HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2024 and the 2024 World Conference of Lung Cancer
HUTCHMED (HCM) announces upcoming presentations at the 2024 World Conference on Lung Cancer (WCLC24) in San Diego and the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona. Key results include the FLOWERS study, a Phase II trial of osimertinib with or without savolitinib for first-line treatment in EGFRm, MET-aberrant advanced NSCLC patients. As of May 28, 2024, the median follow-up was 8.2 months. Cohort 2 (osimertinib + savolitinib) showed a 90.5% ORR and 95.2% DCR, compared to Cohort 1's (osimertinib) 60.9% ORR and 87% DCR. Median PFS was 9.3 months in Cohort 1 and 19.6 months in Cohort 2. Safety profiles were manageable. Additional presentations cover studies of surufatinib and fruquintinib in various cancers at ESMO 2024.
HUTCHMED (HCM) annuncia le prossime presentazioni alla World Conference on Lung Cancer (WCLC24) 2024 a San Diego e al Congresso della European Society for Medical Oncology (ESMO) 2024 a Barcellona. I risultati chiave includono lo studio FLOWERS, un trial di Fase II di osimertinib con o senza savolitinib per il trattamento di prima linea nei pazienti con NSCLC avanzato con EGFRm e MET-aberrante. Al 28 maggio 2024, il follow-up mediano è stato di 8.2 mesi. Il Gruppo 2 (osimertinib + savolitinib) ha mostrato un tasso di risposta obiettiva (ORR) del 90.5% e un tasso di controllo della malattia (DCR) del 95.2%, rispetto al Gruppo 1 (osimertinib) con un ORR del 60.9% e un DCR dell'87%. La PFS mediana era di 9.3 mesi nel Gruppo 1 e 19.6 mesi nel Gruppo 2. I profili di sicurezza sono stati gestibili. Ulteriori presentazioni riguardano studi su surufatinib e fruquintinib in vari tumori all'ESMO 2024.
HUTCHMED (HCM) anuncia próximas presentaciones en la Conferencia Mundial sobre Cáncer de Pulmón (WCLC24) 2024 en San Diego y el Congreso de la Sociedad Europea de Oncología Médica (ESMO) 2024 en Barcelona. Los resultados clave incluyen el estudio FLOWERS, un ensayo de Fase II de osimertinib con o sin savolitinib para el tratamiento de primera línea en pacientes con NSCLC avanzado con EGFRm y aberración MET. A fecha del 28 de mayo de 2024, la mediana de seguimiento fue de 8.2 meses. El Grupo 2 (osimertinib + savolitinib) mostró un porcentaje de respuesta objetiva (ORR) del 90.5% y un porcentaje de control de la enfermedad (DCR) del 95.2%, en comparación con el 60.9% de ORR y el 87% de DCR del Grupo 1 (osimertinib). La mediana de PFS fue de 9.3 meses en el Grupo 1 y de 19.6 meses en el Grupo 2. Los perfiles de seguridad fueron manejables. Presentaciones adicionales cubren estudios de surufatinib y fruquintinib en varios tipos de cáncer en ESMO 2024.
HUTCHMED (HCM)은 2024년 샌디에고에서 열리는 세계 폐암 회의(WCLC24)와 2024년 바르셀로나에서 열리는 유럽 의학 종양학 회의(ESMO)에서 예정된 발표를 알립니다. 주요 결과에는 EGFRm 및 MET 변형을 가진 진행성 비소세포폐암(NSCLC) 환자에 대한 1차 치료로서 osimertinib과 savolitinib의 병행 혹은 단독 사용에 대한 제2상 임상시험인 FLOWERS 연구가 포함됩니다. 2024년 5월 28일 기준, 중간 추적 기간은 8.2개월이었습니다. 2군(오시머티닙 + 사볼리티닙)은 90.5%의 객관적 반응률(ORR)과 95.2%의 질병 관찰률(DCR)을 보였고, 1군(오시머티닙)은 60.9%의 ORR과 87%의 DCR을 보였습니다. 1군의 중간 무진행 생존 기간(PFS)은 9.3개월, 2군은 19.6개월이었습니다. 안전성 프로필은 관리 가능했습니다. 추가 발표에서는 ESMO 2024에서 다양한 암에 대한 surufatinib 및 fruquintinib 연구가 다뤄집니다.
HUTCHMED (HCM) annonce des présentations à venir lors de la Conférence mondiale sur le cancer du poumon (WCLC24) 2024 à San Diego et du Congrès de la Société européenne d'oncologie médicale (ESMO) 2024 à Barcelone. Les résultats clés incluent l'étude FLOWERS, un essai de phase II sur l'osimertinib avec ou sans savolitinib pour le traitement de première ligne chez des patients atteints de NSCLC avancé avec EGFRm et aberration MET. Au 28 mai 2024, le suivi médian était de 8,2 mois. La cohorte 2 (osimertinib + savolitinib) a montré un taux de réponse objective (ORR) de 90,5 % et un taux de contrôle de la maladie (DCR) de 95,2 %, contre 60,9 % de ORR et 87 % de DCR pour la cohorte 1 (osimertinib). La PFS médiane était de 9,3 mois dans la cohorte 1 et de 19,6 mois dans la cohorte 2. Les profils de sécurité étaient gérables. Des présentations supplémentaires portent sur des études sur le surufatinib et le fruquintinib dans divers cancers lors de l'ESMO 2024.
