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、上海和新澤西州弗洛勒姆公園，2024 年 5 月 17 日（GLOBE NEWSWIRE）— 和黃醫藥（中國）有限公司（“和黃醫藥”）（納斯達克/AIM: HCM；HKEX: 13）今天宣佈，索弗萊尼布 ESLIM-01 III 期研究的主要和亞組結果，以及與新型研究性血液學惡性腫瘤 HMPL-306 療法有關的新數據和更新數據，HMPL-760 和tazemetostat，將在即將於2024年6月13日至16日在西班牙馬德里舉行的歐洲血液學協會（“EHA”）混合大會上發表，並將在網上舉行。
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在中國進行的一項隨機、雙盲、安慰劑對照的III期試驗，該試驗對象是先前接受過至少一種標準療法（NCT05029635）的原發性免疫血小板減少症（“ITP”）的成年患者。在隨機接受口服sovleplenib或安慰劑的188名患者中，sovleplenib在原發性ITP患者中表現出具有臨床意義的早期持續血小板反應，持久緩解率爲48.4％，而安慰劑爲零（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.
大多數患者接受了大量預治療，中位數爲先前四種ITP療法，而且大多數（71.3％）的患者之前曾接受過TPO/TPO-RA1治療。對該研究的進一步事後亞組分析表明，無論之前的ITP療法系列或之前的TPO/TPO-RA暴露如何，無論TPO/TPO-RA治療類型和先前方案數量如何，ITP患者的臨床益處始終如一。
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中令人鼓舞的數據外，正在進行的sovleplenib治療溫抗體自身免疫性溶血性貧血（WaiHA）的 ESLIM-02 II/III 期研究（NCT05535933）的第二階段結果也將在大會上公佈，與安慰劑相比，血紅蛋白（Hb）的益處令人鼓舞，前8周的總體緩解率爲0％，總體緩解率爲66.7％ 爲期24周的sovleplenib治療（包括與安慰劑交叉治療的患者）。還顯示了良好的安全性。
Details of the presentations are as follows:
演講詳情如下：
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 |
摘要標題 |
主持人/主要作者 |
演示詳情 |
Syk抑制劑Sovleplenib（HMPL-523）對中國成人原發性免疫血小板減少症（ESLIM-01）患者的療效和安全性：一項隨機、雙盲、安慰劑對照的3期研究 |
楊仁池 |
#S316 |
用於治療溫抗體自身免疫性溶血性貧血（WaiHA）的Sovleplenib：該研究的隨機、雙盲、安慰劑對照的第二階段研究結果 |
張豐奎 |
#S297 |
Sovleplenib 在原發性免疫血小板減少症 (ITP) 患者中的先前療法：一項多中心、隨機、雙盲、安慰劑對照的 3 期研究 (ESLIM-01) 的亞組分析 |
劉小凡 |
#P1629 |
Sovleplenib 用於先前接受過TPO/TPO-RA治療的原發性免疫血小板減少症（ITP）患者：一項多中心、隨機、雙盲、安慰劑對照的3期研究（ESLIM-01）的亞組分析 |
恒美 |
#P1631 |
Syk抑制劑Sovleplenib在經過大量預處理的霍奇金淋巴瘤患者中的安全性和有效性 |
保羅·斯特拉蒂 |
#P1102 |
包含 IDH1 和/或 IDH2 突變的復發或難治性髓系血液惡性腫瘤患者的 HMPL-306：1 期研究劑量擴大的最終結果 |
黃小軍 |
#P532 |
對伴有異檸檬酸脫氫酶 (IDH) 突變的晚期急性髓系白血病患者進行 HMPL-306 的 1 期研究：劑量遞增隊列的初步結果 |
保羅·蒙特西諾斯 |
#P549 |
EZH2 抑制劑 Tazemetostat 和 PI3K 抑制劑 Amdizalisib 治療復發/難治性淋巴瘤患者的二期研究 |
蔡明慈 |
#P2080 |
針對中國復發/難治性 (R/R) 淋巴瘤患者的第三代高選擇性、可逆性 BTK 抑制劑 HMPL-760 的 1 期劑量遞增研究結果 |
錢穎 |
#P2054 |
一項評估Syk抑制劑Sovleplenib對成年免疫血小板減少症受試者的安全性和初步療效的1b期研究 |
瓦利德·加尼瑪 |
#PB3341 |