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.
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).
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.
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.
Details of the presentations are as follows:
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
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China | #S316
Oral Presentation (Platelet disorders in the spotlight: Clinical and translational)
Friday, June 14, 2024
15:00 – 15:15 CEST, Hall Mallo |
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
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China | #S297
Oral Presentation (Thalassemias and rare anemias)
Sunday, June 16, 2024
12:00 – 12:15 CEST, Hall Mallo |
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
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China | #P1629
Poster Session
Friday, June 14, 2024 |
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China | #P1631
Poster Session
Friday, June 14, 2024 |
Safety and Efficacy of Syk Inhibitor Sovleplenib in Heavily Pre-Treated Hodgkin Lymphoma Patients | Paolo Strati
The University of Texas MD Anderson Cancer Center, Houston, U.S. | #P1102
Poster Session
Friday, June 14, 2024 |
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
Peking University People's Hospital, Beijing, China | #P532
Poster Session
Friday, June 14, 2024 |
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
Hospital Universitario La Fe, Valencia, Spain | #P549
Poster Session
Friday, June 14, 2024 |
Phase II Study of EZH2 Inhibitor Tazemetostat plus Amdizalisib, a PI3K Inhibitor, in Patients with Relapsed/Refractory Lymphomas | Mingci Cai
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China | #P2080
e-Poster Presentation
Friday, June 14, 2024 |
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
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China | #P2054
e-Poster Presentation
Friday, June 14, 2024 |
A Phase 1b Study to Evaluate the Safety and Preliminary Efficacy of Sovleplenib, a Syk Inhibitor, in Adult Subjects with Immune Thrombocytopenia | Waleed Ghanima
University of Oslo, Oslo, Norway | #PB3341
Publication Only |
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 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<0.0001）。使用sovleplenib的中位緩解時間爲1.1周。在25.4％的sovleplenib患者和24.2％的安慰劑患者中，其3級或以上的治療緊急不良事件（TEAE）表現出可耐受的安全性。Sovleplenib還顯著改善了身體機能和能量/疲勞方面的生活質量（p<0.05）。
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。
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。
演講詳情如下：
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
中國醫學科學院血液與血液病醫院研究所，中國天津 | #S316
口頭陳述（聚光燈下的血小板疾病：臨床和轉化）
2024 年 6 月 14 日，星期五
15:00 — 15:15 CEST，Hall Mallo |
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
中國醫學科學院血液與血液病醫院研究所，中國天津 | #S297
口頭報告（地中海貧血和罕見貧血）
2024 年 6 月 16 日，星期日
12:00 — 12:15 CEST，Hall Mallo |
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
中國醫學科學院血液與血液病醫院研究所，中國天津 | #P1629
海報發佈會
2024 年 6 月 14 日，星期五 |
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
中國武漢華中科技大學同濟醫學院協和醫院 | #P1631
海報發佈會
2024 年 6 月 14 日，星期五 |
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
美國休斯敦德克薩斯大學醫學博士安德森癌症中心 | #P1102
海報發佈會
2024 年 6 月 14 日，星期五 |
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
中國北京大學人民醫院 | #P532
海報發佈會
2024 年 6 月 14 日，星期五 |
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
西班牙瓦倫西亞拉菲大學醫院 | #P549
海報發佈會
2024 年 6 月 14 日，星期五 |
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
上海交通大學醫學院附屬瑞金醫院，中國上海 | #P2080
電子海報演示
2024 年 6 月 14 日，星期五 |
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
上海交通大學醫學院附屬瑞金醫院，中國上海 | #P2054
電子海報演示
2024 年 6 月 14 日，星期五 |
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
奧斯陸大學，奧斯陸，挪威 | #PB3341
僅限出版 |