HUTCHMED (HCM) kündigt bevorstehende Präsentationen auf der Weltkonferenz über Lungenkrebs (WCLC24) 2024 in San Diego und dem Kongress der Europäischen Gesellschaft für Medizinische Onkologie (ESMO) 2024 in Barcelona an. Zu den wichtigsten Ergebnissen gehört die FLOWERS-Studie, eine Phase-II-Studie zu Osimertinib mit oder ohne Savolitinib zur Erstlinienbehandlung von Patienten mit EGFRm und MET-aberrantem fortgeschrittenen NSCLC. Bis zum 28. Mai 2024 betrug die mediane Nachbeobachtungszeit 8,2 Monate. Kohorte 2 (Osimertinib + Savolitinib) zeigte eine objektive Ansprechrate (ORR) von 90,5 % und eine Krankheitskontrollrate (DCR) von 95,2 %, im Vergleich zu Kohorte 1 (Osimertinib) mit einer ORR von 60,9 % und einer DCR von 87 %. Die mediane PFS betrug 9,3 Monate in Kohorte 1 und 19,6 Monate in Kohorte 2. Die Sicherheitsprofile waren handhabbar. Weitere Präsentationen behandeln Studien zu Surufatinib und Fruquintinib bei verschiedenen Krebserkrankungen auf der ESMO 2024.
- Osimertinib + savolitinib in FLOWERS study showed 90.5% ORR and 95.2% DCR.
- Median PFS improved to 19.6 months in Cohort 2 (osimertinib + savolitinib).
- Safety profiles of combination therapy were tolerable and manageable.
- Immature PFS data maturity was only 34.8% and 23.8% for Cohorts 1 and 2, respectively.
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 09, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the 2024 World Conference on Lung Cancer (“WCLC24”) in San Diego, USA, and the European Society for Medical Oncology (“ESMO”) Congress 2024, taking place in Barcelona, Spain.
Results from the FLOWERS study, a prospective, two-arm, randomized, multicenter Phase II clinical trial of osimertinib with or without savolitinib as first-line treatment in EGFRm, MET-aberrant advanced non-small cell lung cancer (“NSCLC”) patients, will be presented at WCLC24. As of May 28, 2024, the median follow-up was 8.2 months. Patients treated with osimertinib plus savolitinib (Cohort 2, N=21) showed deeper and more durable response over osimertinib monotherapy (Cohort 1, N=23) along the study follow-up. The confirmed objective response rate (ORR) in Cohort 1 and Cohort 2 were
| Abstract title | Presenter / Lead author | Presentation details |
| WCLC24 - INVESTIGATOR-INITIATED STUDIES | ||
| Osimertinib with or without savolitinib as 1L in de novo MET aberrant, EGFRm advanced NSCLC (CTONG 2008): A Phase II trial | Jinji Yang, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Southern Medical University, Guangzhou, China | PL04.10 Plenary Session PL04 Presidential Symposium 2, Plenary Hall Monday, September 9, 2024 at 8:30 AM PDT |
| Study of Surufatinib Combined with Low Dose Topotecan in Second or Third-Line Multiple Distant Organ Metastatic ES-SCLC | Yingying Du, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Hesheng Qian, Fuyang Cancer Hospital, Fuyang, China | EP.13A.04A ePoster Saturday, September 7, 2024 |
| Surufatinib Plus Docetaxel in Patients with Relapsed Advanced Driver-Negative Non-Squamous NSCLC: A Phase Ib/II Study | Qitao Yu, Wei Jiang, Guangxi Medical University Cancer Hospital, Nanning, China | P3.12C.08 Poster Monday, September 9, 2024 at 8:30 AM PDT |
Further analysis of fruquintinib’s FRESCO-2 study in metastatic colorectal cancer and FRUTIGA study in gastric cancer, a biomarker study of savolitinib in gastric cancer as well as investigator-initiated studies of fruquintinib and surufatinib will be presented at the ESMO Congress 2024. Details of the presentations are as follows:
| Abstract title | Presenter / Lead author | Presentation details |
| ESMO 2024 - SPONSORED STUDIES | ||
| Efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer with and without liver metastasis: A subgroup analysis of the phase 3 FRESCO-2 trial | Rocio Garcia-Carbonero, Hospital Universitario 12 de Octubre, lmas12, UCM, Madrid, Spain | 520P Poster Session – Colorectal cancer Monday, 16 September 2024 |
| Efficacy and safety of fruquintinib in refractory metastatic colorectal cancer: A FRESCO-2 subgroup analysis by age | Maria Elena Elez Fernandez, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain | 526P Poster Session – Colorectal cancer Monday, 16 September 2024 |
| Efficacy of fruquintinib plus paclitaxel (F+PTX) in patients (pts) with prior immunotherapy (prior-IO): subgroup analysis from FRUTIGA study | Lin Shen, Peking University Cancer Hospital & Institute, Beijing, China | 1410P Poster Session – Oesophagogastric cancer Monday, 16 September 2024 |
