HUTCHMED Highlights Clinical Data to be Presented at the 2024 ASH Annual Meeting and the 2024 ESMO Asia Congress
HUTCHMED announced new data presentations at the 2024 ASH Annual Meeting and ESMO Asia Congress. The key highlight is the long-term safety and efficacy data from the ESLIM-01 Phase III study of sovleplenib in adult patients with chronic primary immune thrombocytopenia (ITP) in China. The study showed that 81% of patients achieved overall response, with durable response rates of 51.4% and long-term durable response of 59.8%. Among 179 treated patients, 55.3% remained on treatment with a median exposure of 56.6 weeks. The treatment demonstrated effectiveness in maintaining platelet counts and showed a favorable safety profile consistent with previous studies.
HUTCHMED ha annunciato nuove presentazioni di dati per il Meeting Annuale ASH 2024 e il Congresso ESMO Asia. Il punto saliente è rappresentato dai dati sulla sicurezza e l'efficacia a lungo termine dello studio di fase III ESLIM-01 su sovleplenib in pazienti adulti con trombocitopenia immune cronica primaria (ITP) in Cina. Lo studio ha dimostrato che l'81% dei pazienti ha raggiunto una risposta complessiva, con tassi di risposta duraturi del 51,4% e una risposta duratura a lungo termine del 59,8%. Tra i 179 pazienti trattati, il 55,3% è rimasto in trattamento con un'esposizione mediana di 56,6 settimane. Il trattamento ha dimostrato efficacia nel mantenere i livelli di piastrine e ha mostrato un profilo di sicurezza favorevole, coerente con studi precedenti.
HUTCHMED anunció nuevas presentaciones de datos en la Reunión Anual ASH 2024 y el Congreso ESMO Asia. El punto clave son los datos de seguridad y eficacia a largo plazo del estudio de fase III ESLIM-01 de sovleplenib en pacientes adultos con trombocitopenia inmune primaria crónica (ITP) en China. El estudio mostró que el 81% de los pacientes alcanzó una respuesta general, con tasas de respuesta duradera del 51,4% y una respuesta duradera a largo plazo del 59,8%. Entre los 179 pacientes tratados, el 55,3% continuó en tratamiento con una exposición mediana de 56,6 semanas. El tratamiento demostró efectividad en el mantenimiento de los recuentos plaquetarios y mostró un perfil de seguridad favorable, consistente con estudios previos.
HUTCHMED는 2024년 ASH 연례 회의 및 ESMO 아시아 회의에서 새로운 데이터 발표를 발표했습니다. 주요 하이라이트는 중국에서 만성 원발성 면역 혈소판 감소증(ITP) 성인 환자에 대한 sovleplenib의 ESLIM-01 3상 연구의 장기 안전성과 효능 데이터입니다. 연구 결과, 81%의 환자가 전반적인 반응을 보였고, 지속적인 반응 비율은 51.4%, 장기 지속 반응율은 59.8%로 나타났습니다. 179명의 치료받은 환자 중 55.3%는 56.6주 평균 노출로 치료를 계속 받았습니다. 이 치료는 혈소판 수치를 유지하는 데 효과적이며 이전 연구와 일치하는 유리한 안전성 프로필을 보여주었습니다.
HUTCHMED a annoncé de nouvelles présentations de données lors de la Réunion Annuelle ASH 2024 et du Congrès ESMO Asie. Le point fort concerne les données de sécurité et d'efficacité à long terme de l'étude de phase III ESLIM-01 sur sovleplenib chez des patients adultes atteints de thrombocytopénie immune primaire chronique (ITP) en Chine. L'étude a révélé que 81 % des patients ont atteint une réponse globale, avec des taux de réponse durable de 51,4 % et une réponse durable à long terme de 59,8 %. Parmi les 179 patients traités, 55,3 % sont restés sous traitement avec une exposition médiane de 56,6 semaines. Le traitement a démontré son efficacité dans le maintien des niveaux de plaquettes et a présenté un profil de sécurité favorable, cohérent avec des études précédentes.
HUTCHMED hat neue Datenpräsentationen auf dem 2024 ASH-Jahrestreffen und dem ESMO-Asienkongress angekündigt. Das Hauptaugenmerk liegt auf den langfristigen Sicherheits- und Wirksamkeitsdaten der ESLIM-01-Phase-III-Studie zu sovleplenib bei erwachsenen Patienten mit chronischer primärer immuner Thrombozytopenie (ITP) in China. Die Studie zeigte, dass 81 % der Patienten eine Gesamtansprache erreichten, mit einer nachhaltigen Antwortquote von 51,4 % und einer langfristigen nachhaltigen Antwort von 59,8 %. Von 179 behandelten Patienten blieben 55,3 % mit einer medianen Expositionszeit von 56,6 Wochen in der Behandlung. Die Behandlung erwies sich als wirksam bei der Aufrechterhaltung der Thrombozytenzahlen und wies ein günstiges Sicherheitsprofil auf, das mit früheren Studien übereinstimmt.
