily Pre-Treated Hodgkin Lymphoma Patients |
Paolo Strati |
#P1102 |
HMPL-306 in Patients with Relapsed or Refractory Myeloid Hematological Malignancies Harboring IDH1 and/or IDH2 Mutations: Final Result of Dose Expansion in Phase 1 Study |
Xiaojun Huang |
#P532 |
Phase 1 Study of HMPL-306 in Patients with Advanced Acute Myeloid Leukemia with Isocitrate Dehydrogenase (IDH) Mutations: Preliminary Results of the Dose Escalation Cohorts |
Pau Montesinos |
#P549 |
Phase II Study of EZH2 Inhibitor Tazemetostat plus Amdizalisib, a PI3K Inhibitor, in Patients with Relapsed/Refractory Lymphomas |
Mingci Cai |
#P2080 |
Results from a Phase 1 Dose Escalation Study of HMPL-760, a Third Generation, Highly Selective, Reversible BTK Inhibitor in Chinese Patients with Relapsed/Refractory (R/R) Lymphomas |
Ying Qian |
#P2054 |
A Phase 1b Study to Evaluate the Safety and Preliminary Efficacy of Sovleplenib, a Syk Inhibitor, in Adult Subjects with Immune Thrombocytopenia |
Waleed Ghanima |
#PB3341 |
摘要标题 |
主持人/主要作者 |
演示详情 |
Syk抑制剂Sovleplenib（HMPL-523）对中国成人原发性免疫血小板减少症（ESLIM-01）患者的疗效和安全性：一项随机、双盲、安慰剂对照的3期研究 |
杨仁池 |
#S316 |
用于治疗温抗体自身免疫性溶血性贫血（WaiHA）的Sovleplenib：该研究的随机、双盲、安慰剂对照的第二阶段研究结果 |
张丰奎 |
#S297 |
Sovleplenib 在原发性免疫血小板减少症 (ITP) 患者中的先前疗法：一项多中心、随机、双盲、安慰剂对照的 3 期研究 (ESLIM-01) 的亚组分析 |
刘小凡 |
#P1629 |
Sovleplenib 用于先前接受过TPO/TPO-RA治疗的原发性免疫血小板减少症（ITP）患者：一项多中心、随机、双盲、安慰剂对照的3期研究（ESLIM-01）的亚组分析 |
恒美 |
#P1631 |
Syk抑制剂Sovleplenib在经过大量预处理的霍奇金淋巴瘤患者中的安全性和有效性 |
保罗·斯特拉蒂 |
#P1102 |
包含 IDH1 和/或 IDH2 突变的复发或难治性髓系血液恶性肿瘤患者的 HMPL-306：1 期研究剂量扩大的最终结果 |
黄小军 |
#P532 |
对伴有异柠檬酸脱氢酶 (IDH) 突变的晚期急性髓系白血病患者进行 HMPL-306 的 1 期研究：剂量递增队列的初步结果 |
保罗·蒙特西诺斯 |
#P549 |
EZH2 抑制剂 Tazemetostat 和 PI3K 抑制剂 Amdizalisib 治疗复发/难治性淋巴瘤患者的二期研究 |
蔡明慈 |
#P2080 |
针对中国复发/难治性 (R/R) 淋巴瘤患者的第三代高选择性、可逆性 BTK 抑制剂 HMPL-760 的 1 期剂量递增研究结果 |
钱颖 |
#P2054 |
一项评估Syk抑制剂Sovleplenib对成年免疫血小板减少症受试者的安全性和初步疗效的1b期研究 |
瓦利德·加尼玛 |
#PB3341 |