| Impact of subsequent anti-tumor therapies in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma receiving fruquintinib (F) plus paclitaxel (PTX) or placebo plus PTX in FRUTIGA study | Ruihua Xu, Sun Yat-sen University Cancer Center, Guangzhou, China | 1434P Poster Session – Oesophagogastric cancer Monday, 16 September 2024 |
| Association between Fruquintinib-induced Hypertension and Clinical Outcomes from FRUTIGA, a Phase 3 Study of Fruquintinib plus Paclitaxel in Previously Treated Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma | Shukui Qin, Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital, Nanjing, China | 1443P Poster Session – Oesophagogastric cancer Monday, 16 September 2024 |
| Analysis of MET gene alterations in cfDNA samples from a phase II study of savolitinib in patients (pts) with MET-amplified gastroesophageal junction adenocarcinomas or gastric cancer (GEJ/GC) | Zhi Peng, Peking University Cancer Hospital & Institute, Beijing, China | 1461P Poster Session – Oesophagogastric cancer Monday, 16 September 2024 |
| ESMO 2024 - INVESTIGATOR-INITIATED STUDIES | ||
| A phase II clinical study of fruquintinib (Fru) combined with toripalimab (Tor) and short-course radiotherapy (SCRT) as neoadjuvant therapy for locally advanced rectal cancer (LARC) | Zhiping Li, Ye Chen, West China Hospital of Sichuan University, Chengdu, China | 570P Poster Session – Colorectal cancer Monday, 16 September 2024 |
| Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: Updated findings from a single-arm, prospective phase II trial (RIFLE) | Zhen Zhang, Yajie Chen, Fudan University Shanghai Cancer Center, Shanghai, China | 537P Poster Session – Colorectal cancer Monday, 16 September 2024 |
| Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results | Yongqian Shu, Pei Ma, Jiangsu Province Hospital/The First Affiliated Hospital of Nanjing Medical University, Nanjing, China | 1329P Poster Session – NSCLC, metastatic Saturday, 14 September 2024 |
| Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION) | Xiaobing Chen, Beibei Chen, Henan Cancer Hospital/ Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China | 1475TiP Poster Session – Oesophagogastric cancer Monday, 16 September 2024 |
| Fruquintinib combined with nab-paclitaxel and gemcitabine (AG) as the first-line treatment for pancreatic ductal adenocarcinoma (PDAC) with liver metastases: An open-label, single-arm, single-center phase II clinical study | Xianjun Yu, Miaoyan Wei, Fudan University Shanghai Cancer Center, Shanghai, China | 1529P Poster Session – Pancreatic cancer Monday, 16 September 2024 |
| A phase II study of Fruquintinib in the 1L or 2L treatment of unresectable metastatic soft tissue sarcoma | Zhiguo Luo, Xiaowei Zhang, Fudan University Shanghai Cancer Center, Shanghai, China | 1743P Poster Session – Sarcoma Saturday, 14 September 2024 |
| Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study | Fuxiang Zhou, Zhongnan Hospital, Wuhan University, Wuhan, China | 974P Poster Session – Hepatocellular carcinoma (HCC) Monday, 16 September 2024 |
| Updated results of Surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trial | Dan Cao, West China Hospital, Sichuan University, Chengdu, China | 1155P Poster Session – Neuroendocrine tumours Monday, 16 September 2024 |
| Surufatinib plus toripalimab combined with pemetrexed (A), and platinum (P) in patients (pts) with advanced non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results of a single-center, phase II trial | Li Zhang, Wenfeng Fang, Sun Yat-Sen University Cancer Center, Guangzhou, China | 1345P Poster Session – NSCLC, metastatic Saturday, 14 September 2024 |
| Surufatinib combined with gemcitabine in soft tissue sarcoma (STS) patients failed with anthracyclines chemotherapy or monotherapy post-anlotinib progression: a multi-center, phase II trial | Xiaohui Niu, Yuhong Zhou, Zhongshan Hospital, Fudan University, Shanghai, China | 1740P Poster Session – Sarcoma Saturday, 14 September 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 marketed in the US and Europe. 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 and surufatinib, the further clinical development for fruquintinib, savolitinib and surufatinib, its expectations as to whether any studies on fruquintinib, savolitinib 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 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 and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of CAPEOX, docetaxel, gemcitabine, nab-paclitaxel, paclitaxel, pemetrexed, platinum, sintilimab, topotecan, tislelizumab or toripalimab 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
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