- 81% overall response rate in Phase III ESLIM-01 trial
- 59.8% long-term durable response rate
- 55.3% patient retention rate in treatment
- Favorable safety profile with no new safety signals
- None.
Insights
The presented data from the ESLIM-01 Phase III trial shows promising long-term efficacy and safety results for sovleplenib in treating chronic primary immune thrombocytopenia. Key findings include:
- An impressive
81% overall response rate among 179 patients 55.3% of patients remained on treatment with a median exposure of 56.6 weeks- Durable response rate of
51.4% with long-term durability at59.8%
While these clinical results are encouraging, the conference presentations are preliminary announcements without immediate revenue implications. The multiple investigator-initiated studies across various cancers, particularly for fruquintinib, demonstrate strong research momentum but don't represent material near-term catalysts for investors.
HONG KONG, SHANGHAI, and FLORHAM PARK, N.J., Nov. 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from the sovleplenib ESLIM-01 Phase III trial, as well as several investigator-initiated studies of compounds discovered by HUTCHMED will be presented at the American Society of Hematology (“ASH”) Annual Meeting taking place on December 7-10, 2024 in San Diego, USA, and the European Society for Medical Oncology (“ESMO”) Asia Congress 2024, taking place on December 6-8, 2024 in Singapore.
Long-term safety and efficacy data from a follow-on, open-label sub-study of the extension stage of ESLIM-01 Phase III study of sovleplenib in adult patients with chronic primary immune thrombocytopenia (“ITP”) in China will be reported at the 2024 ASH Annual Meeting (NCT05029635). At data cut-off on January 31, 2024, a total of 179 patients were treated with at least one dose of sovleplenib.
The follow-on sub-study data demonstrated that long-term treatment with sovleplenib was effective in increasing and maintaining platelet count in adults with chronic primary ITP in China. In the overall population, the overall response was achieved by
| Abstract title | Presenter / Lead author | Presentation details |
2024 ASH ANNUAL MEETING – SPONSORED STUDY | ||
| Long-Term Sovleplenib Treatment of Adults with Primary Immune Thrombocytopenia in China | Yu Hu Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China | #2558 Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster II Sunday, December 8, 2024 6:00 PM - 8:00 PM Pacific Time |
| ESMO ASIA CONGRESS 2024 – INVESTIGATOR-INITIATED STUDIES | ||
| Efficacy and safety of fruquintinib combined with serplulimab as 1st line treatment in advanced non-clear cell renal cell carcinoma (nccRCC): A single-arm, multicentre clinical trial | Wei Xue, Jiwei Huang Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China | #274MO Mini Oral session: Genitourinary tumours Sunday, December 8, 2024 9:42 - 9:47 AM Singapore Time |
| Stereotactic body radiation therapy followed by fruquintinib in combination with immunotherapy as third- and later-line treatment in metastatic colorectal cancer | Chen Zhang, Yi Wang Ningbo No.2 Hospital, Ningbo, China | #81P Poster Display: Gastrointestinal tumours, colorectal Saturday, December 7, 2024 |
| Results from FRONT study: A multicenter, randomized, open-label clinical trial of fruquintinib as maintenance therapy after 1L treatment in metastatic colorectal cancer (mCRC) | Tianshu Liu, Xiaojing Xu Zhongshan Hospital Affiliated to Fudan University, Shanghai, China | #82P Poster Display: Gastrointestinal tumours, colorectal Saturday, December 7, 2024 |
| Fruquintinib in combination with S-1 for ESCC patients after first-line immunotherapy failure: Update of dose-finding results | Lin Zhao, Ningning Li Peking Union Medical College Hospital, Beijing, China | #194P Poster Display: Gastrointestinal tumours, colorectal Saturday, December 7, 2024 |
| Efficacy and safety of concurrent bevacizumab in combination with standard radiotherapy and temozolomide followed by bevacizumab in combination with temozolomide and surufatinib in glioblastoma: A phase 2 clinical trial | Rongjie Tao, Hui Zhang Shandong Cancer Hospital Affiliated to Shandong University, Jinan, China | #766P Poster Display: General interest Saturday, December 7, 2024 |
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, savolitinib, sovleplenib and surufatinib, the further clinical development for fruquintinib, savolitinib, sovleplenib and surufatinib, its expectations as to whether any studies on fruquintinib, savolitinib, sovleplenib and surufatinib, would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, savolitinib, sovleplenib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, savolitinib, sovleplenib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of serplulimab, sintilimab, S-1, temozolomide and bevacizumab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
CONTACTS
| Investor Enquiries | +852 2121 8200 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum | +44 (20) 7886 2500 |
FAQ
What were the key results of HUTCHMED's sovleplenib ESLIM-01 Phase III trial for ITP?
How many patients remained on sovleplenib treatment in the ESLIM-01 study (HCM)?
What was the safety profile of sovleplenib in the HUTCHMED ESLIM-01 trial?
