HUTCHMED Highlights Savolitinib SAVANNAH Phase II and Other Data at European Lung Cancer Congress 2025

March 20, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, PharmaceuticalEuropean Lung Cancer Congress 2025, HUTCHMED, clinical trials

  • SAVANNAH Phase II trial demonstrated high and durable response rates with savolitinib plus TAGRISSO® in MET-high lung cancer, representing a promising chemo-free oral treatment strategy to address mechanisms of resistance in the advanced setting
  • Long-term survival benefit and safety observed in savolitinib Phase IIIb study in METex14 NSCLC.

20 March 2025 — Hong Kong, Shanghai & New Jersey, US — Thursday, HUTCHMED (China) Limited
today announces that new and updated data from several studies of compounds discovered by HUTCHMED, savolitinib and surufatinib, will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place on March 26-29, 2025 in Paris, France.

Title: SAVANNAH: Savolitinib (savo) + osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and MET overexpression (OverExp) and/or amplification (Amp) following progressive disease (PD) on osi

Lead Author: Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
Session: Proffered Paper session 1
Abstract Number: #2O
Date & Time: Wednesday, March 26, 2025,16:45 Central European Time
Location: South Paris Room

Results from the SAVANNAH Phase II trial (NCT03778229) showed savolitinib (300mg BID1) plus TAGRISSO®
demonstrated a clinically meaningful and durable objective response rate (“ORR”) in patients with epidermal growth factor receptor mutated (“EGFRm”) non-small cell lung cancer (“NSCLC”) with high levels of MET overexpression and/or amplification whose disease progressed on treatment with first line TAGRISSO®.

Savolitinib plus TAGRISSO® demonstrated confirmed ORR of 56% (95% CI2: 45%–67%) and 55% (95% CI:
43%–66%), median duration of response (“DoR”) of 7.1 (95% CI: 5.6–9.6) and 9.9 (95% CI: 6.0–13.7) months,
and median progression-free survival (“PFS”) of 7.4 (95% CI: 5.5–7.6) and 7.5 (95% CI: 6.4–11.3) months by
investigator and blinded independent central review (BICR) assessment, respectively.

Safety results and discontinuation rates due to adverse events were consistent with the established profiles of each medicine and no new safety concerns were reported. In all patients treated with savolitinib (300mg BID) plus TAGRISSO®, Grade 3 or higher adverse events (AEs) occurred in 57% and Grade 3 or higher treatment related adverse events (TRAEs) occurred in 32% of the patients.

Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed and commercialized by AstraZeneca and HUTCHMED. In 2023, savolitinib and TAGRISSO® received Fast Track Designation from the US Food and Drug Administration (FDA) in this setting.

Title: Final Overall Survival and Long-term Safety Outcomes of Savolitinib in Patients with Locally Advanced or Metastatic NSCLC Harboring MET Exon 14 (METex14) Mutation: An Update from a Phase 3b Study

Lead Author: Yongfeng Yu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Session: Poster Display session
Abstract Number: #80P
Date & Time: Friday March 28, 2025,13:00 Central European Time
Location: Poster area

Updated results from the savolitinib Phase IIIb study in China demonstrated survival benefits and long-term safety in MET exon 14 skipping alteration NSCLC, particularly in treatment-naïve patients (NCT04923945). Among the 166 patients who received savolitinib treatment, the median follow-ups for 87 treatment-naïve patients and 79 previously treated patients were 34.5 and 25.1 months, respectively. In 87 treatment-naïve patients, median overall survival (“OS”) was 28.3 months (95% CI: 17.5–not evaluable), and the 36-month OS rate was 44.7%. In 79 previously treated patients, median OS was 25.3 months (95% CI: 20.5–30.5), and the 24-month OS rate was 51.7%. Post-hoc OS subgroup analysis suggested that patients with baseline brain metastasis also gain survival benefit with median OS of 15.3 months and 25.3 months in treatment-naïve patients (10/87 patients) and previously treated (21/79 patients) with brain metastasis, respectively. No new safety signal was observed.

Savolitinib is approved in China under the brand name ORPATHYS® for this patient population.

Title: Final overall survival (OS) of surufatinib plus PD-1/PD-L1 antibodies as maintenance therapy following first line (1L) platinum-based chemotherapy (Chemo) plus PD-1/PD-L1 antibodies in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC)

Lead Author: Yi Hu, Chinese PLA General Hospital, Beijing, China
Session: Poster Display session
Abstract Number: 310P
Date & Time: Friday March 28, 2025,13:00 Central European Time
Location: Poster area

Results from the exploratory study suggests surufatinib plus immunotherapy as maintenance therapy following first line chemo-immunotherapy demonstrated durable survival benefit for patients with extensive-stage small cell lung cancer (“SCLC”) patients (NCT05509699). At data cut-off on July 31, 2024, a total of 21 patients were enrolled in this single arm Phase IIa part of the study and received at least one dose of surufatinib plus PD-1/PD-L1 antibodies treatment. The median follow-up duration was 17.1 months for maintenance and 22.5 months for first line (induction + maintenance) therapy. The 12-month and 18-month OS rates were both 57.1% for maintenance therapy; and 85.7% and 57.1% for first line therapy.

About HUTCHMED
HUTCHMED 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. Since inception, it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, and the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit www.hutch-med.com.

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